Biological indicators, systems, and methods for determining the effectiveness of sterilization

Abstract

The biological indicator includes a BI housing, a germinant container that holds a germinant composition within the BI housing, a germinant releaser configured to release the germinant composition from the germinant container, a germinant releaser support that supports the germinant releaser, the germinant releaser support configured to bring the germinant releaser into contact with the germinant container when a force is applied to the germinant releaser support or the germinant container, a first spore carrier within the BI housing, the first spore carrier having a plurality of spores deposited on a first side thereof, and an imaging window on a first face of the BI housing. The BI reader is configured to detect and quantify the presence of viable spores within the BI and includes an excitation source, a camera for capturing images of the spores over time, and a processor for analyzing the images to determine the presence of viable spores.

Description

[Background technology]

[0001] In some industries, certain equipment needs to be sterilized before it can be reused. One of the largest and most well-known industries with such a need is the medical industry, where a wide range of equipment, from surgical instruments to routine medical devices and certain implants, must be sterilized to ensure safety in use. Generally, sterilization procedures are designed to kill all viable living organisms within a sterile chamber. However, sterilization can be challenging because objects can be contaminated with numerous different types of bacteria, each with varying degrees of hazard and difficulty in killing them. Therefore, it is common practice (and in some industries, essential) to test the effectiveness of each sterilization process to determine whether the equipment subjected to the process has been successfully sterilized.

[0002] To assess whether sterilization was successful (e.g., whether lethal conditions were adequately met), sterilization indicators are typically subjected to the sterilization process along with the equipment being sterilized. These sterilization indicators are then analyzed to determine whether the sterilization of the equipment processed together was successful. One type of sterilization indicator is the chemical indicator, which responds to one or more critical parameters of the sterilization process and typically has a moving front mechanism with a color change or endpoint to provide information about the sterilization process. However, chemical indicators can be unreliable because they only provide a rough measure of sterilization success.

[0003] Another type of sterilization indicator known as a biological indicator (or "bioindicator") typically contains a population of bacterial spores encapsulated within the indicator, which is subjected to the same sterilization process as the equipment being sterilized. Current sterilization assurance techniques using biological indicators utilize assays that require at least one day for direct measurement of microbial survival within the biological indicator (and at least 20 minutes for indirect measurement). Most of these assays rely on indirect measurement of microbial survival and do not quantify it. For example, indirect measurement is used to examine overall changes in a specific metric, such as fluorescence, to determine whether sterilization was likely effective. However, the accuracy of such indirect measurements is susceptible to exogenous factors unrelated to the biological changes of interest, making these indirect methods unreliable. Furthermore, current sterilization assurance techniques often rely on these non-quantitative measurements of microbial survival, simply returning a positive result (microbial survival, thus indicating sterilization failure) or a negative result (non-detection of microbial survival, thus indicating sterilization success). Due to the nature of these conventional assays, positive or negative results may only be returned after 24 hours (for direct measurements) or 20 minutes (for indirect measurements). [Overview of the Initiative] [Means for solving the problem]

[0004] According to embodiments of the present disclosure, a device, system, and method for determining the effectiveness of a sterilization process (or “treatment”) can return a sterilization assurance result within a fraction of the time currently required when using conventional tools and methods. Aspects of embodiments of the present disclosure are directed to biological indicators, process challenge devices, and biological indicator readers with improved accuracy in determining the effectiveness of a sterilization process (or “treatment”). Aspects of embodiments of the present disclosure provide for parallel sterilization testing of multiple biological indicators in a biological indicator reader, thereby enabling relatively rapid sterilization assurance with the same device. Aspects of embodiments of the present disclosure also provide biological indicators and biological indicator readers that provide a direct measurement of the presence of viable spore(s) in a biological indicator after sterilization.

[0005] The accompanying drawings are included to provide a further understanding of the exemplary embodiments of the present disclosure, are incorporated herein, and form a part of this specification. The drawings illustrate the exemplary embodiments of the present disclosure and, together with the description, serve to clarify the principles of the inventive concept(s) of the present disclosure. In the drawings, like reference numerals refer to like elements throughout, unless otherwise specified.

Brief Description of the Drawings

[0006] [Figure 1] A perspective view of a biological indicator (BI) according to an embodiment of the present disclosure. [Figure 2] A side view of the biological indicator (BI) of FIG. 1. [Figure 3] A top view of the first outer contour of the biological indicator (BI) of FIG. 1. [Figure 4] A cross-sectional view of the first outer contour of FIG. 3 taken along line IV-IV of FIG. 3. [Figure 5] A top view of the second outer contour of the biological indicator (BI) of FIG. 1. [Figure 6] A cross-sectional view of the second outer contour of FIG. 5 taken along line VI-VI of FIG. 5. [Figure 7]Figure 5 is a bottom view of the second outer structure. [Figure 8] This is a perspective view of a germinator releaser support according to an embodiment of the present disclosure. [Figure 9] Figure 8 is a top view of the support structure of the germination agent releaser. [Figure 10] This is a cross-sectional view of the germination agent releaser support in Figure 9, along line XX in Figure 9. [Figure 11] Figure 8 is a bottom view of the support structure of the germination agent releaser. [Figure 12] This is a decomposed perspective view of a biological indicator (BI) according to an embodiment of the present disclosure. [Figure 13] This is a decomposed perspective view of a biological indicator (BI) according to an embodiment of the present disclosure. [Figure 14] Figure 13 is a cross-sectional view of the second outer layer of the biological indicator (BI). [Figure 15] Figure 13 is a perspective view of the germination container for the biological indicator (BI). [Figure 16A] Figure 15 is a top view of the germination agent container. [Figure 16B] Figure 15 is a bottom view of the germination agent container. [Figure 17] Figure 13 is a perspective view of the biological indicator (BI) germination agent releaser. [Figure 18] Figure 17 is a top view of the germination agent Releaser. [Figure 19] This is a bottom view of a process challenge device according to an embodiment of the present disclosure. [Figure 20] Figure 19 is a side view of the process challenge device. [Figure 21] Figure 19 is a perspective view of the process challenge device tray. [Figure 22] This is a top view of a steam sterilization integrator according to an embodiment of the present disclosure. [Figure 23] Figure 22 is a perspective view of the bottom of the steam sterilization integrator. [Figure 24] Figure 19 is an exploded perspective view of the process challenge device. [Figure 25] This is a perspective view of a tray for a process challenge device according to an embodiment of the present disclosure. [Figure 26] Figure 25 is a side view of the process challenge device tray. [Figure 27] This is a cross-sectional view of the tray in Figure 26 along the line XXVII-XXVII in Figure 26. [Figure 28] Figure 25 is an exploded perspective view of the process challenge device and biological indicator (BI) according to an embodiment of the present disclosure. [Figure 29] This is a perspective view of a biological indicator (BI) reader according to an embodiment of the present disclosure. [Figure 30] Figure 29 is a front view of the front panel of the Biological Indicator (BI) reader. [Figure 31] Figure 30 is a perspective view of the rear of the front panel. [Figure 32] Figure 29 is an exploded perspective view of the front panel assembly of the biological indicator (BI) reader. [Figure 33] Figure 29 is a perspective view of the access door of the front panel assembly of the biological indicator (BI) reader. [Figure 34] Figure 29 is a side view of the access door mounted on the front panel of the biological indicator (BI) reader in an open configuration. [Figure 35] Figure 29 is a perspective view of the heater block assembly of the biological indicator (BI) reader. [Figure 36] Figure 35 is an exploded perspective view of the heater block assembly. [Figure 37] Figure 35 is a top view of the biological indicator bay of the first plate of the heater block assembly, before the biological indicator (BI) is inserted according to an embodiment of the present disclosure. [Figure 38] Figure 35 is a top view of the biological indicator (BI) bay of the first plate of the heater block assembly while a biological indicator (BI) is being inserted, according to an embodiment of the present disclosure. [Figure 39] Figure 35 is a top view of the biological indicator (BI) bay of the first plate of the heater block assembly after the biological indicator (BI) has been inserted according to an embodiment of the present disclosure. [Figure 40] Figure 35 is a top perspective view of the second plate of the heater block assembly. [Figure 41] Figure 40 is a bottom perspective view of the second plate. [Figure 42] Figure 35 is a side view of the biological indicator (BI) bay of the heater block assembly, with the biological indicator (BI) reader in operation after the biological indicator (BI) has been inserted. [Figure 43] Figure 35 is a perspective view of the shuttle in the heater block assembly. [Figure 44] Figure 43 is an exploded perspective view of the shuttle. [Figure 45] This is a side view of a shuttle having a door interlock spring and access door for a biological indicator (BI) reader according to an embodiment of the present disclosure. [Figure 46] This is a bottom perspective view of a self-calibration target according to an embodiment of the present disclosure. [Figure 47] This is a perspective view of a heater block assembly, a positioning assembly, a mirror mount, and a camera assembly according to embodiments of the present disclosure. [Figure 48] Figure 47 is a perspective view of the positioning assembly. [Figure 49] Figure 47 is an exploded perspective view of the scan head assembly of the positioning assembly. [Figure 50] Figure 47 is a perspective view of the mirror mount. [Figure 51A] Figure 47 is a perspective view of the camera assembly. [Figure 51B] Figure 51A is an exploded perspective view of the camera assembly. [Figure 52A] Figure 47 is a rear perspective view of the camera assembly. [Figure 52B] Figure 47 is a front view of the fan guard of the camera assembly. [Figure 53] Figure 29 is a rear view of the Biological Indicator (BI) reader. [Figure 54] Figure 29 is a disassembled perspective view of a biological indicator (BI) reader. [Figure 55] This is a schematic diagram of a control system according to an embodiment of the present disclosure. [Figure 56] This is a schematic diagram of a position adjustment assembly control module in a control system according to an embodiment of the present disclosure. [Figure 57] This is a schematic diagram of a biological indicator (BI) bay heater control module in a control system according to an embodiment of the present disclosure. [Figure 58] This is a schematic diagram of the control modules for a biological indicator (BI) bay door and handler in a control system according to an embodiment of the present disclosure. [Figure 59] This is a schematic diagram of a camera control module in a control system according to an embodiment of the present disclosure. [Figure 60] This is a schematic diagram of an excitation control module in a control system according to an embodiment of the present disclosure. [Figure 61] This is a schematic diagram of a user interface control module in a control system according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0007] According to embodiments of the present disclosure, the biological indicator reader, method, and system provide accurate determination of sterilization effectiveness in a fraction of the time currently required when using conventional tools and methods. For example, while many conventional sterilization effectiveness techniques take more than 24 hours to provide notification of whether sterilization was successful, the BI reader, system, and method according to embodiments of the present disclosure can return an effectiveness determination in just a few minutes. This represents a dramatic improvement over conventional sterilization effectiveness techniques, allowing instruments subjected to inspection sterilization to be used much sooner than when using current sterilization effectiveness inspection techniques.

[0008] Embodiments of this disclosure relate to systems for determining the effectiveness of a sterilization process (also interchangeably referred to herein as “sterilization treatment”). Throughout this disclosure and the accompanying claims, “determining the effectiveness of a sterilization process” is used interchangeably with the phrase “sterilization assurance,” both terms referring to the same thing, namely, evaluating whether a sterilization process (or treatment) has been successful (e.g., killing bacterial spores in a biological indicator). Embodiments of this disclosure relate to a biological indicator (or “biometer” or “BI”) 100, a process challenge device (also interchangeably referred to herein as “PCD”) 200, and a bioindicator reader (also interchangeably referred to herein as “biometer reader” or “BI reader”) 300. Embodiments of this disclosure further relate to a method for determining sterilization effectiveness using the biological indicator 100 and / or PCD 200, and the BI reader 300. For example, in some embodiments of the present disclosure, the method may include subjecting the BI 100 and / or PCD 200 to a sterilization procedure (or sterilization treatment), and after the completion of the sterilization treatment, inserting the biological indicator 100 into a BI reader 300, the BI reader 300 then inspecting the biological indicator 100 to determine whether the sterilization treatment the BI underwent was effective.

[0009] Referring to Figures 1 to 12, according to an exemplary embodiment, the biological indicator 100 includes a BI housing 110, a germination container 160, a germination releaser 170, a spore carrier 180, and an imaging window 190. The BI housing 110 houses the germination container 160, the germination releaser 170, and the spore carrier 180. As will be discussed in more detail below, the imaging window 190 allows the optical assembly of the BI reader 300 to image spore activity in the spore carrier 180.

[0010] The BI housing 110 is not particularly limited and may have any suitable shape such that, as further discussed below, the BI housing 110 can accommodate the germination agent container 160, the germination agent releaser 170, and the spore carrier 180, and the BI housing 110 can be received by the BI reader 300, and in some embodiments, the BI housing 110 can be received by the PCD 200. According to an embodiment, for example, the BI housing 110 has a substantially oval shape (i.e., a substantially stadium shape) in a plan view, and the length direction Y of the BI housing 110 ,

[0012] has the BI length L along BI which is greater than the BI width W along the width direction X of the BI housing 110 BI . The BI length L BI and the BI width W BI are not particularly limited but may be selected to fit within the BI reader 300. For example, in some embodiments, the BI length L is selected such that the user can relatively easily grip the biological indicator 100 at the opposite second end 100b to facilitate inserting the first end 100a of the biological indicator 100 into the BI reader 300. In some embodiments, for example, the BI length L BI can be about 2 to 4 times greater than the BI width W, for example, about 2 to 3 times greater, about 2.5 to 3 times greater, about 2.6 to about 2.9 times greater, or about 2.75 to about 2 times greater than the BI width W BI . BI is BI about BI 2.8 times greater. <000023​​​​​​In embodiments including a fitted first and second outer casing 120 and 130, the configuration and fitting contour of the first and second outer casings 120 and 130 are similarly not particularly limited and may be any configuration or fitting contour suitable for securely sealing the contents housed within the BI enclosure 110. For example, in some embodiments, the first and second outer casings 120 and 130 may typically be fitted along the outer perimeter 115 of the BI enclosure 110. The outer perimeter 115 may typically evenly bisect the thickness of the BI enclosure. However, in some embodiments, as generally shown in Figures 1 and 2, the outer perimeter 115 may be inclined or oblique with respect to the thickness dimension of the BI enclosure, thereby creating a thin end 130a and a thick end 130b of the second (or lower) outer casing (as shown, for example, in Figure 6).

[0013] The material of the BI enclosure 110 is not particularly limited and can be any material that can withstand the sterile conditions (e.g., autoclaving) to which it is exposed during inspection and sterilization, and that can safely and securely house the contents of the BI enclosure 110. Some non-limiting examples of such materials for the BI enclosure 110 include polypropylene homopolymer.

[0014] Referring to Figure 3, according to the embodiment, the first outer shell 120 has a gripping portion 120b at the second end 100b that extends toward the first end 100a, and at the first end 100a, a gripping portion 120b that extends toward the thickness direction Z of the biological indicator 100 from the gripping portion 120b. BI It has a raised portion 120a that protrudes (for example, when the BI housing 110 is assembled, the raised portion 120a protrudes away from the second outer casing 130). In some embodiments, the raised portion 120a may be substantially circular when viewed in plan, but the disclosure is not limited thereto, and the raised portion may have any suitable shape that allows the BI 100 to fit inside the BI reader 300. The diameter (or other dimensions) of the raised portion 120a is typically the width W of the BI. BI This may correspond to (or be equivalent to) the above, but as before, the disclosure is not limited thereto, and the raised portion 120a may have any suitable dimensions (width W of the BI) as long as the BI fits within the leader. BI(Including dimensions that may extend beyond the above). As will be further discussed below, the raised portion 120a (together with the corresponding portion of the second outer shell 130) defines a cavity inside the BI housing 110, where the germination agent releaser 170, at least a portion of the germination agent container 160, and the spore carrier 180 are housed.

[0015] According to one embodiment, the raised portion 120a may define an opening (e.g., a through hole) 121, which is configured to receive a germinator release lever 401 in the BI reader 300. As will be further discussed below, when the germinator release lever 401 is activated, the opening 121 allows the germinator container 160 to burst. According to one embodiment, the opening 121 may be sealed to prevent the sterilizer from entering before the BI is activated. Any suitable sealant material may be used for this purpose, and a non-limiting example of such a sealant is a foil sealant. When the BI is activated, the germinator release lever 401 breaks the seal as it enters the opening 121. However, if the biological indicator 100 is placed in an autoclave chamber or other sterilization chamber, the opening 121 may also remain open (i.e., the seal may be omitted) to allow the sterilizer to enter the BI housing 110. As shown in Figures 1, 3, and 4, the opening 121 is typically located in the center of the raised portion 120a, but the disclosure is not limited thereto. As will be further discussed below, the opening 121 can actually be located anywhere on the raised portion, provided that the germination release lever 401 of the BI reader 300 can enter the opening when activated, and the position of the opening 121 makes it possible to activate the germination release lever 401 to burst the germination container 160.

[0016] In some embodiments, to prevent the sterilizing agent from entering through the opening 121, the opening 121 may be sealed, for example, by heat sealing with foil (as discussed above). In such embodiments, the BI housing 110 may include a sterilizing agent opening 121' (see Figure 6), which is separate from the opening 121 and provides an alternative (or additional) route for the sterilizing agent (e.g., steam) to enter the BI housing 110 during sterilization. The sterilizing agent opening 121' may be located at any suitable location on the BI housing 110, including either on the first outer casing 120 or on the second outer casing 130. In some embodiments, for example, the sterilizing agent opening 121' may be a defined through-hole in the second end 100b of the BI housing 110, for example in the second outer casing 130 (as shown in Figure 6). In some embodiments, the sterilizer opening 121' may be a through-hole defined in the recess 137a of the second outer shell 130, as will be discussed further below (see Figure 14). Furthermore, although the sterilizer opening 121' is discussed here in relation to embodiments in which the opening 121 is sealed to prevent the entry of sterilizer, in some embodiments, the BI may have both an unsealed opening 121 (allowing the entry of sterilizer) and a sterilizer opening 121' (providing an additional passage for the entry of sterilizer).

[0017] According to the embodiment, the first outer casing 120 may further include a visual indicator 122, such as an arrow or a triangle, that points in the direction of the first end 100a, corresponding to the direction in which the biological indicator 100 is inserted into the BI reader 300. The gripping portion 120b may include a label portion 123 configured to receive a label 126 (e.g., a sticker) for easy marking and / or labeling of the biological indicator 100 (see, for example, Figure 12). The label portion 123 may also have a more oval shape with a smaller diameter, but the disclosure is not limited thereto, and the label portion 123 may have any suitable shape so that a user can add identification information to the surface of the gripping portion 120b. According to the embodiment, the label portion 123 is not textured (e.g., smooth) so that stickers can be easily applied to and / or removed and / or the user can easily write directly on the label portion 123. In some embodiments, the label portion 123 is defined by a recess (or depression) on the surface of the first outer casing (as schematically shown in Figure 1). However, it will be understood that the label portion 123 may simply be a part of the surface of the gripping portion 120b of the first outer casing 120 and may not be defined by a visually identifiable artifact or discontinuity on the surface of the first outer casing 120 (i.e., the surface of the gripping portion 120b of the first outer casing 120 may be substantially continuous and smooth).

[0018] Referring to Figure 4, according to some embodiments, when the BI enclosure 120 is assembled, the lower edge of the first outer shell 120 is in the longitudinal direction Y BI An angle can be applied to it. For example, at least a portion of the upper surface of the first outer shell 120 is in the longitudinal direction Y BI To avoid being parallel to the longitudinal direction Y, the upper surface of the first outer shell 120 is... BI Angle θ relative to this BI It can form a longitudinal direction Y. BI Angle θ BIThis can be made by the thicker end 130a and the thinner end 130b of the second outer shell 130. In such embodiments, the first outer shell 120, when considered alone (unfitted with the second outer shell), has a length in the Y direction. BI It may have a contour that is roughly parallel to the first, but when assembled (i.e., fitted) with the second outer shell, it obtains a non-parallel (i.e., inclined or oblique) contour.

[0019] According to an exemplary embodiment, the inner surface 124 of the first outer casing 120 may include one or more (or in some embodiments, more) grooves 125 along its outer circumference, which are configured to engage (e.g., tightly engage) with corresponding projections 139 on the outer circumference of the second outer casing 130. However, the fitting configuration of the first outer casing 120 and the second outer casing 130 is not limited to this interaction between the grooves 125 and projections 139, and instead may be any configuration suitable for tightly closing the BI housing 110 so that it can withstand the conditions of the sterilization process that the BI housing 110 is to undergo. For example, any suitable snap-fit, friction-fit, or clamp-fit ​​engagement may be used between the first and second outer casings, or the first and second outer casings may be more permanently attached to each other, for example, by adhesive.

[0020] Referring to Figures 5 to 7, according to the embodiment, the second outer shell 130 also has a substantially oval shape when viewed in plan. The bottom 131 of the second outer shell 130 defines a bottom opening (e.g., a through hole) 132 that receives the imaging window 190. The bottom opening 132 is formed in the region of the first end 100a of the biological indicator 100. According to the embodiment, when the first outer shell 120 and the second outer shell 130 of the BI housing 110 are fitted together, the center C of the bottom opening 132 is in the thickness direction Z BI The opening 121 is aligned along this line (for example, stacked directly below). However, it will be understood that the bottom opening 132 is not limited to this and can be positioned anywhere on the second outer shell 130 so as to be able to receive the imaging window and so as to be able to image spores through the imaging window.

[0021] According to the embodiment, the bottom opening 132 may have an "Odin's cross" shape, as shown in Figures 5 and 7. For example, the bottom opening 132 may have a circular portion and a plurality of projections extending from the circular portion, for example, four equilateral cross-shaped projections extending beyond the circular portion. However, embodiments of the present disclosure are not limited thereto, and the bottom opening 132 may have any suitable shape. The exemplary Odin's cross shape of the bottom opening 132 can reduce the possibility of the spore carrier 180 swelling by allowing air to pass through the projection region, thereby maintaining equal (or substantially equal) pressure on both sides of the spore carrier 180.

[0022] Referring to Figure 7, the bottom 131 of the second outer shell 130 further includes a window notch 133, which surrounds the bottom opening 132 and is configured to receive the imaging window 190 within the window notch 133.

[0023] According to some embodiments, the imaging window is transparent, so that the bottom opening 132 can be seen, which facilitates the identification of the precise alignment of the biological indicator 100 when inserting the biological indicator 100 into the BI reader 300. The imaging window 190 can be made of any suitable material, without limitation. Some non-limiting examples of such suitable materials include thermoplastic polymers, such as polymethylpentene. According to some embodiments, the biological indicator 100 may further include a retaining ring 191 that holds the imaging window 190 in the bottom opening 132. The retaining ring 191 can be made of any suitable material, without limitation, such as aluminum 6061. The window notch 133 may be circular so that the imaging window 190 and the retaining ring 191 can be inserted into the window notch 133 relatively easily. However, the disclosure is not limited thereto, and the window notch 133 may have any suitable shape. The retaining ring 191 does not, for example, create an airtight seal, but it can seal the imaging window 190 to the window notch 133 while still preventing airborne organisms from entering the BI housing 110 through the bottom opening 132.

[0024] According to some embodiments, the second outer shell 130 may further include a channel 134 for holding a germination container 160. For example, the channel 134 may be formed near the center of the biological indicator 100 and may have an open end facing the first end 100a of the biological indicator 100. However, the location of the channel is not limited thereto and can be placed anywhere within the second outer shell that is suitable for holding the germination container 160. In some embodiments, the channel 134 may be defined by a channel wall 135 having a substantially U-shape when viewed in plan, and the channel wall 135 is in the thickness direction Z away from the bottom 131 of the second outer shell 130. BIIt extends to the bottom 131. In some embodiments, the channel wall 135 may be formed by creating a pair of grooves extending from the bottom 131, for example, as shown in Figure 7. As shown in Figure 5, the channel wall 135 may include one or more connecting portions 135a, which connect the U-shaped channel wall 135 to the side wall 136 of the second outer casing 130. In some embodiments, to increase the stability of the channel wall 135, the second outer casing 130 may include a plurality of connecting portions 135a. The channel bottom surface 135b may have a shape substantially corresponding to the shape of the germination container 160. For example, the channel bottom surface 135b may have a rounded or chamfered shape to accommodate a germination container 160 that may have a rounded vial shape. The channel bottom surface 135b may also vary in thickness so that the channel bottom surface 135b slopes toward the first end 100a of the biological indicator 100 (see, for example, Figure 6).

[0025] According to this embodiment, the channel wall 135 is angled to receive the germination container 160. Therefore, the germination 165 flows downward due to gravity, which can further promote contact between the germination 165 and the germination pad 185.

[0026] According to one embodiment, the second outer shell 130 may further include a projection 137 in the region of the second end 100b of the biological indicator 100, which is in the longitudinal direction Y BI It is positioned between the side wall 136 and the channel wall 135 along the width W of the biological indicator 100. BI The projection may have a circular shape with a diameter slightly smaller than the second outer shell 130, thereby forming a recess 137a on the outer surface of the bottom 131 of the second outer shell 130. However, the disclosure is not limited thereto, and the projection 137 may have any suitable shape and / or may be omitted. According to some embodiments, the recess 137a may be sized to receive a process indicator 137b indicating whether the biological indicator 100 has been exposed to a sterilizing agent.

[0027] The second outer shell 130 further extends in the thickness direction Z from the bottom 131. BIIt includes a side wall 136 extending to the first end 100a. The outward-facing surface of the side wall 136 may include an insertion groove 138 at the first end 100a, which has a substantially U-shape. The insertion groove 138 is configured to engage with the BI bay 375 and / or BI latch 384 of the BI reader 300, thereby facilitating the proper insertion of the biological indicator 100 into the BI reader 300. The insertion groove 138 may also include insertion projections 138a on both sides of the insertion groove 138 near each end of the insertion groove 138, which each define an insertion notch 138b at each end of the insertion groove 138, as shown in Figure 2. For example, an insertion notch 138b is defined to receive the rib 387 of the BI latch 384, and the removal of the biological indicator 100 is inhibited while the BI latch 384 is in contact with the biological indicator 100. After the biological indicator 100 is inserted into the BI bay 375 of the BI reader 300, the insertion projection 138a allows the BI latch 384 to firmly hold the biological indicator 100 in place. The insertion groove 138 may be positioned to surround the first end 100a of the biological indicator 100 and may be symmetrical on both sides of the biological indicator 100, but is not limited thereto. According to embodiments, the biological indicator 100 may include the insertion notch 138b and the insertion projection 138a on only one side of the insertion groove 138.

[0028] The second outer casing 130 may further include projections 139 on the outer surface of the side wall 136, which are configured to fit securely into grooves 125 of the first outer casing 120. According to embodiments, it will be understood that the grooves 125 may be formed in the second outer casing 130, and the projections 139 may be formed in the first outer casing 120. Furthermore, other means for securely fastening the first outer casing 120 and the second outer casing 130 may be used, as are known in the art and generally discussed above. At least a portion of the upper edge of the side wall 136 is at an angle θ BI It will also be understood that it can be formed at an angle equal to but with opposite positive and negative values. In other words, at least a portion of the side wall 136 is in the longitudinal direction Y such that the first outer shell 120 and the second outer shell 130 fit together snugly. BI From there downwards at an angle θBI It can be formed by (see, for example, Figures 6 and 2).

[0029] According to the embodiment, the biological indicator 100 may further include a germination agent releaser support 140, which is housed within the BI housing 110, for example, near the first end 100a of the biological indicator 100, under the raised portion 120a of the first outer casing 120. The germination agent releaser support 140 houses (or accommodates) the germination agent releaser 170, and the germination agent releaser support 140 is, for example, in the thickness direction Z BI The germination agent releaser 170 is configured to come into contact with the germination agent container 160 by applying force to it. According to an exemplary embodiment, the germination agent releaser support 140 may have a saddle shape.

[0030] Referring to Figures 8-11, according to some embodiments, the germination releaser support 140 may include a base 141, a plurality of support legs 142, a central leg 143, a germination releaser opening 144, and a tab 145. The base 141 may have a substantially semicircular shape when viewed in plan, with the rounded portion facing the first end 100a of the biological indicator 100. According to the embodiments, the width direction X BI The width of the base 141 along the BI is the width W BI It is smaller. Therefore, the germination agent releaser support 140 can be easily installed in the BI enclosure 110 without interfering with the BI enclosure 110.

[0031] Each of the support legs 142 is in the longitudinal direction Y BI An extension portion 142a extends away from the base 141 toward the second end 100b along the same direction, and from the end of the extension portion 142a on the opposite side of the base 141 toward the thickness direction Z BI It may include a protruding portion 142b extending downward. When the biological indicator 100 is assembled, the support leg 142 spans the channel 134 and the germination container 160, with the support leg 142 extending in the width direction X BI Support legs 142 may be formed at both ends of the base 141 along the thickness direction Z from the upper surface 141a of the base 141. BIIt can be positioned offset. When the germinator release support 140 is inserted into the BI housing 110, the protruding portion 142b is configured to extend beyond the connecting portion of the connecting portion 135a, thereby maintaining the relative position of the germinator release support 140. According to one embodiment, the support leg 142 is positioned on the base 141 at a height such that the extension portion 142a rests on the upper surface of the connecting portion 135a. As discussed above, this configuration allows for relatively easy positioning and alignment of the germinator release support 140 without the need for crevice fitting or interlock fitting, which can cause problems and delays during manufacturing and limit the flexibility of the germinator release support 140 when a downward force is applied to it.

[0032] The central leg 143 may include a central leg extension 143a and a central leg projection 143b. The central leg 143 is positioned in the width direction X such that the central leg 143 is positioned above the channel 134 and the germination container 160 when the biological indicator 100 is assembled. BI The central leg 143 may be positioned approximately in the center of the base 141 along the Y-axis. However, the disclosure is not limited thereto, and as will be further discussed below, the central leg 143 may be positioned anywhere on the germination releaser support 140, as long as it is maintained in contact with the germination container 160. The central leg extension 143a is in the longitudinal direction Y BI It may extend away from the base 141 along the longitudinal direction Y BI A length shorter than the length of the support leg 142 along the longitudinal direction Y BI It may have. When the germination agent container 160 and the germination agent releaser support 140 are inside the BI housing 110, the central leg 143 is configured to be positioned on top of the germination agent container 160. As will be further discussed below, the central leg projection 143b is in the thickness direction Z BI It extends downward and is configured to contact the germinator container 160 when force is applied to the germinator release support 140 (for example, when the germinator release lever 401 of the BI reader 300 is activated), acting as a spring that concentrates the downward force of the germinator releaser 170 onto the germinator container 160.

[0033] The support legs 142 provide support in the thickness direction Z BI To allow for flexible movement of the germination agent releaser support 140 along the (thickness direction Z), the germination agent releaser support 140 can be made of any suitable material. For example, the germination agent releaser support 140 can be formed of a polymer material (non-limiting examples including polypropylene, etc.), which is (thickness direction Z) BI It has enough elasticity to allow movement of the base 141 when a downward pressure is applied (along the channel 134), but has enough strength to maintain the support leg 142 in place relative to the channel 134.

[0034] According to the embodiment, the germinator release support 140 further includes a tab 145 projecting downward from the base 141. When the BI is in a non-activated state, the central leg projection 143b and the tab 145 are spaced perpendicularly apart from the surface of the germinator container 160. As discussed above, when the BI is activated (i.e., when the germinator release lever 401 of the BI reader 300 is activated), the force applied by the germinator release lever 401 overcomes the spring force of the support leg 142, and then the central leg projection 143b and the tab 145 come into contact with the germinator container 160. At this contact, the central leg projection 143b and the tab 145 each act as springs that concentrate the downward force of the germinator releaser 170 onto the germinator container 160 (for example, across the diameter of the germinator container).

[0035] The base 141 further defines a germinator releaser opening 144, which is configured to receive the germinator releaser 170 and maintain the position of the germinator releaser 170 and the germinator releaser support 140. For example, the germinator releaser opening 144 is in the width direction X BI It may have a substantially cylindrical shape with a length along the width direction. According to the embodiment, the length of the germinator releaser opening 144 is such that the germinator releaser 170 reliably contacts the germinator container 160 when the germinator release lever 401 of the BI reader is operated (as further discussed below), in the width direction X BIThe width of the germination container 160 is greater than the width of the germination container 160 along the germination release opening 144. The germination release opening 144 may include one or more stoppers 146 extending toward each other along the length of the germination release opening 144. The stoppers 146 function to prevent the germination releaser 170 from coming out of the germination release opening 144 above the base 141 when downward pressure is applied to the germination releaser support 140. In other words, the stoppers 146 function to keep the germination releaser 170 inside the germination release opening 144 when the germination release lever 401 of the BI reader 300 is activated (as discussed further below), thereby ensuring that the germination releaser 170 contacts the germination container 160 with sufficient force to burst or break the germination container 160.

[0036] After the biological indicator 100 is inserted into the BI bay 375, the germinator release lever 401 is activated, thereby extending into the opening 121 of the biological indicator 100 and applying downward pressure to the internal components of the biological indicator 100. More specifically, the germinator release lever 401 is pressed downward (directly or via the sterilizer membrane 105) against the germinator releaser support 140, which is pushed downward toward the bottom 131. The germinator releaser support 140 bends downward, bringing the germinator releaser 170 into contact with the germinator container 160, thereby rupturing the germinator container 160 and releasing the germinator 165 into the BI housing 110. The germinating agent 165 flows downward toward the germinating agent pad 185, which captures (e.g., absorbs) the germinating agent 165, and the germinating agent 165 is delivered (e.g., wicked) through the germinating agent pad to the spore carrier 180. If the sterilization process is successful, the spores 181 in the spore carrier 180 die during the sterilization process, and DPA is released from the spores at this point. The DPA from these dead spores is bound by the luminosity component of the germinating agent, which may generate a static background level of DPA that can be detected by the BI reader 300. However, if any of the spores in the spore carrier remain viable after the completion of the sterilization process, these spores germinate upon contact with the germinating agent compound and release DPA upon germination. When DPA is released from these viable spores, it is bound by the luminosity component and detected by the BI reader 300 as a DPA signal exceeding the static background level (if such a background signal exists). The detection and differentiation of this DPA signal will be discussed in more detail below.

[0037] According to some embodiments, the biological indicator 100 may further include a germination pad 185. The germination pad 185 may be a wicking layer placed beneath the germination container 160. The germination pad 185 may include any material capable of wicking the germination (e.g., germination fluid) 165 discharged from the germination container 160 after the germination container 160 has burst. Not limited examples of suitable such wicking materials include cotton-based and cellulose-based materials, and any other wicking materials known to those skilled in the art.

[0038] When the germination container 160 bursts, the germination agent 165 released from the container 160 is transferred (or wicked) through the germination pad 185 to the spore carrier 180 located beneath the germination pad 185. The wicking (or transfer) function of the germination pad 185 is typically provided by the material of the germination pad 185, which can be any material suitable for wicking or transferring a fluid having the composition and properties of the germination solution, as generally described above, for example, by capillary action. Thus, the germination pad 185 provides relatively controlled delivery of the germination agent 165 to the spore carrier 180 through the germination pad 185.

[0039] The germination pad 185 can have any suitable shape and size, without limitation, as long as it can transfer the germination agent 165 to the spore carrier 180 through the pad. In some embodiments, for example, as shown in Figure 12, the germination pad 185 may have a substantially rectangular shape. As shown, the area (i.e., width × length) of the germination pad 185 may be larger than the area of ​​the spore carrier 180 so that the germination agent 165 is efficiently and reliably delivered to the spore carrier 180 in sufficient quantities. Furthermore, in some embodiments, the larger area of ​​the germination pad 185 allows the germination pad to hold any defective fragments of the damaged germination container 160 and prevent these fragments from contaminating the spore carrier 180. To facilitate this objective, in some embodiments, the germination pad 185 may also include projections on the substantially rectangular body configured to fit into channels 134 that hold the germination container 160. In embodiments where the shape of the germination pad 185 is not substantially rectangular, the germination pad 185 may have any other shape in which at least a portion extends into the channel 134.

[0040] The spore carrier 180 may include any support material capable of containing bacterial spores 181. The spores 181 may be any bacterial spores 181 suitable for use in determining the effectiveness of a sterilization process. The bacterial spores selected for determining the effectiveness of sterilization may vary depending on the type of sterilization process being tested. Typically, highly resistant bacterial species are selected because they are particularly difficult to kill, thus making the assessment of sterilization effectiveness more accurate. Traditionally, bacteria of the genera Geobacillus and Bacillus have been used because they are highly resistant to sterilization, such as steam sterilization. Therefore, the spores 181 in the spore carrier 180 may include bacteria of these genera, but this disclosure is not limited to these, and any bacterial spores known to be used for determining sterilization effectiveness, such as bacteria of the genus Clostridium, may be used non-limitingly.

[0041] The spores 181 can be attached to the spore carrier 180 by any suitable means and methods, without limitation. According to the embodiment, for example, the bacteria may be suspended in alcohol (e.g., ethanol or 40% ethanol), and the spores 181 may be attached to the carrier 180 by about 1.0 × 10⁻⁶. 7 Spores / 0.1 ml ~ approximately 3.0 × 10 7 The spore population may contain spores / 0.1 ml. The spores 181 may have a D value range of about 1.9 to about 2.1 minutes in steam at 121°C. According to the embodiment, about 200,000 spores 181 may be attached to the spore carrier 180, and in some embodiments, at least 100,000 spores 181 are attached to the spore carrier 180. According to the embodiment, the spores 181 are attached to the bottom surface of the spore carrier 180 (i.e., the surface of the spore carrier 180 facing the imaging window 190) so that the germination agent 165 permeates the spore carrier 180 before reaching the spores 181. This prevents the spores 181 from being over-immersed by the flow of the germination agent 165, which can affect the measurement by the BI reader 300.

[0042] To prevent spores 181 from passing through the spore carrier 180, and to allow the spore carrier 180 to withstand the high temperatures it receives during sterilization procedures (e.g., autoclaving), the spore carrier 180 may be formed from any suitable material having sufficient porosity and density. For example, the spore carrier 180 may have pore sizes of about 0.1 to about 0.8 μm, about 0.2 to about 0.4 μm, or about 0.3 μm. As will be further discussed below, according to the embodiment, the spore carrier 180 may be gray or black, thereby improving background correction during the examination of the biological indicator 100. The spore carrier 180 can be colored gray or black using any suitable dye, provided that the dye is not cytotoxic. Non-limiting examples of suitable spore carrier materials include polycellophane materials and cellophane-based materials such as polyester materials (e.g., polyethylene terephthalate).

[0043] Dipicolinic acid (DPA) was released from any of the spores 181 that died during the sterilization process. The DPA released by these dead spores 181 may diffuse into background DPA levels, which can be detected via the optical assembly of the BI reader 300 (further discussed below). In some embodiments, if early DPA measurements by the BI reader match expected levels based on a known bacterial spore population on the carrier, it indicates early that the spores in the BI were adequately exposed to the sterilizer during the sterilization process. Conversely, if early DPA measurements show the absence of DPA or DPA release below the expected threshold, it may indicate that the sterilization process failed or that the spores in the BI were not adequately exposed to the sterilizer. If any of the spores 181 remain viable after sterilization, the viable spores 181 will germinate upon exposure to the germination agent 165, releasing their own DPA, thereby producing a time-dependent DPA spike indicating spore germination (and thus spore retention) and sterilization failure. This will be discussed in more detail below.

[0044] The shape and size of the spore carrier 180 are not particularly limited and may be any shape and size suitable for holding a population of bacterial spores 181. However, as will be further discussed below, in some embodiments the spore carrier is no larger than the imaging window 190 so that the entire spore carrier can be imaged by the BI reader 300 and analyzed pixel by pixel. According to some embodiments, for example, the spore carrier 180 may typically have a disk shape in size and shape corresponding to the imaging window 190. According to some embodiments, the spores 181 are deposited on the spore carrier 180 so that the spores 181 are located at the center of the bottom opening 132, so the optical assembly of the BI reader 300 can be aligned to the center of the bottom opening 132 (and therefore to the position of the spores 181). The spores 181 are deposited on the spore carrier 180 according to any suitable method. For example, spores 181 can be deposited on the spore carrier 180 by applying a vacuum to extract the fluid while spores 181 suspended in a liquid are being deposited, thereby creating a dry deposit of spores 181 on the spore carrier 180. This reduces the likelihood of spores 181 moving on the spore carrier 180 after deposition. According to some embodiments, the spore carrier 180 can be pre-treated to improve its hydrophilicity. This allows the germination agent solution 165 to be delivered to the spores 181 more effectively, reducing the likelihood of artifact imaging. Examples of suitable hydrophilization treatments include, but are not limited to, UV exposure or plasma oxygenation.

[0045] As generally described above, the germinator container 160 contains the germinator (i.e., germinator solution or liquid) 165. The material and structure of the germinator container 160 are not particularly limited, as long as the germinator container 160 can hold the germinator solution 165 and withstand the conditions of the sterilization process (e.g., the high heat and steam of an autoclave), and the germinator releaser 170, operated by the leader 300, can break or rupture the germinator container 160. A person skilled in the art could select a suitable material for such a material, but glass is one non-limiting example.

[0046] According to some embodiments, the germinator container 160 may be a glass ampoule (ampule or ampoule). The germinator container 160 has any suitable thickness so that it contains the germinator 165 during a sterilization cycle (e.g., an autoclave cycle) and so that the germinator container 160 bursts when pressure is applied to it by the germinator releaser 170. According to one or more embodiments, the germinator releaser 170 may be a dowel made of metal or ceramic, but is not limited to these. To increase the likelihood that the germinator releaser 170 will burst the germinator container 160, the width direction X of the germinator releaser 170 (e.g., a dowel) BI The length is the width of the germination agent container 160 X BI It may be larger than the width. According to exemplary embodiments, the germination releaser 170 may have a spherical shape (such as BB) or any other suitable shape and density that allows the germination container 160 to burst.

[0047] According to one embodiment, the biological indicator 100 may further include gauze or other wrap placed around the germination container 160, which helps to collect fragments of the germination container 160 (e.g., glass fragments of the ampoule) generated by rupturing the germination container 160.

[0048] To prevent the germination solution 165 from being exposed to the sterile conditions of a sterilization process (e.g., from being exposed to steam generated in an autoclave), the germination solution 165 is contained in a germination container 160. The germination solution comprises at least a germination compound and a luminosity component, and may further contain a solvent, such as water. According to the embodiment, a surfactant such as sodium dodecyl sulfate (SDS) may be added to the germination solution 165, thereby further improving the hydrophilicity of the spore carrier 180 when it is exposed to the germination solution 165. The germination compound is not particularly limited and may be any compound capable of inducing the germination of bacterial spores 181 supported on the spore carrier 180. Those skilled in the art will be able to select a suitable such germination compound, for example, based on the type of bacterial spores supported on the spore carrier. Non-limiting examples of suitable germination compounds include L-alanine, potassium compounded with one or more monosaccharides, and compounds of valine and isoleucine.

[0049] The luminescence component, while not particularly limited, should be suitable for causing or enhancing the photoluminescence of DPA released by bacterial spores in the visible light range, thereby improving the detectability of the released DPA by the BI reader 300. Non-limiting examples of suitable such components include lanthanide complexes, e.g., complexes containing a lanthanide ion and a counterion. As will be understood by those skilled in the art, "lanthanide" includes elements 57-71 of the periodic table, namely La, Ce, Pr, Nd, Pm, Sm, Eu, Gb, Tb, Dy, Ho, Er, Tm, Yb, and Lu. In some embodiments, the lanthanide ion of the luminescence compound may include La, Ce, Eu, or Tb, e.g., Eu or Tb, and in some embodiments, the lanthanide ion may be Tb. Those skilled in the art can select anions suitable for lanthanide complexes, but some non-limiting examples include halides (e.g., chlorides, fluorides, bromides, or iodides). In some embodiments, for example, the anion may be a chloride. For example, in some embodiments, the luminosity component includes terbium chloride hexahydrate. Ponce et al.U.S. Patent No. 7,306,930 by Apparatus and titled "Method bacterial endospore quantification using lanthanide dipicolinate luminescence", U.S. Patent No. 7,608,419 by Ponce titled "Method and apparatus for detecting and quantifying bacterial spores on a surface", U.S. Patent No. 7,611,862 by Ponce titled "Method and apparatus for detecting and quantifying bacterial spores on a surface", U.S. Patent No. 9,469,866 by Ponce titled "Method and apparatus for detecting and quantifying bacterial spores on a surface", currently pending U.S. Patent Application No. 15 / 283,268 by Ponce titled "Method and apparatus for detecting and quantifying bacterial spores on a surface", U.S. Patent No. 9,816,126 by Ponce titled "Apparatus and U.S. Patent No. 7,563,615, titled “Method for automated monitoring of airborne bacterial spores”, now abandoned U.S. Patent Application No. 10 / 355,462, titled “Methods and apparatus for assays of bacterial spores”, U.S. Patent No. 8,173,359, titled “Methods and apparatus and assays of bacterial spores”, Ponce et al.Those skilled in the art will understand that methods, systems, and apparatus comprising germinator solution compositions disclosed in the now-abandoned U.S. Patent Application No. 13 / 437,899, entitled "Methods and apparatus for assays of bacterial spores" by Ponce et al., U.S. Patent No. 10,612,067, entitled "Methods and apparatus for assays of bacterial spores" by Ponce et al., and U.S. Patent Application No. 16 / 841,534, entitled "Methods and apparatus for assays of bacterial spores" by Ponce et al., each of these documents is incorporated herein by reference in their entirety, and that methods, systems, and apparatus comprising germinator solution compositions disclosed herein may also be utilized.

[0050] According to some embodiments, the biological indicator 100 may also include a sterilizer membrane 105 positioned between the raised portion 120a of the first outer casing 120 and the germinator releaser support 140. The sterilizer membrane 105 is permeable to the sterilizer (e.g., vapor permeable) to allow the sterilizer to access the interior of BI 100. The material of the sterilizer membrane 105 is not particularly limited as long as it is permeable to the sterilizer. Non-limiting examples of suitable sterilizer membrane materials include cellulose-based paper and kraft paper, e.g., 40-pound kraft paper. The sterilizer membrane 105 may have any suitable shape and size without limitation. In some embodiments, for example, the sterilizer membrane may be substantially circular and configured to fit inside the raised portion 120a of the first outer casing 120. According to some embodiments, the sterilizer membrane 105 may be omitted.

[0051] According to some embodiments, the biological indicator 100 may further include a secondary spore carrier and secondary spores at a second location away from the spore carrier 180. When the biological indicator 100 undergoes a sterilization process, the secondary spores are also exposed to the sterilizing agent. However, when the biological indicator 100 is activated by the BI reader 300, the secondary spores, unlike the spores 181 in the spore carrier 180, are not exposed to the germination agent 165 and can instead be used in a reference culture test to verify the results obtained from the BI reader 300. According to some embodiments, the secondary spores may be located outside the channel wall 135, for example, between the channel wall 135 and the side wall 136.

[0052] The biological indicator 100 according to the embodiment may be assembled as follows: First, a spore carrier 180 is placed inside the second outer casing 130 above the bottom opening 132, and spores 181 are deposited on the spore carrier 180. Next, an imaging window 190 is inserted into a window notch 133 of the second outer casing 130 and secured in place using a retaining ring 191. A germination pad 185 is placed on top of the spore carrier 180. The germination container 160 is placed inside the channel 134 above the germination pad 185 so that it remains inside the channel 134 and is angled downward toward the bottom 131 of the second outer casing 130. The germination releaser 170 is typically inserted into the germination releaser opening 144 before the germination releaser support 140 is inserted. The germination agent releaser support 140 is positioned on a portion of the germination agent container 160 above the imaging window 190, so that the extension portion 142a of the support leg 142 rests on the connecting portion 135a and the central leg 143 rests on another portion of the germination agent container 160. In some embodiments, the germination agent releaser 170 is independent, i.e., not attached to another component of the BI, and enjoys a certain amount of freedom within the BI. The sterilizer membrane 105 is positioned on the germination agent releaser support 140, and the first outer casing 120 is positioned on the sterilizer membrane 105, so that the raised portion 120a, sterilizer membrane 105, germination agent releaser support 140, germination agent releaser 170, germination agent container 160, spore carrier 180, and imaging window 190 are stacked (see, for example, Figure 12). Next, the groove 125 of the first outer casing 120 and the projection 139 of the second outer casing 130 (and vice versa) are fitted together, and the BI housing 110 is securely fixed. The process indicator 137b may be attached to the recess 137a before, during, or after the assembly of the BI housing 110, or it may be omitted.

[0053] Figures 13 to 18 show an alternative biological indicator 100' including a germination container (e.g., a sealed germination reservoir) 160' mounted on a germination releaser 170', where both the germination releaser 170' and the germination container 160' are housed within a second outer casing 130', and the aforementioned germination releaser support 140 is omitted. The various features of the biological indicator 100' are substantially the same as those previously described for the biological indicator 100. Therefore, further explanations therein may be omitted.

[0054] According to embodiments of the present disclosure, the germination container 160' may be mounted on top of the germination releaser 170'. When downward pressure is applied to the germination container 160', the germination releaser 170' is configured to puncture the barrier 161' of the germination container 160'.

[0055] The germinator container 160' may include an outer container 162' having a hollow interior for containing the germinator 165. The material of the outer container 162' is not particularly limited, as long as it can withstand sterile conditions and reliably contain the germinator solution 165. In some embodiments, the germinator container is made of a polymer material, a non-limiting example of which is polypropylene homopolymer. The outer container 162' is sealed with a barrier 161', which may be heat-sealed to the bottom of the outer container 162', for example, with aluminum foil. The barrier 161' is robust enough to eliminate the risk of frictional erosion at the contact surface between the barrier 161' and the release projection 171' of the germinator releaser 170', which will be discussed further below.

[0056] In the normal state, i.e., the non-activated state (i.e., when the germination container 160' is not pressed by the germination release lever 401), a gap (e.g., a gap of about 1 mm) may exist between the inner surface of the first outer casing 120 and the upper part 163' of the outer container 162'. The gap may allow the germination container 160' to move laterally within the BI housing 110. The upper part 163' of the outer container 162' may have a plurality of radial sterilizer release pathways (e.g., radial vapor release channels) 164', which facilitate the flow of sterilizer toward the interior of the BI housing 110 when the biological indicator 100 is being sterilized. The sterilizer release pathways 164' may also prevent the sterilizer membrane 105 from collapsing flat against the upper part 163' of the sterilizer container 160', thereby blocking the inflow of sterilizer or reducing the probability of sterilizer inflow. The sterilizer membrane 105 may be deformable to restrict access of the sterilizer to the inside of the BI housing 110, thereby increasing its resistance to the sterilizer.

[0057] When the germinator container 160' is pressed down by the germinator release lever 401 of the BI leader 300, the outer container 162' of the germinator container 160' is configured not to deform under pressure, and the entire germinator container 160' is positioned vertically from above toward the germinator releaser 170' (in the thickness direction Z). BI It is moved downward along the line, thereby breaking the seal of barrier 161' and the germination agent 165 is discharged by pressure. Pressurized discharge of germination agent 165 can provide repeatability and discharge rate for the operation of BI reader 300.

[0058] In some embodiments, as outlined above, the sterilizer opening 121' may be formed in a recess 137a of the second outer casing 130'. For example, the recess 137a may be defined by a short circumferential (or outer peripheral) side wall 137c of the projection 137, and the sterilizer opening 121' may be formed in the circumferential (or outer peripheral) side wall 137c to provide access to the sterilizer into the cavity, i.e., the interior, of the BI housing. As shown in Figure 14, the second outer casing 130' may further include a substantially cylindrical side wall 136' that houses the germinator container 160' and the germinator releaser 170'.

[0059] Referring to Figures 17-18, the germination agent releaser 170' may include a number of support legs 173' (e.g., three support legs 173') extending (e.g., radially) from the main body portion 172' of the germination agent releaser 170'. The support legs 173' may separate the main body portion 172' of the germination agent releaser 170' from the bottom 131 of the second outer shell 130. The main body portion 172' extends in the thickness direction Z BI It includes a release projection 171' that projects upward toward the germinator container 160'. The release projection 171' is configured to engage with the barrier 161' at the bottom of the germinator container 160'. When the germinator container 160' is pushed toward the main body portion 172', the release projection 171' is pressed against the barrier 161', breaking the seal formed by the barrier 161', thereby releasing the germinator 165. The main body portion 172' may include one or more release notches 174' on its outer circumference, which facilitate the flow of the germinator 165 beyond the germinator releaser 170' toward the germinator pad 185 when the barrier 161' of the germinator container 160' is ruptured.

[0060] According to the embodiment, the germinator releaser 170' does not have any sharp edges or pointed upward surfaces, including the releaser projection 171', so that the germinator container 160' can be safely placed on the main body 172' by gravity without prematurely bursting the germinator container 160' (for example, accidentally bursting it).

[0061] The material of the germination releaser is not particularly limited, as generally discussed above in relation to the germination releaser 170. In some embodiments, for example, the germination releaser 170' may be made of a polypropylene homopolymer.

[0062] A germination container 160' utilizing sealed foil may offer, for example, a relatively long storage life and durability during sterilization cycles. However, the foil barrier 161' may become ineffective during the drying time following a sterilization procedure (e.g., an autoclave cycle), and the barrier 161' may separate to some extent from the outer container 162'. The possibility of separation can be reduced by selecting an appropriate material for the barrier 161'.

[0063] For convenience, the following detailed description will refer to the biological indicator 100. However, it will be understood that other embodiments including the biological indicator 100' can be used in conjunction with the process challenge device 200 and the BI reader 300.

[0064] Referring to Figures 19 to 24, the biological indicator 100 may be inserted into the process challenge device (PCD) 200 before undergoing the sterilization process. In some embodiments, the PCD 200 may include a tray 210, a closure portion 240, a sterilizer sterilization integrator (or chemical integrator) 250, and the BI 100.

[0065] According to the embodiment, the tray 210 may define a first cavity 220, a second cavity 230, and a sterilizer access port 215. The first cavity 220 has a shape corresponding to the shape of the biological indicator 100 (i.e., the shape of the BI housing 110) and is configured to receive the biological indicator 100 in a "downward" configuration, i.e., the first outer casing 120 is in contact with the first cavity 220 and the bottom 131 faces away from the first cavity 220. The second cavity 230 is configured to receive the sterilizer sterilization integrator 250. The first cavity 220 and the second cavity 230 are in fluid communication with each other. In some embodiments, the sterilizer access port 215 is located in the central portion of the tray 210 between the first cavity 220 and the second cavity 230, but the disclosure is not limited thereto, and the sterilizer access port 215 may be located in any suitable position. The sterilizer access port 215 is also in fluid communication with the first cavity 220 and the second cavity 230.

[0066] The tray material is not particularly limited, as long as it can withstand the sterilization conditions the tray is subjected to. Some non-limiting examples of materials suitable for tray 210 include polymer materials resistant to sterilization conditions, such as polypropylene. Furthermore, the tray material may be at least partially transparent so that the sterilizer integrator 250 can be visually inspected while sealed.

[0067] During sterilization, it can be confirmed that the desired sterilization criteria are met by visually inspecting the tray 210 using a sterilization integrator 250. For example, the sterilization integrator 250 may be a PROPPER® VAPOR LINE® steam sterilization integrator, model number 26900925 (PROPPER® and VAPOR LINE® are registered trademarks of Propper Manufacturing Company, Inc.). However, the disclosure is not limited thereto, and any suitable means for providing instructions for introducing the sterilizer into the PCD may be used.

[0068] According to the embodiment, the sealing portion 240 may be a foil sheet or other material that can maintain a tight seal but may also be relatively easy to tear so that the biological indicator 100 can be removed after sterilization. After the sterilizer sterilization integrator 250 and the biological indicator 100 are inserted into the tray 210, the sealing portion 240 may be sealed to the tray 210 (e.g., by heat sealing).

[0069] The assembled PCD200, including the biological indicator 100, can be sterilized for testing. During sterilization, the sterilizing agent enters the PCD tray 210 via the sterilizing agent access port 215, travels through the tray to the BI housing 110, and enters the BI through the opening 121'. After the completion of sterilization, the biological indicator 100 can be removed from the PCD200 (i.e., from the tray 210) by destroying at least a portion of the closure portion 240 from the tray 210, or by other means of separation. The biological indicator 100 is then inserted into the BI reader 300, as will be discussed in more detail below, to determine the effectiveness of the sterilization.

[0070] Referring to Figures 25 to 28, an alternative tray 210' for PCD200' is shown. The various features of the alternative PCD are substantially the same as those described above with reference to PCD200. Therefore, further explanation regarding this may be omitted.

[0071] According to some embodiments, the tray 210' of the PCD includes a first cavity 220' and a tab 260'. As shown in Figures 25 and 26, the first cavity 220' has a shape corresponding to the shape of the biological indicator 100 (i.e., the shape of the BI housing 110) and is configured to receive the biological indicator 100 in a lateral configuration rather than a front-downward configuration of the first cavity 220 of the PCD 200. The tray 210' may have a smaller surface area than the tray 210 described above, and therefore the possibility of warping of the tray 210' after processing can be reduced.

[0072] According to the embodiment, the first cavity 220' can accommodate both the biological indicator 100 and the sterilizer sterilization integrator 250. The sterilizer sterilization integrator 250 is separated from the first cavity 220' by a tab 260' and held in place by the tab 260'. The tray 210' further includes a sterilizer access port 215', which is formed near the portion of the tray 210' to which the closure portion 240 is attached (see Figure 27).

[0073] The assembled PCD 200' containing the biological indicator 100 can be subjected to sterilization for testing. During sterilization, the sterilizing agent enters the PCD tray 210' via the sterilizing agent access port 215', proceeds through the tray 210' to the BI housing 110, and enters the BI through the opening 121'. After the completion of sterilization, the biological indicator 100 can be removed from the PCD 200' (i.e., from the tray 210') by destroying at least a portion of the closure portion 240 from the tray 210' or by other means of separation. The biological indicator 100 is then inserted into the BI reader 300, as will be discussed in more detail below, to determine the effectiveness of the sterilization.

[0074] According to embodiments of the present disclosure, the BI reader 300 determines the effectiveness of sterilization by measuring the level of DPA released by spores contained in the biological indicator 100 over time. The BI reader 300 includes various modular functional subassemblies integrated and interconnected within the BI reader 300 to determine the effectiveness of sterilization. The BI reader 300 may be operated using an external power source, such as a DC power supply.

[0075] According to embodiments of the present disclosure, the BI reader 300 includes a BI reader housing 301 including a front panel assembly 310 and a rear panel assembly 390, an optical assembly including a positioning assembly 340 and a camera assembly 360, and a heater block assembly 370. Referring to Figure 29, the front panel assembly 310 may include a front panel 311 including a display 312, one or more access doors 313, and corresponding access door releases 314. According to embodiments, the display 312 may be a touch panel display such as a thin-film transistor liquid crystal display module or an OLED display, and is configured to receive user input via a touchscreen and display information to the user. However, the present disclosure is not limited to such a touch panel display and may be any display capable of receiving user input (e.g., via tactile buttons that may be designed to allow the user to scroll through various menu options) and displaying necessary information (e.g., via a display window that is not a touchscreen). As will be further discussed below, the display 312 is connected to the display control board 315 (see Figure 32), which communicates with various other control boards within the BI reader 300 in order to operate the BI reader 300. The control boards of the BI reader 300 are collectively referred to herein as the control system.

[0076] Referring to Figures 30 to 31, the front panel 311 may define one or more door openings 316, one or more door release openings 317, and a display opening 322. As will be further discussed below, the size and shape of the door openings 316 are not particularly limited, as long as the BI 100 fits within the opening and the opening can accommodate the access door when the BI 100 is inserted. For example, in some embodiments, the door openings 316 may have a substantially rectangular shape when the front surface 311A ​​of the front panel 311 is viewed in plan and may have rounded corners.

[0077] As shown in Figures 30-31, the front panel 311 may include one or more chambers 326, each defining one or more door openings 316 corresponding to one or more door openings 316, and each of the one or more chambers 326 has a chamber opening 327 that is in fluid communication with its respective door opening 316. Each chamber 326 protrudes from the rear (or inner) surface 311B of the front panel 311 and is configured to guide the biological indicator 100 into the heater block assembly 370 when the biological indicator 100 is inserted into the door opening 316, as will be discussed further below. The chambers 326 may have any suitable shape, without limitation. According to the embodiment, the door opening 316 may have a height greater than the height of the biological indicator 100. In such embodiments, each chamber 326 may have an upward-sloping portion 326A (best shown in Figure 34), which extends from the rear surface 311B at the bottom of the door opening 316 and guides the biological indicator 100 toward the chamber opening 327 when it is inserted from below the chamber opening 327. Similarly, each chamber 326 may have a downward-sloping portion 326B (best shown in Figure 34), which extends from the rear surface 311B at the top of the door opening 316 and helps guide the biological indicator 100 toward the chamber opening 327 when it is inserted from above the chamber opening 327.

[0078] The size and shape of the door release opening 317 are not particularly limited and can have any suitable size and shape as long as they can accommodate the corresponding access door release 314. For example, in some embodiments, each of the door release openings 317 may be substantially oval and positioned adjacent to its corresponding door opening 316, so that each door opening 316 has a corresponding door release opening 317. In some embodiments, the door release openings 317 may be positioned below their corresponding door openings 316, but the disclosure is not limited thereto, and the door release openings can be positioned anywhere on the front panel 311. In fact, in some embodiments, the door release openings 317 may be positioned on the front panel in a location that does not correspond to or is not adjacent to a corresponding door opening. Each of the door release openings 317 may occupy a smaller area on the front panel than the area occupied by their corresponding door openings 316, but the disclosure is not limited thereto, and the door release openings 317 can have any suitable size and shape as described above.

[0079] Referring to Figure 32, the display 312 is received into the display aperture 322. According to the embodiment, the display 312 and the display aperture 322 may each have a substantially circular shape when viewed in plan. However, the disclosure is not limited thereto, and the display 312 and the display aperture 322 may have any suitable shape so that the display 312 can be received into the display aperture 322 and so that the display 312 can receive commands from the display control board 315 and display them to the user. For example, in some embodiments, the display 312 and the display aperture 322 may have a square, rectangular, oval, or any other geometric shape. The display 312 provides the user with information such as whether the BI reader 300 is ready to receive the BI 100, cycle history, date, time, and corresponding IP address.

[0080] The access door 313 is configured to fit inside the door opening 316 and to move between an open configuration (for receiving or removing BI 100) and a closed configuration (when the leader is active or in standby). Similarly, the access door release 314 is configured to fit inside the door release opening 317. As shown in Figures 31 and 34, the access door release 314 may be configured as a mechanical button that is pressed into the door release opening 317 to actuate the access door 313. However, the disclosure is not limited to such a configuration of the access door release 314, and in practice any mechanism for actinguate the access door 313 can be used. In some embodiments, for example, the access door release 314 may be electronic and actuate simply by touching the access door release 314 or by pressing a tactile button that triggers an associated control board to actuate the corresponding access door 313.

[0081] Referring to Figures 33 and 34, each access door 313 has an outer panel 313a that faces the user when the access door 313 is in a closed configuration, and an inner panel 313b that faces the inside of the BI reader 300 when the access door 313 is in a closed configuration. The access door 313 further includes a hook portion 313c at its top, which is connected to a pin 318 on the inner surface of the front panel 311. The hook portion 313c of the access door 313 is configured to pivot around the pin 318, and this configuration allows the access door 313 to move between an open configuration and a closed configuration when the access door 313 is unlocked and operated by the access door release 314. The front panel assembly 310 may further include a latch 320 and a latch spring 321 adjacent to the bottom of the door opening 316. The latch 320 is configured to engage with a latch plate 313d located at the bottom of the inner panel 313b of the access door 313. When the latch plate 313d and latch 320 engage, they lock the access door 313 in the closed position. As will be further discussed below, the access door release 314 is configured to release the latch plate 313d from the latch 320 by pressing the latch spring 321, thereby opening the access door 313.

[0082] The access door release 314 may be located directly below the access door 313 (or at any other location on the front panel 311). In some embodiments, the access door release 314 may be heat-crimped to a leaf spring that connects the access door release 314 to a latch spring 321. When the access door release 314 is activated (for example, pushed inward), the latch spring 321 is compressed, the latch 320 moves, and the latch plate 313d is released, so that the access door 313 can pivot around the pin 318 and move into an open configuration. According to embodiments, the front panel assembly 310 may further include one or more rotation dampers adjacent to the hook portion 313c to dampen the action of the torsion spring in the hook portion 313c during operation of the access door 313.

[0083] The access door 313 may include one or more sensors that provide the control system with signals, for example, whether the access door 313 is in an open or closed configuration, and whether the BI reader 300 is operational. For example, one or more sensors may include a door position sensor that provides a signal indicating that the access door 313 is in the closed position. Depending on the signals provided by one or more of the sensors, the BI reader 300 (via the control system) may, for example, prevent the release of the latch plate 313d while the BI reader 300 is operational, lock the door 313 in place, or, if the access door 313 is in an open configuration, prevent the BI reader 300 from starting a detection cycle (or cycle). As another example, each of the access doors 313 may include a round segment flag 328 that passes through a slot sensor 329 when the access door 313 is opened, thereby indicating whether the access door 313 is in an open or closed configuration.

[0084] In some embodiments, the front panel assembly 310 may further include a light source (e.g., a backlit LED) positioned around the periphery of the door release opening 317, so that when the light source is illuminated, it emits a ring of light surrounding the periphery of the door release 314. The light source may be configured to emit light of various colors, such as red, green, white, and yellow, to inform the user of the cycle status of the BI reader 300. For example, in some embodiments, the light source may emit green light to indicate that the bay 375 corresponding to the access door 313 associated with the door release 314 is empty (i.e., no BI 100 is inserted), red light when the bay 375 is occupied by the BI 100, white light to indicate that an inspection is in progress, and yellow light to indicate a warning signal. Alternatively or additionally, when the BI reader 300 is ready for use, the light sources of all door releases 314 may emit green light, and when the BI reader 300 is operating during a detection cycle, the light sources of all door releases 314 may emit red light. Alternatively or additionally, the light sources of individual door releases 314 may change from red to green upon completion of a detection cycle. In addition, the light sources (individually or all at once) may flash red to indicate a reader failure, or individually to indicate that the reader 300 has detected viable spores in the BI 100 inserted into the corresponding bay 375. As will be understood by those skilled in the art, the light sources associated with the door releases 314 may be programmed and controlled by the control system to indicate various system conditions by emitting light of any color, by changing from one color to another, or by flashing in any of a variety of patterns, without limiting them.

[0085] As briefly discussed above, the front panel assembly 310 forms part of the BI reader housing 301 and provides access to the heater block assembly 370 located inside the BI reader housing 301. Referring to Figures 35-36, the heater block assembly 370 may include a first heating plate (or lower heating plate) 371, a second heating plate (or upper heating plate) 372, and a heater cartridge 373. The second heating plate 372 is firmly mounted on the first heating plate 371 to establish strong thermal contact between the first heating plate 371 and the second heating plate 372. The heater cartridge 373 may be inserted into a heater channel 374 defined in the first heating plate 371. The heater cartridge 373 may be configured to heat the first heating plate 371 to approximately 56°C to approximately 62°C, more preferably to approximately 60°C, and may be configured to maintain the first heating plate 371 at a relatively constant temperature while the BI reader 300 is operating. For example, the heater cartridge 373 may be configured to maintain the temperature of the first heating plate 371 at a temperature of + / - 2°C from a predetermined temperature (e.g., 54°C to 64°C, depending on the predetermined temperature of the heater cartridge 373). It will be understood that the heater cartridge 373 is configured to heat the first heating plate 371 to a temperature lower than the maximum temperature at which the spores 181 are cultured. Therefore, the temperature at which the first heating plate 371 is heated may vary depending on the type of spore used in the BI 100 being tested, and thus the temperatures of the heater cartridge 373 and the first heating plate 371 are adjustable.

[0086] According to one embodiment, the heater block assembly 370 is configured to reach a set temperature, for example 60°C, within 15 minutes of operating the heater block assembly, and to maintain (or substantially maintain) the set temperature for an extended period (for example, during the operation of the BI reader 300).

[0087] The heater cartridge 373 is not particularly limited and can be any suitable heating element of any size and shape, as long as it fits into a dedicated space within the first heating plate 371 and can generate enough heat to maintain the first heating plate 371 and the second heating plate 372 at a selected temperature. In some embodiments, for example, the heater cartridge 373 may include a substantially cylindrical metal sheath (e.g., a 304 stainless steel sheath) operating at 12V / 24W, which is designed for high-temperature operation and is designed to transfer heat from the heater cartridge 373 to the first heating plate 371 and the second heating plate 372.

[0088] The first heating plate 371 and the second heating plate 372 are also not particularly limited and may be made of any suitable material and have any size and shape, as long as they fit into the designated space within the BI reader 300 and can maintain the selected temperature. For example, in some embodiments, the first heating plate 371 and the second heating plate 372 may be made of a metal with high thermal conductivity, such as an anodized metal such as aluminum, so that they can be efficiently heated by the heater cartridge 373. The heater block assembly 370 may be configured to maintain the same (or substantially the same) temperature throughout the first heating plate 371, so that each of the BI bays 375 (e.g., four BI bays 375) is maintained at substantially the same temperature. The term “substantially” as used herein is used as an approximation, not as a term of degree, and is intended to describe inherent deviations and inaccuracies in a particular measurement, observation, or characteristic. For example, as used herein, “substantially the same temperature” means that the BI bay 375 is maintained at a temperature that a person skilled in the art would understand to have no change, or only a negligible change, in the outcome of the detection cycle associated with a particular BI bay 375, but it should be noted that not all BI bays 375 can be maintained at exactly the same temperature.

[0089] According to the embodiment, one or more temperature sensors (e.g., thermistors) 376 may be attached to the first heating plate 371. The temperature sensors 376 may be spaced apart from each other to acquire temperature measurements at different locations on the first heating plate 371. The temperature sensors 376 monitor the temperature of the first heating plate 371 and output the temperature measurements (e.g., averaged) to a control system, which may adjust (or adjust) the heat output from the heating cartridge 373 as appropriate according to the temperature measurements. The temperature sensors 376 may also be used to determine when the first heating plate 371 has reached a set temperature (e.g., when the BI reader 300 is started), indicating that the BI reader 300 is ready to insert the biological indicator 100. For example, the control system receives temperature measurements from the temperature sensors 376 and displays information about those measurements on the display 312. Depending on the temperature measurements, the control system may activate one or more of the light sources associated with the door release 314. For example, when the BI reader 300 is started and when the temperature sensor(s) 376 receives a temperature reading indicating that the heater block 370 (or the first heating plate 371) has reached a threshold temperature (or set temperature), the control system may activate the light source and change it from red to green, and / or display a ready-to-use message on the display 312.

[0090] One or more BI bays 375 may be formed in the first heating plate 371. As discussed above, each of the BI bays 375 may have a shape substantially corresponding to the oval shape of the first end 100a of the biological indicator 100, so that the first end 100a of the biological indicator 100 can be securely inserted into the BI bay 375, for example by a slip fit. For example, each of the BI bays 375 may have a partially oval shape, as shown in Figures 36 to 39. The BI bay 375 may include a tongue 375a that fits into the insertion groove 138 of the BI 100, which further facilitates the precise alignment of the biological indicator 100 inside the BI bay 375.

[0091] The lower surface of the BI bay 375 includes an opening 375b, which is configured to align with the imaging window 190 when the biological indicator 100 is inserted into the BI bay 375. A BI window 379 may be positioned in the opening 375b. The BI window 379 may be transparent so that light can pass through it to the imaging window 190. For example, the BI window 379 may transmit UV light and, in some embodiments, may contain UV-grade fused silica quartz, which reduces the possibility of condensation forming on the BI window 379 during operation of the BI reader 300. The lower surface of the BI bay 375 is configured to contact the bottom 131 of the biological indicator 100 when the biological indicator 100 is inserted into the BI reader 300.

[0092] According to one embodiment, the first heating plate 371 may further include a movable rod 380 which contacts a movable BI presence flag 381 that communicates with a BI presence sensor 382. The movable rod 380 may be, for example, slidable and may be configured to partially extend within the BI bay 375 when there is no biological indicator 100 in the BI bay 375. When a biological indicator 100 is inserted into the BI bay 375, the biological indicator 100 moves the movable rod 380 in the direction of insertion of the biological indicator 100, causing the movable rod 380 to contact the movable BI presence flag 381, thereby triggering the BI presence sensor 382, ​​which then communicates with the control system of the BI reader 300.

[0093] According to the embodiment, the first heating plate 371 further defines one or more BI latch openings 383, each adjacent to each of the BI bays 375. The BI latch openings 383 are configured to accommodate BI latches 384 having ribs 387, the ribs 387 engaging with a portion of the insertion groove 138 of the biological indicator 100 (between the second end 100b of the biological indicator 100 and the projection 339) when the biological indicator 100 is fully inserted into the BI bay 375. The BI latches 384 are configured to facilitate precise alignment of the biological indicator 100 within the BI bay 375 to lock the biological indicator 100 in place and to reduce the possibility of the biological indicator 100 moving after insertion into the BI bay 375. As will be further discussed below, in this way the latch ensures that the BI100 is precisely positioned within the BI bay 375, that the bottom opening 132 is aligned with the imaging window 190, and that accurate measurements can be taken by the BI reader 300.

[0094] Referring to Figures 37 to 39, according to the embodiment, the BI latch 384 is movable within the BI latch opening 383 by rotating around the BI latch pin 386. As shown in Figure 37, before inserting the biological indicator 100, the rib 387 extends within the BI bay 375. During the insertion of the biological indicator 100, the first end 100a of the groove 138 of the biological indicator 100 contacts the rib 387, facilitating the guided insertion of the biological indicator 100 through contact between the rib 387 and the groove 138. When the insertion projection 138a of the BI 100 contacts the rib 387, the BI latch 384 pivots around the BI latch pin 386, moving away from the BI bay 375 and into the BI latch opening 383, thereby enabling the insertion of the biological indicator 100. As the biological indicator 100 is further inserted into the BI bay 375 and the insertion notch 138b of the biological indicator 100 is aligned with the rib 387, the BI latch 384 pivots back toward the BI bay 375, causing the rib 387 to engage with the insertion notch 138b of the biological indicator 100. This facilitates the alignment of the biological indicator 100 and reduces the possibility of the biological indicator 100 moving after insertion into the BI bay 375. In addition, the alignment assistance provided by the latch as described above further ensures the alignment of the bottom opening 132 in the BI bay 375 with the imaging window 190 as described above. The BI reader 300 may also include a BI presence sensor that detects when the biological indicator 100 has been inserted into the BI bay 375. The BI presence sensor may provide a signal to the control system of the BI reader 300 to prompt the user to close the access door 313.

[0095] The second heating plate 372 is positioned on top of the first heating plate 371. Referring to Figures 40-41, the second heating plate 372 includes one or more actuator channels 372a formed on its upper surface, each configured to receive a germination release lever 401 (see Figure 36). As will be discussed further below, the germination release levers 401 are configured to interact with biological indicators 100 inserted into their respective BI bays to activate germination releasers 170 within the BI 100. The second heating plate 372 further includes a plurality of upper BI bays 372b formed on its lower surface, which correspond to the BI bays 375 formed on the first heating plate 371.

[0096] According to some embodiments, the upper surface of the second heating plate 372 may also include one or more actuator brackets (e.g., plate guides) 378, each holding one or more actuators 400. In some embodiments, for example, the second heating plate 372 may include a plurality of separate actuator brackets 378, one for each actuator 400. However, according to some embodiments, the second heating plate 372 includes a monolithic (or otherwise connected) actuator bracket structure, in which the actuator brackets 378 are connected as a whole (or formed as a monolithic unit) to form a bracket plate that supports and holds all of the actuators 400. The actuator 400 may be paired with each solenoid 405, each pair which acts on one of the germinator release levers 401, which interact with the BI 100 (when the BI 100 is inserted into its respective BI bay) to act on the germinator releaser 170, thereby releasing the germinator 165 into the BI housing 110. The germinator release lever 401 may include a cam surface 402 and a push rod 403. As will be further discussed below, when actuated, the cam surface 402 rotates, and this rotation can be converted into a downward linear motion of the push rod 403 toward the biological indicator 100. The push rod 403 may have any suitable shape, e.g., substantially cylindrical, and is configured to be inserted into an opening 121 in the first outer casing 120 of the BI housing 110. As the push rod 403 moves downward into the opening 121, the germination agent releaser 170 is pressed downward against the germination agent releaser support 140, and then the germination agent releaser 170 comes into contact with the germination agent container 160, which causes the germination agent container 160 to burst and release the germination agent 165 from the germination agent container 160 onto the germination agent pad 185.

[0097] According to some embodiments, the actuator 400 controls the depth direction Y of the BI reader 300. RThe system may include shuttles 420 (see, for example, Figures 43-44) configured to move linearly along the Y-axis. Each shuttle 420 may be held by its respective actuator bracket 378 and connected to a shear wall (not shown) via a shuttle spring 410, and tension is applied to the shuttle spring 410 to hold the shuttle 420 in place when the BI reader 300 is not activated. According to some embodiments, each of the actuators 400 may be actuated by a corresponding solenoid 405. The solenoid 405 may actuate the shuttle 420 to move the shuttle 420 toward the front panel 311. For example, the central rod 406 of the solenoid 405 is located in the depth direction Y-axis of the BI reader 300. R The shuttle 420 is moved along the shuttle spring 410, overcoming the tension of the shuttle spring 410 and moving the shuttle 420 toward the front panel 311. The shuttle 420 may include a number of moving bearings 423 that function as wheels, which allows for relatively easy movement of the shuttle 420. As the shuttle 420 moves forward, the cam bearing 421 of the shuttle 420 interacts with the cam surface 402 of the germination release lever 401, acting the cam surface 402 clockwise. A wave spring 424 may surround the cam bearing 421, and when the cam bearing 421 is on the cam surface 402, it applies contact pressure to the cam surface 402. The push rod 403 then extends downward toward the BI bay 375 (into the opening 121 of the BI housing 110). After the inspection cycle is complete, the solenoid 405 retracts the central rod 406, the shuttle 420 is returned to its starting position by the shuttle spring 410, and the germination agent release lever 401 is disengaged from the biological indicator 100. The solenoid 405 can be any suitable solenoid capable of acting on the shuttle 420 as described herein, and is not particularly limited. In some embodiments, for example, the solenoid 405 may be a tubular push solenoid, for example, a push solenoid with a diameter of 1 inch × 2 inches.

[0098] The BI reader 300 may include one or more sensors that monitor the position of the shuttle 420, for example, a solenoid forward limit sensor that senses whether the solenoid 405 has been activated and the shuttle 420 has moved forward (e.g., whether the central rod 406 has been moved to the shuttle 420), and a solenoid backward limit sensor that senses whether the solenoid 405 has been deactivated and the shuttle 420 has moved backward (e.g., whether the central rod 406 has been moved backward). The solenoid forward limit sensor and the solenoid backward limit sensor may provide signals to the control system of the BI reader 300 to help determine whether the access door 313 of the BI bay 375 is locked or whether the BI bay 375 is accessible.

[0099] As shown in Figure 45, the shuttle 420 may include a door interlock spring 422 configured to engage with a retaining clip 319 adjacent to a pin 318 of the access door 313. For example, the door interlock spring 422 may interact with the retaining clip 319 while the shuttle 420 is moving forward toward the front panel 311 to prevent the access door 313 from rotating. When the shuttle 420 moves backward toward the rear panel 391, the door interlock spring 422 disengages from the retaining clip 319, thereby releasing the lock on the access door 313 at the hook portion 313c. The door interlock spring 422 provides an additional locking mechanism to prevent the access door 313 from moving during the inspection cycle of the BI reader 300.

[0100] The second heating plate 372 may further include a lever return spring 385 (see Figure 42), which is under tension, and when the actuator 400 is retracted, moves the germination agent release lever 401 back to its starting position (and moves the push rod 403 upward to exit the opening 121).

[0101] The shuttle 420 may further include one or more shuttle flags 425 and / or corresponding sensors, which are used to communicate the position of the shuttle 420 to the control system of the BI reader 300. Thus, the control system of the BI reader 300 may receive a signal from the shuttle flags / sensors 425 indicating that the shuttle 420 has moved, which indicates that a designated BI bay 375 has been activated, and the control system may then use the received signal to indicate that the BI bay 375 is operational and / or to activate the optical assembly.

[0102] Although actuator 400 is described herein in relation to shuttle 420, any suitable actuator or actuation mechanism can be used to enable the operation of the germination agent releaser 170 when BI 100 is inserted into BI bay 375, and it will be understood that this disclosure is not limited to the embodiments of the actuators specifically described.

[0103] According to the embodiment, the control system may include a lower BI sensor board 389 (shown in Figure 36), which may be mounted on an actuator bracket 378. The lower BI sensor board 389 may include sensors configured to detect the presence (or absence) of a biological indicator 100 in the BI bay 375 and / or the position of an actuator 400. The lower BI sensor board 389 may be spaced apart from the second heating plate 372 via the actuator bracket 378, thereby reducing the possibility of damage to the lower BI sensor board 389 while the second heating plate 372 is being heated (or maintained at a high temperature).

[0104] The heater block assembly 370 functions to heat the biological indicator 100 when the biological indicator 100 is inserted into the corresponding BI bay 375, thereby enabling the germination of spores 181. The heater block assembly 370 also provides a reference position for the biological indicator 100 to illuminate and image the spore imaging area inside the biological indicator 100. The heater block assembly 370 may include a self-calibration target 369 on the underside of the first heating plate 371, thereby enabling the calibration of the position adjustment assembly 340 (further discussed below) and the heater block assembly 370. According to some embodiments, the self-calibration target 369 may include a substrate (e.g., soda-lime glass) having a substantially square shape and offset angled parallel stripes, which can be used to calibrate the position adjustment assembly 340 in operation.

[0105] As shown in Figure 47, the heater block assembly 370 is located in the height direction Z of the BI reader 300 (for example, the BI reader 300). R The position adjustment assembly 340 is located at the top of the BI reader housing 301 (along the side), and at the bottom of the BI reader housing 301. However, this disclosure is not limited to this configuration, and any configuration of the subassemblies of the BI reader 300 (including the heater block assembly 370 and the position adjustment assembly 340) may be used as long as the BI reader can function as described herein.

[0106] Referring to Figures 48 and 49, the position adjustment assembly 340 includes a stepper motor 341 and a belt drive 342 that move the scan head assembly 350 below the BI bay 375. The stepper motor 341 may drive the belt drive 342. The stepper motor 341 may include any such motor capable of driving the belt drive 342, and is not particularly limited. In some embodiments, for example, the stepper motor 341 may include a high-torque motor with an integrated braking system, and the stepper motor 341 is mounted on the guide rail 343a and the BI leader 300 in the width direction X RAdjacent to it, it is mounted on deck 345. The belt drive 342 can also have any suitable structure, without being particularly limited. In some embodiments, for example, the belt drive 342 may include a drive pulley 342a, an idler pulley 342b, and a timing belt 342c. The timing belt 342c and the linear guide block 343 are in the width direction X R They may extend parallel to each other along the X-axis, and therefore, when the belt drive 342 is driven by the stepper motor 341, the linear guide block 343 moves in the width direction X-axis. R It moves along the guide rail 343a. According to some embodiments, the position adjustment assembly 340 may be configured to move the load by 60 mm per revolution, but the disclosure is not limited thereto. According to embodiments, the stepper motor 341 may include a magnetic brake (e.g., an integrated magnetic brake) which prevents (or reduces the possibility of) the movement of the linear guide block 343 (on which the scan head assembly 350 is positioned) when the BI reader 300 is not in use. According to embodiments, the timing belt 342c may be a circular toothed GT belt, but the disclosure is not limited thereto, and the timing belt 342c may have any suitable structure. When in use, the stepper motor 341 drives the drive pulley 342a to rotate, which in turn causes the timing belt 342c to rotate around the idler pulley 342b, and the linear guide block translates linearly along the guide rail 343a.

[0107] According to some embodiments, the position adjustment assembly 340 may further include one or more threshold sensors to restrict the movement of the scan head assembly 350 beyond one or more threshold limits. For example, in some embodiments, the position adjustment assembly 340 may include one sensor on the right side of the scan head assembly 340 and another sensor on the left side of the scan head assembly 340, thereby restricting the movement of the scan head assembly 340 in both directions along the belt drive 342.

[0108] The scan head assembly 350 is mounted on the linear guide block 343. Referring to Figure 49, the scan head assembly 350 includes an excitation source (e.g., an ultraviolet light-emitting diode (UV LED) excitation source) 351, a radiating lens (or excitation focusing lens) 352, a focusing lens 353, an excitation filter 354, and a first mirror 355. The radiating lens 352 and the focusing lens 353 may be bonded (e.g., permanently bonded) in place using an adhesive (e.g., a UV-curing adhesive) or any other suitable bonding means. The excitation source 351 is mounted on a bracket 356, which is fastened to the scan head body 357, for example, via screws. Thus, the excitation source 351 can be actively aligned with the scan head assembly 350. According to the embodiment, the first mirror 355 may be pressed against a reference using a spring (e.g., a urethane tube spring). The scan head assembly 350 may further include a scan head temperature sensor 358 (e.g., a thermistor) on the scan head body 357 to monitor the temperature of the scan head assembly 350.

[0109] The excitation source 351 may be configured to emit light in the UV wavelength range, i.e., a wavelength range of about 100 nm to about 400 nm. In some embodiments, for example, the excitation source 351 may be configured to emit light in the range of about 200 nm to about 300 nm, or about 250 nm to about 300 nm. For example, in some embodiments, the excitation source 351 may have a peak wavelength between about 270 nm and about 285 nm. The excitation filter 354 may have a center wavelength between about 270 nm and about 370 nm, for example, a center wavelength of about 330 nm, and may be positioned between the excitation source 351 and the imaging window 190 of the bioindicator 100. The light emitted from the excitation source 351 passes through the emission lens 352 and excitation filter 354 of the scan head assembly 350, and through the imaging window 190 of the BI 100 to reach the spores 181 of the spore carrier 180 in the biological indicator 100. Next, the light emitted by the spores 181 is reflected downwards, passing through the imaging window 190, the BI window 379 in the heater block assembly 370, and the focusing lens 353, and reaching the first mirror 355, which is positioned in the width direction XR The light is reflected along the direction Y to the second mirror (e.g., a reflector) 331, and then the second mirror 331 reflects the light in the depth direction Y. R The light is reflected along the line to the camera assembly 360, which then captures an image of the light.

[0110] More specifically, when the BI100 is inserted into the reader and the germination agent 165 is released within the BI100, the luminescence component (e.g., Tb ions) may bind to any DPA released from spores that died during the sterilization cycle. Furthermore, any spores that did not die during the sterilization process begin to germinate when they come into contact with the germination component (e.g., L-alanine) of the germination solution. This germination causes these spores to also release DPA, which then binds to the luminescence component and begins to emit light in response to light from the excitation chamber. Once the spores (or more precisely, the DPA luminescence complex) begin to emit light, this emission is reflected back through the imaging window 190 of the BI and reaches the camera assembly 360 along the optical path described above, where the camera assembly 360 captures an image of the emission. As will be further discussed below, the BI reader 300 analyzes the image captured by the camera assembly 360 to determine whether any of the spores 181 survived the sterilization cycle. Specifically, in some embodiments, the BI reader 300 detects the static background level of DPA from the luminescence returned by spores that died during the sterilization process. If any spores do not die during the sterilization process, these spores germinate upon contact with the germination solution 165, releasing DPA upon germination, which the BI reader 300 detects (if present) as a DPA signal exceeding the static background level. The BI reader 300 associates any DPA signal exceeding the static background level, or any DPA signal occurring after a predetermined period following BI activation, with a failure of the sterilization process.

[0111] The radiating lens 352 may be positioned between the excitation source 351 and the excitation filter 354 to disperse the light emitted from the excitation source 351. According to one embodiment, the radiating lens 352 may be a biconvex lens having a UV-AR coating. According to another embodiment, the radiating lens 352 may contain fused silica having a design wavelength between approximately 250 nm and approximately 425 nm. According to another embodiment, the radiating lens 352 may have a diameter of 12 mm, a focal length of 12 mm, and a back focal length of 9.25 mm.

[0112] According to one or more embodiments, the scan head assembly 350 is mounted on a linear guide block 343 that moves along a guide rail 343a aligned below the BI bay 375. The first mirror 355 is positioned on a bracket 357 and the first mirror 355 is positioned in the width direction X R The first mirror 355 is oriented (or aligned) to reflect light to the second mirror 331 of the mirror mount 330 (see, for example, Figures 47 and 50) along the same direction, thereby relaying collimated radiation from the scan head assembly 350 to the camera assembly 360. The camera assembly 360 is mounted to the bottom plate 302 of the BI reader housing 301, for example, via a mounting bracket. The camera assembly 360 is positioned at the pocket edge of the bottom plate 302. The scan head assembly 350, camera assembly 360, and optical path have been described above with reference to specific positional and directional optical paths, but it will be understood that these components may be alternatively positioned or arranged as long as the resulting optical path can deliver light from the scan head assembly 350 to the spore carrier 180 and return the emission from the spore carrier to the camera assembly 360.

[0113] Referring to Figure 47, in some embodiments, the linear guide block 343 is in the width direction X RA central panel 304 extending along the mirrors separates the mirror mount 330. The central panel 304 may define a first opening 304a aligned with the first mirror 355 and the second mirror 331, thereby allowing light to be reflected from the first mirror 355 to the second mirror 331. The central panel 304 may also define a second opening 304b for accommodating the timing belt 342c.

[0114] In some embodiments, the mirror mount 330 is fixed and may be positioned adjacent to the belt drive 342. The mirror mount 330 may be mounted on the deck 345 between the stepper motor 341 and the scan head assembly 350, for example between the stepper motor 341 and the central panel 304. According to the embodiment, the mirror mount 330 is positioned in the width direction X R Aligned with the scan head assembly 350 along the depth direction Y R It can be aligned with the camera assembly 360 along this line, and is therefore configured to reflect light from the scan head assembly 350 to the camera assembly 360.

[0115] The mirror mount 330 may have any suitable configuration so that it can receive a second mirror (rotating mirror) 331 and reflect light from the scan head assembly 350 to the camera assembly 360. For example, referring to Figure 50, the mirror mount 330 may include a base portion 332 and a bracket portion 333. The second mirror 331 is positioned in the height direction Z RThe base portion may have any suitable height to properly align with the scan head assembly 350 and deliver light to the camera assembly 360. The bracket portion 333 is configured to receive and hold the second mirror 331 and may have a pair of connected side walls 334, a substantially triangular top wall 336, and a base 335 on which the second mirror 331 rests. Each side wall 334 has an opening 334a, allowing light to pass through the opening 334a and reach the second mirror 331. The second mirror 331 may have a triangular prism shape (e.g., a right-angle mirror) and may include a silver-coated N-BK7 substrate, but is not limited to this disclosure, and the second mirror may have any suitable shape and structure.

[0116] Referring to Figures 51A, 51B, 52A, and 52B, the camera assembly 360 may include a camera 361, an optical lens 362, a filter 363, a camera fan 364, and a Peltier assembly 365 (for keeping the camera at a safe operating temperature). According to the embodiment, the camera assembly 360 may be positioned in a fixed position relative to the BI housing 301 and at the end of the aforementioned optical path to receive light emission from the spores. This configuration (i.e., a movable scan head assembly and a fixed camera assembly) makes it possible to analyze multiple bays using only one camera 361. However, the disclosure is not limited to this configuration, and the BI reader 300 may instead include a camera 361 for each BI bay 375. In such an embodiment, the BI reader 301 may also include a scan head assembly 350 for each BI bay, and both the scan head assembly 350 and the camera 361 may be fixed in a position below their respective BI bays 375. As can be understood, such a configuration of multiple cameras and multiple scan heads eliminates the need for the positioning assembly 340 and simplifies the optical path from the BI's imaging window 190 to the camera (as rotating optical elements (i.e., the first mirror, second mirror, and mirror mount) are no longer required), but the cost and size of the reader increase significantly.

[0117] According to exemplary embodiments, camera 361 may be a thermoelectric (TE) cooled charge-coupled device (CCD) camera. For example, in some embodiments, camera 361 may be a high-power camera, meaning that imaging rates (or frame frequencies) of about 5 kHz to about 10 kHz are possible, which enables effective imaging of the lifetime of the fluorescence signal of spores 181. Camera 361 may be configured to operate in time-gated mode, in which the long-lived emission of spores 181 excited by UV (e.g., UVC) radiation is captured by flashing UV light using an electronic shutter at periodic intervals to expose camera 361. Camera 361 may also be configured to operate in bright-vision imaging mode with variable exposure at frequencies of about 1 millisecond to 2000 milliseconds. An optical lens 362 is connected to camera 361. The optical lens 362 may have, for example, a focal length (FL) of 35 mm and a minimum working distance of 165 mm (f / 1.65) (i.e., a minimum working distance of 165 mm or more). Filter 363 is connected to lens 362. Filter 363 may be a bandpass filter, for example, a filter with a wavelength of approximately 534 nm to approximately 566 nm. In some embodiments, filter 363 may be a 550 nm bandpass filter.

[0118] Referring to Figures 52A to 52B, a Peltier assembly 365 may be attached to a camera 361, and a fan 364 may be attached to the Peltier assembly 365 to cool the camera 361. According to embodiments of the present disclosure, a camera guard 366 having a plurality of openings 367 may be attached to the fan 364 to reduce the possibility of any foreign matter entering the fan 364 and the Peltier assembly 365. To improve the performance of the fan 364, for example, to improve the heat transfer characteristics while the fan 364 is cooling the camera 361, the Peltier assembly 365 may be used. According to embodiments, the fan 364 may include a 40 × 40 × 20 24 VDC VAPO® 7.7 CFM fan (VAPO® is a registered trademark of Sunonwealth Electric Machine Industry, Co.). The guard 366 may be attached to the fan 364 and may be made of a durable material such as metal. For example, the guard 366 may include an aluminum alloy. The openings 367 may be formed radially; for example, the guard 366 may include 12 symmetrically rounded, wedge-shaped openings 367. However, it should be understood that the guard 366 is not limited thereto and may have any suitable configuration and any suitable number and shape of openings 367.

[0119] Referring to Figures 53-54, the BI reader housing 301 further includes an upper housing panel 306 on its upper part and a lower housing panel 307 at the bottom of the BI reader 300, below the lower plate 302. The upper housing panel 306 and the lower housing panel 307 are located in the height direction Z of the BI reader 300. R The upper housing panel 306 and the lower housing panel 307 may each have a substantially U-shaped outer form so as to extend along the curve and fit together to form the side surface of the BI reader housing 301.

[0120] The rear panel assembly 390 includes a rear panel 391, one or more axial fans 392, and an intake plenum 393. As shown in Figure 53, the rear panel 391 may have a number of perforations 394 through which air can flow. The shape and number of perforations 394 are not particularly limited and can be any shape and number as long as the perforations 394 allow a sufficient amount of air to flow through the rear panel 391. For example, in some embodiments, as shown in Figure 53, the perforations 394 may be formed in the shape of vertical slots so that the rear panel 391 resembles a grid. The axial fans 392 and the intake plenum 393 each allow air to be drawn into the BI reader 300, and the air can then be discharged through a vent below the front panel 311. For example, ambient air may be drawn into the BI reader 300 from the area behind the BI reader 300 through the rear panel assembly 390. This creates positive pressure inside the BI reader 300, which in turn expels warm air through the vents in the front panel assembly 310. For example, one of the axial fans 392 may be positioned directly adjacent to the camera 361, and the other two axial fans 392 may be positioned near the heater block assembly 370 to provide additional airflow. Thus, the amount of dust and other particles in the system can be reduced. Using the axial fans 392, the appropriate temperature of the BI reader 300 can be maintained for the components housed within the BI reader 300; for example, while the camera 361 is used in close proximity to the heater block assembly 370, the camera 361 can be maintained at an appropriate operating temperature.

[0121] Returning to Figure 47, according to the embodiment, the heater block assembly 370 is positioned on top of the linear guide block 343. As discussed above, the central panel 304 defines a second opening 304b for housing the timing belt 342c. The stepper motor 341 and drive pulley 342a may be positioned between the first side 303a of the BI reader housing 301 and the central panel 304, and the idler pulley 342b and linear guide block 343 (as well as the scan head assembly 350 mounted on the linear guide block 343) may be positioned between the second side 303b of the BI reader housing 301 and the central panel 304. The heater block assembly 370 may be supported between the second side 303b and the central panel 304 so as to be positioned on the same side as the linear guide block 343 on the BI reader 300. Both the camera assembly 360 and the mirror mount 330 are positioned between the first side 303a and the central panel 304.

[0122] According to the embodiment, the BI reader 300 includes four access doors 313, which are located in the width direction W of the BI reader 100. R Each of the four BI bays 375 is spaced apart from each other along the same line. Thus, the BI reader 300 can perform sterile effectiveness testing on the four biological indicators 100 in parallel (or simultaneously) during a single detection cycle of the BI reader 300.

[0123] Figure 55 is a block diagram of a control system according to various embodiments of the present disclosure. According to some embodiments, the control system 500 may be configured to operate the positioning assembly 340, heater block assembly 370, access door 313, and solenoid 405 of the BI reader 300, the excitation source 351, and scan head assembly 350, the display 312, etc. In some embodiments, the control system 500 may include a plurality of microcontrollers (or processors) running one or more modules configured to control different aspects of the BI reader 300. For example, one or more processors of the control system 500 may run a positioning assembly control module 510, a BI bay heater control module 520, a BI bay door and handler control module 530, a camera control module 540, an excitation control module 550, and a user interface control module 560. For example, in some embodiments, one or more controllers of the control system 500 may include a control processor 501, a bay processor 503, and a display processor 502, each of which may operate one or more of the following: a position adjustment assembly control module 510, a BI bay heater control module 520, a BI bay door and handler control module 530, a camera control module 540, an excitation control module 550, and a user interface control module 560.

[0124] In some embodiments, as generally shown in Figures 55 and 56, the positioning assembly control module 510 may be configured to control the positioning assembly 340. For example, the positioning assembly control module 510 may operate a stepper motor 341 and a belt drive 342. Furthermore, in some embodiments, the positioning assembly control module 510 may include lockout logic to prevent the positioning assembly 340 from advancing the scan head assembly 350 beyond a preset threshold limit (as further discussed below in relation to the bay processor and above in relation to the positioning assembly 340). As further discussed below, in some embodiments, the positioning assembly control module 510 may be operated by a control processor 501.

[0125] As shown in Figures 55 and 57, the BI bay heater control module 520 may, according to some embodiments, be configured to control the heater cartridge 373 and axial fan 392 of the heater block assembly 370, and to receive and process signals from the temperature sensor 376 of the heater block assembly 370. The BI bay heater control module 520 may further include logic to suppress the continued operation of the heater cartridge 373 if the temperature sensor(s) 376 record a temperature difference exceeding a preset threshold. The BI bay heater control module 520 may further include logic to perform a heater current monitor and suppress the continued operation of the heater if the heater current monitor records a current exceeding a preset threshold. As will be further discussed below, in some embodiments, the BI bay heater control module 520 may be performed by the bay processor 503.

[0126] In some embodiments, as shown in Figures 55 and 58, the BI bay door and handler control module 530 may be configured to control the solenoid 405. This module may further communicate with one or more sensors in each BI bay to detect various conditions. In some embodiments, the BI bay door and handler control module 530 may communicate with these sensors via one or more BI sensor boards (e.g., an upper BI sensor board 506 and a lower BI sensor board 389). For example, in some embodiments, the BI bay door and handler control module 530 may communicate with one or more of the following: a door position sensor, a solenoid forward limit sensor, a solenoid reverse limit sensor, or a BI presence sensor. Each of these sensors may be an infrared light interrupter, as discussed above, and each BI bay may contain one, any combination of two or more, or all of these sensors. In some embodiments, the BI bay door and handler module 530 may be performed by a bay processor 503.

[0127] As shown in Figures 55 and 59, the camera control module 540 may be configured to control the camera 361 according to the embodiment. For example, the camera control module 540 may be configured to operate the camera and receive and process images received by the camera 361. In some embodiments, the camera control module 540 may be performed by a control processor 501.

[0128] According to some embodiments, as shown in Figures 55 and 60, the excitation control module 550 may be configured to operate the excitation source 351. In some embodiments, the excitation control module 550 may be configured to receive input from the BI bay door and handler module 530 regarding a signal indicating, for example, which of the BI bays 375 is occupied by the BI 100. The excitation control module 550 may process this input to determine which of the BI bays 375 requires the excitation source to be activated and which of the BI bays 375 can be skipped in a particular process (for example, because a biological indicator 100 is not inserted in a particular BI bay 375). The excitation control module 550 may also operate a built-in mechanism to regulate the current of the excitation source 351, thereby maintaining current regulation throughout the excitation source 351 cycle (e.g., a PWM cycle). The excitation control module 550 may also be configured to control the timing of the excitation source activation and the length of its exposure, as well as the timing of the camera activation and the length of its exposure. In some embodiments, certain aspects of the excitation control module 550 may be performed by a control processor 501, and other aspects of the excitation control module 550 may be performed by a bay processor 503. However, the disclosure is not limited thereto, and it will be understood that the excitation control module 550 may be performed by a single processor (e.g., either the control processor 501 or the bay processor 503).

[0129] As shown in Figures 55 and 61, the user interface control module 560 may, in some embodiments, be configured to manage the interaction between the user and the display 312 (e.g., a touch panel). For example, the user interface control module 560 may be configured to receive and process user input and manage the display of information to the user on the display 312. In some embodiments, the user interface control module 560 may be performed by the display processor 502.

[0130] As described above, the control system may include multiple microcontrollers (or processors) to achieve control of each of these modules. For example, in some embodiments, the control system may include at least a control processor 501, a display processor 502, and a bay processor 503.

[0131] In some embodiments, for example, the control processor 501 may be configured to perform at least some of the positioning assembly control module 510, the camera control module 540, and the excitation control module 550. Using the control processor 501, which performs one or more of these modules, system monitoring, management of the camera 361 and the positioning assembly 340 (or more specifically, the stepper motor 341), operation of the camera 361 and the excitation source 351, processing and receiving of images captured by the camera 361, sequencing of spore detection inspections, and management of the light source in the door opening 316 (also referred to as the front panel LED board 504). To manage the light source in the door opening 316, the control processor 501 may be configured to communicate with the front panel LED (or light source) board, which includes the light source circuit.

[0132] Furthermore, in some embodiments, to control the positioning assembly 340, the control processor 501 may include lockout logic to prevent the positioning assembly 340 from advancing the scan head assembly 350 beyond a preset threshold limit. In such embodiments, the positioning assembly 340 may further include one or more threshold sensors (as generally discussed above) to restrict the movement of the scan head assembly 350 beyond one or more threshold limits. For example, in some embodiments, the positioning assembly 340 may include one sensor on the right side of the scan head assembly 340 and another sensor on the left side of the scan head assembly 340, thereby restricting the movement of the scan head assembly 340 in both directions along the belt drive 342.

[0133] In some embodiments, the BI reader 300 may include an external USB diagnostic port (not shown) and / or an Ethernet® port (similarly not shown). In embodiments including a USB diagnostic port, the control processor 501 may correspond to the USB diagnostic port and host a diagnostic graphical user interface (GUI). In embodiments including an Ethernet® port, the control processor 501 may be configured to facilitate the exchange of BI test data with an instrument tracking system (e.g., within a hospital) to comply with data management requirements.

[0134] Furthermore, in some embodiments, the display processor 502 may run a user interface control module 560. The display processor running this module may be configured to manage the display 312, including a touch panel (if used), and to receive and process user input. The display processor 502 may also support Ethernet® connectivity.

[0135] The bay processor 503 may, according to some embodiments, be configured to perform at least a portion of the BI bay heater control module 520 and the BI door and handler module 530. The bay processor 503 performing these modules (or portions thereof) may be configured to operate the solenoid 405, monitor and report the status (or configuration) of the access door 313, operate the heater cartridge 373, operate the axial flow fan 392, and manage specific functions of the excitation source 351. As shown in Figures 55 and 58, the bay processor 503 may also be configured to communicate with an upper BI sensor board 506 and a lower BI sensor board 389 having circuits for various BI sensors, including, for example, a slot sensor 329, a BI presence sensor 382, ​​and a shuttle sensor 425. As shown in Figures 55 and 57, the bay processor 503 may also be configured to communicate with the temperature sensor 376 of the heater block assembly 370 and process signals from these sensors to control the operation of the heater cartridge 373 and the axial fan 392 in order to maintain the temperature of the heater block assembly 370 within the temperature range discussed above.

[0136] It will be understood that the heater block assembly 370 and the optical assembly (i.e., the positioning assembly 340 and the camera assembly 360) are calibrated to each other to provide parallelism between each of the BI bays 375 and the scan head assembly 350, thereby ensuring a constant distance between the scan head assembly and each of the BI bays 375, and that the scan head assembly captures images of each BI bay 375 at its focal plane. It will be further understood that other configurations are possible. For example, if the camera assembly 360 is positioned so that it receives light sent by the BI 100 with minimal (or reduced) interference, the camera assembly 360 may be located elsewhere in the BI reader housing 301, and the mirror mount 330 may be moved or omitted. As another example, as described above, a separate camera assembly 360 and / or a separate excitation source 351 may be used for each BI bay 375. However, this disclosure also provides the BI reader 300 in a compact housing 301, which enables the use of fewer components and analysis of multiple BI bays 375 without using separate excitation and measurement equipment for each BI bay 375, and thus reduces the size and cost of the reader, as discussed above.

[0137] According to embodiments of the present disclosure, a method for detecting the sterilization effectiveness of a sterilization treatment includes utilizing the BI reader 300 and at least the BI 100 (and the PCD 200 in some embodiments) as discussed above. According to embodiments, for example, the biological indicator 100 may be examined and analyzed using the BI reader 300 to determine whether the sterilization treatment that the biological indicator 100 has undergone has been successful.

[0138] First, the user can activate the BI reader 300, for example, by pressing an on / off button or by interacting with the display 312 on the front panel 311 of the BI reader 300 (for example, to activate the BI reader 300). Upon receiving such user input, the control processor activates the heater cartridge 373 to begin heating the heater block assembly 370, for example, the first heating plate 371 and the second heating plate 372. When the first heating plate 371 and the second heating plate 372 reach a sufficient temperature, for example, 60 degrees Celsius, the temperature sensor(s) 376 of the heater block assembly 370 sends a signal to the control processor, which notifies the user that the BI reader 300 is ready for use. This notification may be made via information displayed on the display 312 and / or via a change in the light source associated with the access door release 314. For example, a change in light source could be a change from off to on (or vice versa), a change in color (such as red to green), or a change from on (or off) to blinking.

[0139] To perform a sterilization effectiveness test, the user may release the access door 313 by pressing (or otherwise activating) the access door release 314, exposing the door opening 316 and the chamber 326. The user may then insert the biological indicator 100 into the door opening 316 and pass the first end 100a of the biological indicator 100 through the chamber 326 and the chamber opening 327, thereby inserting the biological indicator 100 into the BI bay 375. As discussed above, when the first end 100a of the biological indicator 100 is inserted into the BI bay 375, the chamber 326 guides the biological indicator 100 into the chamber opening 327 and the BI bay 375. As the first end 100a of the biological indicator 100 continues to move within the BI bay 375, the insertion groove 138 contacts the BI latch 384, which then pivots around the BI latch pin 386 and moves into the BI latch opening 383, thereby enabling precise insertion of the biological indicator 100. When the biological indicator 100 is inserted into the BI bay 375, the BI latch 384 (e.g., rib 387) moves toward the biological indicator 100 via the insertion notch 138b, and the rib 387 moves into the insertion notch 138b, holding the biological indicator 100 in place.

[0140] One biological indicator 100 can be inserted into each BI bay 375. Thus, according to the embodiment, in the case of a BI reader 300 having four BI bays 375, four biological indicators 100 can be inspected in parallel or simultaneously. However, it is not necessary for all of the BI bays 375 of the BI reader 300 to be occupied in order to perform a detection cycle. Rather, any number of BI bays 375 may remain empty, and thus a detection cycle can be performed on only one BI 100 (leaving all other bays empty), or on any other number of BIs (up to the total number of bays in the reader). In such a case, the control system of the BI reader 300 receives a signal from a BI presence flag or sensor associated with each BI bay 375 and instructs the scan head assembly 350 to scan (or inspect) only the BI bays 375 occupied by BI 100. As a result, during the detection cycle, the scan head assembly 350 moves from bay to bay, but light is emitted from the excitation source only to the occupied BI bays 375. The scan head assembly 350 may stop in an empty bay, but the excitation source will not be activated in the empty bay 375. Alternatively, the control system may instruct the scan head assembly 350 to completely skip empty bays, so that the scan head assembly 350 does not stop in empty bays but only moves between occupied bays.

[0141] After the biological indicator 100 is inserted into the BI bay 375, the user may close the access doors 313, for example, by reactivating the access door release 314 or by manually lowering the access doors. After all access doors 313 are closed, the BI reader 300 may perform various software checks to ensure that the BI reader 300 is ready to perform the inspection. For example, utilizing the scan head assembly 350 and / or camera assembly 360, the control system may initiate a dust check to examine dust particles in the optical path, which is done by examining high-frequency noise in the field of view of the scan head assembly (e.g., the field of view defined by the BI window 379 of bay 375), where high-frequency noise indicates the presence of foreign matter in the optical path (e.g., between the BI window 379 of BI bay 375 and the imaging window 190 of BI 100). The BI reader 300 may also perform a condensation check to examine condensation formed on the BI window 379 during heating of the heater block assembly 370. The BI reader 300 may also perform a alignment check of the biological indicator 100 to ensure that the BI window 379 is precisely aligned with the BI bay 375, which is done, for example, by detecting Odin's cross of the bottom opening 132 to confirm that the biological indicator 100 is inserted within the acceptable range. The BI reader 300 may also perform a positioning check to ensure proper calibration of the scan head assembly 350 and the positioning assembly 340, as well as to ensure the correct distance between the scan head assembly 350 and the heater block assembly 370 (and therefore the BI window 379). To ensure the correct distance between the scan head assembly and the heater block assembly 370, the proper calibration of the scan head assembly 350 and the positioning assembly 340 may be confirmed using the self-calibration target 369, which is done by emitting light toward the self-calibration target 369 and measuring the pattern reflected from the calibration target 369.If any of these system checks fail, the control processor sends a fault or error message, which may include fault or error information displayed on the display 312 and / or via a change in the light source associated with the access door release 314. Furthermore, the BI reader 300 may include Z-focus adjustment via the optical assembly to estimate any deviation of the spore carrier 180 from the ideal focal plane (e.g., distance measurement) during the inspection cycle. Z-focus adjustment can be achieved using an electronically controlled micrometer together with the scan head assembly 350 so that the focal length of the focusing lens 353 can be adjusted within a range of + / -250 μm.

[0142] If all system checks pass, the control system (for example, via the control processor) activates the solenoid 405, which moves the central rod 406 of the solenoid 405 in the depth direction Y of the BI reader 300. R By pushing toward the shuttle 420 along the shuttle spring 410, the tension of the shuttle spring 410 is overcome, moving the shuttle 420 toward the front panel 311. Activation of the solenoid 405 locks the access door 313 in the closed position. As the shuttle 420 moves forward, the cam bearing 421 of the shuttle 420 interacts with the cam surface 402 of the germination release lever 401, acting the cam surface 402 clockwise. The push rod 403 then extends downward toward the BI bay 375 and into the opening 121 of the BI housing 110. Furthermore, the door interlock spring 422 of the shuttle 420 engages with the retaining clip 319 while the shuttle 420 is in motion, locking the access door 313 and preventing rotation.

[0143] The push rod 403 extends downward through the opening 121 of the BI housing 110, applying pressure to the germinator releaser 170, which in turn applies pressure to the germinator releaser support 140, which together with the germinator releaser 170 applies pressure to the germinator container 160, causing the germinator container 160 to burst and the germinator 165 contained within it to be released into the BI 100. The germinator 165 soaks into the germinator pad 185, which wicks the germinator through the germinator pad 185 to the spore carrier 180, which contains spores 181 on its underside. The germinator 165 is then wicked through the spore carrier 180 and reaches the spores on its underside.

[0144] As discussed above, when spores 181 in the spore carrier 180 die during sterilization, these spores release DPA. When these spores (or more precisely, the DPA released from these spores) come into contact with the germination solution 165, the luminescent component of the germination solution (e.g., Tb ions) may bind to the DPA to form a luminescent complex (e.g., Tb-DPA complex) that emits light when activated by UV light. After the germination solution 165 is released into the biological indicators 100, the control system may activate the optical assembly to generate, capture, and analyze images of the activity within each biological indicator 100. More specifically, the control system activates the positioning assembly to move the linear guide block 343 along the guide rail 343a and align the scan head assembly 350 below the first occupying BI bay 375. Next, the scan head assembly 350 emits light from the excitation source 351 toward the BI window 379, and this light passes through the emission lens 352, excitation filter 354, BI window 379, and imaging window 190 to reach the spores 181 in the biological indicator 100. This activates the photoluminescent complex, which begins to emit light and emit it back toward the imaging window, and the light passes along the aforementioned optical path (i.e., through the imaging window 190, the BI window 379 of the heater block assembly 370, and the focusing lens 353) to reach the first mirror 355, which is oriented in the width direction XR The light is reflected to the second mirror 331 along the Y direction, and then the second mirror 331 reflects the light in the depth direction Y. R The light is reflected along the path to camera assembly 360 and reaches camera 361. In some embodiments, camera 361 captures the luminescence produced by the dead spores as a bright, static background image. However, it should be understood that in some embodiments, the camera may not capture a background image.

[0145] As discussed above, if any of the spores 181 in the spore carrier 180 survive the sterilization cycle, these viable spores (or surviving spores) begin to germinate upon contact with the germinating agent (e.g., L-alanine) in the germinating agent solution 165. Upon germination, these surviving spores release DPA, which can then bind to the luminescence component of the germinating agent solution 165. The resulting DPA-luminescence complex then emits light when activated by UV light, as previously described in relation to dead spores. However, because the surviving spores release their DPA after germination, there is a time lapse and amplitude increase between the DPA signal received by the camera from dead spores and the DPA signal received by the camera from surviving spores. Therefore, if the camera detects a DPA signal exceeding the static background signal from dead spores, the control system returns a notification that the sterilization cycle has failed. This notification may be made via information displayed on display 312, and / or via a change in the light source associated with the access door release 314, and / or via an audio alarm.

[0146] The control system may also perform a check using the optical assembly to first detect whether the spore carrier 180 has been filled with the germination agent 165 due to its successful release, before executing the detection protocol. The optical assembly and control system perform this check by detecting and calculating the average intensity of the light emitted over time. For example, if the control system and optical assembly detect an intensity change above a certain threshold intensity ratio (e.g., about 110%) over time, the BI reader 300 records that the germination agent 165 has been successfully released and proceeds to the detection cycle. However, if the control system and optical assembly detect an intensity lower than the certain threshold intensity, the BI reader 300 records that the germination agent was not properly released and returns a fault or error. As discussed above, the fault or error may be indicated via information displayed on the display 312 and / or via changes in the light source associated with the access door release 314.

[0147] Furthermore, according to some embodiments, the threshold intensity used in this system inspection is based on the expected luminescence level of the spores 181 after the sterilization cycle. For example, the threshold intensity level of this inspection may be based on a percentage of the expected luminescence level, given the number and type of spores 181 in the spore carrier 180, assuming that all spores 181 died during the sterilization cycle (and thus released their DPA before the germination agent was released). Since the dead spores 181 are expected to luminescent and return an intensity signal relatively quickly upon contact with the germination agent 165, a luminescence intensity lower than the expected luminescence intensity may indicate that the germination agent 165 failed to be fully released and adequately fill the spore carrier 180. The threshold intensity (or threshold percentage of the expected luminescence intensity) is not particularly limited, as long as it is high enough to accurately determine whether the germination agent 165 was adequately released. In some embodiments, the threshold intensity may be set to 2000, i.e., outside the range of 0 to 65535 levels (for a 16-bit image). However, it will be understood that in some embodiments, the BI reader 300 does not detect or capture images of the background (or expected luminescence). In such embodiments, the threshold intensity of this inspection is set to 0, or this inspection is omitted.

[0148] Assuming the aforementioned germination agent release system inspection is passed, the control system instructs the BI reader 300 to continue the detection cycle. As discussed above, during the detection cycle, the optical assembly may emit light from the excitation source to the BI 100 in each occupancy bay and capture multiple images of the emission reflected through the imaging window 190 and the BI window 379. In some embodiments, to determine whether viable spores are present, the control system may generate a signal-to-noise ratio and compare any received emission signals with a static background image (if present). Specifically, if any spores 181 remain viable after sterilization, the first reflected emission may be below the expected threshold. The viable spores 181 then release their DPA after germination (i.e., some time after initial contact with the germination agent solution 165), at which point the newly released DPA combines with the luminescent component of the germination agent solution and emits light (activated by light from the excitation source). However, since this luminescence signal occurs after the time required for viable spores to germinate, this signal from viable spores does not appear until a static background image (if present) is established. Therefore, any signal from viable spores appears on top of the static background signal (if present) or as a time-dependent signal, and is identified by the control system as indicating viable spores, and thus as a sterilization failure.

[0149] To ensure accurate notification of sterilization success or failure, the entire spore carrier is evaluated over time to determine whether any spores remain. More specifically, while the scan head assembly 350 is positioned beneath the occupying BI bay 375, an excitation source emits light onto the spore carrier, and a camera captures multiple images of the entire spore carrier. These images captured by the camera assembly 360 are then sent to a control processor, which may analyze each image to compare, for example, the signal and noise (or background) of the returned image. In some embodiments, for example, the processor analyzes each of the captured images pixel by pixel. By analyzing the captured images pixel by pixel, it becomes possible to quantify the number of viable spores, thus providing a more accurate assessment of sterilization effectiveness. Specifically, when spores release DPA (by dying during the sterilization cycle or by germinating), DPA is usually released near the spores. However, the DPA released by dead spores 181 had sufficient time to diffuse across the spore carrier 180 until BI100 was processed. In contrast, the DPA released by viable spores 181 was released in real time (e.g., at 15-second intervals), and the DPA did not have sufficient time to diffuse from its pixel location. Therefore, the DPA signal from viable spores 181 appeared as a local intensity perturbation. Thus, the imaging and analysis protocols described herein allow imaging of individual spores in the spore carrier by viewing each pixel of the spore carrier 180. With a known number of pixels and a known number of spores 181 in the spore carrier 180, the number of viable spores 181 can be quantified by the control processor. For this reason, the number of pixels is not particularly limited, but in some embodiments, each image may contain 160 × 160 pixels.

[0150] As described above, if one or more spores remain viable after the sterilization cycle, they will generate an emission signal later than the BI startup or later than the signal generated by dead spores (which contribute to the background signal, if present). Therefore, in some embodiments, the optical assembly may be configured to capture images in each BI bay 375 at regular time intervals. The length of each interval is not particularly limited, but must be long enough to capture multiple images of the spore carriers during each stop period in each BI bay 375. For example, in some embodiments, each interval may be approximately 3 seconds long, so that when the scan head assembly 350 stops in the occupying bay 375, the scan head assembly 350 remains there for 3 seconds, emitting light onto the spore carriers and capturing images of the emission returned by the spore carriers, such images being an accumulation of photons captured by thousands of exposures. More specifically, in some embodiments, a linear guide block 343 (driven by a stepper motor and belt drive) is carried on a guide rail 343a until it reaches the first occupying bay 375. Upon reaching the first occupied bay 375, the linear guide block 343 stops there for a time interval (e.g., 3 seconds). After this time interval has elapsed, the linear guide block 343 moves again along the guide rail 343a until it reaches the next occupied bay 375, where it stops again for a time interval. This continues until all occupied bays 375 have been inspected by the scan head assembly. Once the scan head assembly 350 has reached the last occupied BI bay 375, the scan head assembly 350 returns to the first occupied bay 375 for a second time interval (usually equal in length to the first time interval, but may vary as needed), and then cycles through the remaining occupied bays again. The scan block assembly 350 can operate in this cyclical mode for any number of cycles, so that multiple illumination and image capture cycles are performed for each occupied bay 375 between each detection cycle of the BI reader 300.This time-gated imaging of the spore carrier allows the BI reader 300 and control processor to compare the time-gated images with each other to detect any emission signals that appear at different points in time or appear on top of the initially established background image (if any). Combined with pixel-by-pixel analysis of these images, as discussed above, the BI reader 300 can detect individual spores in the spore carrier and quantify the number of spores that remain viable after sterilization. It will be understood that the occupying bays 375 of the reader 300 can be analyzed in any order, including, for example, starting the scan head assembly cycle from the leftmost bay, the rightmost bay, or a bay somewhere in the middle.

[0151] According to the embodiment, the BI reader 300 can complete a full detection cycle (i.e., multiple cycles of the scan head assembly 350) in approximately 15 minutes or less. As discussed above, the positioning assembly 340 allows the scan head assembly 350 to move under various BI bays 375 at relatively short intervals, and can circulate through each of the BI bays 375 multiple times during a single detection cycle. Thus, multiple images are captured in each BI bay 375, providing a time-series image history. The BI reader 300 may be configured to improve the reliability of the BI reader 300 by analyzing the pattern of each biological indicator 100 over time and reducing the possibility of noise that would result in false negatives. According to the embodiment, if viable spores 181 are detected in one of the BI bays 375, the detection cycle may be stopped, or that BI bay 375 may be omitted while the inspection for viable spores 181 continues in the other BI bays 375.

[0152] After the detection cycle of the BI reader 300 is complete, the BI reader 300 may output a measurement or notification to the user indicating whether each of the biological indicators 100 that were examined did not contain viable spores. The measurement or notification output by the reader may be done via information displayed on the display 312 and / or via a change in the light source associated with the door release 314. For example, if the measurement or notification indicates that a BI 100 was positive in the viable spore test during the detection cycle (and therefore the sterilization cycle associated with that BI failed), the BI reader 300 may identify the bay number on the display next to a notification such as "Failure" or any other notification that tells the user that the sterilization cycle associated with the BI was unsuccessful. Additionally or alternatively, the light source corresponding to the BI bay may change, for example, from off to on (or vice versa), from one color to another (e.g., green to red, or vice versa), from on to blinking, etc. Additionally or alternatively, the BI reader 300 may include an audio alarm that emits a sound when viable spores are detected (or in the case of a system failure as discussed above). Similarly, if no viable spores are detected during the detection cycle (indicating a successful sterilization cycle), the reader 300 may identify the bay number on the display, alongside a notification such as "Pass" or any other notification informing the user that the sterilization cycle associated with the BI was successful. Additionally or alternatively, the light source corresponding to the BI bay may change, for example, from off to on (or vice versa), from one color to another (e.g., red to green, or vice versa), from steady to flashing, etc. Additionally or alternatively, the audio alarm may emit a clear sound indicating success (while another sound may be used to indicate a sterilization cycle failure, and yet another sound may be used to indicate a system failure).

[0153] Once the detection cycle is complete, the solenoid 405 is retracted, the shuttle 420 is released and retracts toward the rear panel 391, the door interlock spring 422 disengages from the retaining clip 319, and the access door 313 is unlocked at the hook portion 313c. As the shuttle 420 retracts, the sprout release lever 401 is released, and the push rod 403 retracts from the opening 121 of the biological indicator 100. The user can then release the access door 313 by pressing (or acting in another way) the access door release 314, allowing the biological indicator 100 to be removed. The secondary spore carrier can then be removed from the biological indicator 100, and a reference culture test may be performed using the secondary spore carrier, and the results returned by the BI reader 300 are verified (if necessary).

[0154] Exemplary Embodiments The exemplary embodiments described below are presented for illustrative purposes only and do not limit the scope or content of this disclosure.

[0155] Exemplary Embodiment 1: A biological indicator comprising: a biological indicator (BI) housing; a germination container within the BI housing for containing a germination agent composition before BI activation; an imaging window on a first surface of the BI housing; and a first spore carrier within the BI housing, the first spore carrier being substantially planar and having a first side and a second side, the first spore carrier carrying a first plurality of spores on its first side, wherein the first side of the first spore carrier and the first plurality of spores present therein are positioned relative to the imaging window and observed through the imaging window, and the germination agent composition is configured to come into contact with the first spore carrier and the first plurality of spores present therein after BI activation.

[0156] Exemplary Embodiment 2: The biological indicator according to Exemplary Embodiment 1, further comprising a sprouting pad configured to wick the sprouting composition after BI activation, wherein the sprouting pad is placed on the first spore carrier.

[0157] Exemplary Embodiment 3: A biological indicator according to any of the preceding exemplary embodiments, further comprising a sprouting pad configured to wick the sprouting composition after BI activation, wherein the sprouting pad is substantially planar and positioned adjacent to the second side of the first spore carrier.

[0158] Exemplary Embodiment 4: A biological indicator according to either Exemplary Embodiments 1 or 2, further comprising a germination pad configured to wick the germination composition after BI activation, wherein the germination pad is substantially planar and positioned adjacent to the second side of the first spore carrier, the first spore carrier positioned between the germination pad and the imaging window, and the first spore carrier, the germination pad, and the imaging window are all arranged in a configuration stacked as substantially parallel planes.

[0159] Exemplary Embodiment 5: A biological indicator according to any of the preceding exemplary embodiments, further comprising a germinator releaser configured to release the germinator composition from the germinator container when the BI is activated, wherein the germinator releaser is movable during the BI activation to release the germinator composition from the germinator container.

[0160] Exemplary Embodiment 6: A biological indicator according to any of Exemplary Embodiments 2 to 4, further comprising a germinator releaser configured to release the germinator composition from the germinator container, wherein the germinator releaser is movable toward the first spore carrier and the germinator pad during BI activation to release the germinator composition from the germinator container, and the germinator releaser is configured to press the germinator pad against the first spore carrier at least during BI activation. The germinator releaser may also be configured to press against the germinator pad, thereby pressing the germinator pad against the first spore carrier at least during BI activation, holding the first spore carrier relative to the imaging window, and / or holding the germinator pad and the first spore carrier in place at least during BI activation. In all embodiments, the germinator releaser may also remain pressed against the germinator pad after BI activation, including during image capture.

[0161] Exemplary Embodiment 7: A biological indicator according to any of the preceding exemplary embodiments, wherein the BI housing includes the germination container, the germination pad, and an opening aligned with the spore carrier, the opening being sealed to prevent the entry of sterilizer from entering the opening before BI activation, and the opening being configured to receive the germination release means of the BI reader during BI activation.

[0162] Exemplary Embodiment 8: A biological indicator comprising: a biological indicator (BI) housing; a germination container containing a germination composition within the BI housing; a germination releaser configured to release the germination composition from the germination container; a germination releaser support for supporting the germination releaser, wherein the germination releaser support is configured to bring the germination releaser into contact with the germination container when force is applied to the germination releaser support, the germination releaser, or the germination container; a first spore carrier carrying a first plurality of spores within the BI housing; and an imaging window on a first surface of the BI housing.

[0163] Exemplary Embodiment 9: The biological indicator according to Exemplary Embodiment 8, wherein the first spore carrier is substantially planar and has a first side and a second side, the first spore carrier carries the first plurality of spores on its first side, and the first side of the first spore carrier and the first plurality of spores present therein are positioned relative to the imaging window and observed through the imaging window.

[0164] Exemplary Embodiment 10: A biological indicator according to any one of Exemplary Embodiments 8 and 9, further comprising a sprout pad configured to wick the sprout composition after BI activation, wherein the sprout pad is substantially planar and positioned adjacent to the second side of the first spore carrier, so that the sprout pad, the first spore carrier, and the imaging window are in a stacked structure.

[0165] Exemplary Embodiment 11: A biological indicator according to any of the exemplary embodiments 8 to 10, wherein during BI activation, at least one of the germination agent releaser and the germination agent releaser support is movable toward the first spore carrier and the imaging window.

[0166] Exemplary Embodiment 12: A biological indicator according to any one of the exemplary embodiments 8, 9, and 11, further comprising a germination pad between the germination container and the spore carrier, wherein the germination pad comprises a wicking material and is configured to wick the germination from the germination container to the spore carrier.

[0167] Exemplary Embodiment 13: The biological indicator according to any of the preceding exemplary embodiments, wherein the BI housing defines an opening in the thickness direction of the biological indicator at a position above or adjacent to the germination releaser, and the opening, the germination container, the germination releaser, the spore carrier, and the imaging window are all stacked along the thickness direction.

[0168] Exemplary Embodiment 14: The biological indicator according to Exemplary Embodiment 13, further comprising a sealant material for sealing the opening before BI activation, wherein the sealant is configured to break down during BI activation.

[0169] Exemplary Embodiment 15: The biological indicator according to any one of the exemplary embodiments 13 and 14, wherein the BI housing further comprises a sterilizer entry port at a location different from the opening.

[0170] Exemplary Embodiment 16: The biological indicator according to Exemplary Embodiment 15, wherein the sterilizer entry port is located on the outer peripheral side wall of the BI housing.

[0171] Exemplary Embodiment 17: The biological indicator according to any one of the exemplary embodiments 15 and 16, further comprising a second spore carrier in fluid communication with the sterilizer entry port, wherein the second spore carrier carries a second plurality of spores.

[0172] Exemplary Embodiment 18: The germination container is a glass ampoule, a fragile ampoule, or an external container having a hollow interior sealed by a barrier, the biological indicator according to any of the preceding exemplary embodiments.

[0173] Exemplary Embodiment 19: A biological indicator according to any of the exemplary embodiments 5 to 18, wherein the germinator releaser support comprises a base defining a germinator releaser opening for receiving the germinator releaser, and a plurality of support legs supporting the base, the base being configured to be positioned on the germinator container, and at least some of the plurality of support legs having flexibility that allows the base to move toward the germinator container when downward pressure is applied to the base.

[0174] Exemplary Embodiment 20: The biological indicator according to any of the preceding exemplary embodiments, wherein the BI housing comprises a gripping portion and a raised portion, the gripping portion and the raised portion being adjacent to each other along the length dimension of the biological indicator, and the raised portion being configured to house at least a portion of the germination container, the germination releaser, the germination releaser support, and the first spore carrier.

[0175] Exemplary Embodiment 21: The biological indicator according to Exemplary Embodiment 20, wherein the raised portion of the BI housing has an opening of the BI housing positioned above the germination releaser along the thickness direction of the raised portion, and the opening, the germination container, the germination releaser, the spore carrier, and the imaging window are all stacked along the height direction within the raised portion.

[0176] Exemplary Embodiment 22: The biological indicator according to Exemplary Embodiment 21, wherein the raised portion further comprises a sealant material that seals the opening before BI activation, and the sealant is destroyed during BI activation.

[0177] Exemplary Embodiment 23: A biological indicator according to any one of the exemplary embodiments 20 to 22, further comprising a sterilizer entry port located in the gripping portion of the BI housing.

[0178] Exemplary Embodiment 24: The biological indicator according to Exemplary Embodiment 23, wherein the sterilizer entry port is located on the outer peripheral side wall of the gripping portion of the BI housing.

[0179] Exemplary Embodiment 25: A biological indicator according to any of the preceding exemplary embodiments, further comprising an imaging aperture on the first surface of the BI housing, wherein the imaging window is received in the imaging aperture.

[0180] Exemplary Embodiment 26: The biological indicator according to Exemplary Embodiment 25, wherein the imaging aperture has Odin's cross shape.

[0181] Exemplary Embodiment 27: The first spore carrier is a biological indicator according to any of the preceding exemplary embodiments, wherein the first spore carrier is gray or black.

[0182] Exemplary Embodiment 28: A biological indicator according to any of the exemplary embodiments 8 to 27, wherein the first plurality of spores are supported on the surface of the first spore carrier facing the imaging window.

[0183] Exemplary Embodiment 29: The germination agent releaser support is integrated with the germination agent releaser to form an integrated germination agent releaser having a plurality of rigid support legs and a plurality of releaser projections extending toward the barrier of the germination agent container, wherein when force is applied to the germination agent container and / or the integrated germination agent releaser, the plurality of releaser projections puncture the barrier of the germination agent container, as described in any of Exemplary Embodiments 8 to 28.

[0184] Exemplary Embodiment 30: A biological indicator according to any of Exemplary Embodiments 2-4 and 6-29, wherein the area of ​​the germination pad is larger than the area of ​​the first spore carrier.

[0185] Exemplary Embodiment 31: The size and shape of the first spore carrier is a biological indicator according to any of the preceding exemplary embodiments, which typically corresponds to the size and shape of the imaging window.

[0186] Exemplary Embodiment 32: The biological indicator according to Exemplary Embodiment 17, wherein the second spore carrier, which carries the second plurality of spores, is positioned within the BI housing such that the second spore carrier and the second plurality of spores are not exposed to the germination agent when the germination agent is released.

[0187] Exemplary Embodiment 33: A biological indicator according to any of the preceding exemplary embodiments, further comprising an insertion groove on a portion of the outer circumferential surface of the BI housing for engaging with a BI reader.

[0188] Exemplary Embodiment 34: The biological indicator according to Exemplary Embodiment 33, wherein the insertion groove comprises a first insertion projection and a second insertion projection at or near the first and second ends of the insertion groove, and the first and second insertion projections define a first insertion notch and a second insertion notch at the first and second ends of the insertion groove.

[0189] Exemplary Embodiment 35: A process challenge device for use in determining the effectiveness of a sterilization cycle, the process challenge device comprising: a tray defining a first cavity and a tab; a closure portion configured to be attached to the tray for sealing the first cavity; a sterilizing agent integrator or chemical indicator; and a sterilizing agent access port, wherein the first cavity is configured to receive a biological indicator as described in any of the preceding exemplary embodiments and the sterilizing agent integrator or the chemical indicator; and the tab is configured to separate the biological indicator from the sterilizing agent integrator or the chemical indicator.

[0190] Exemplary Embodiment 36: Apparatus for verifying the effectiveness of a sterilization cycle, the apparatus comprising a process challenge device having a sterilizer access port and one or more cavities in fluid communication with the sterilizer access port, the process challenge device further comprising a biological indicator as described in any of Exemplary Embodiments 1 to 34 and a chemical indicator or sterilizer sterilization integrator disposed in the one or more cavities.

[0191] Exemplary Embodiment 37: The apparatus according to Exemplary Embodiment 36, wherein the process challenge device comprises a tray and a closure portion, the one or more cavities being formed in the tray, the closure portion being attached to the tray to maintain a seal during the sterilization process and to hold the biological indicator and the chemical indicator or the sterilizing agent sterilization integrator within the tray, and the closure portion being configured to be broken or removed so that the biological indicator can be removed after the sterilization process.

[0192] Exemplary Embodiment 38: A biological indicator (BI) reader configured to determine the presence of viable spores in at least one biological indicator, the biological indicator reader comprising: a reader housing including a front panel assembly having at least one door opening and at least one access door, the access door being configured to move between an open configuration that exposes the door opening and a closed configuration that closes the door opening, the door opening being configured to receive the biological indicator through the door opening; a heater block assembly that at least partially defines at least one BI bay configured to receive the biological indicator and having a BI window; a germination starter disposed above the BI bay; an optical assembly including an excitation source configured to emit light through the BI window of the BI bay; and a camera assembly having a camera configured to capture an image passing through the BI window; and a controller configured to control the heater block assembly and the optical assembly and to collect information relating to the image collected by the camera.

[0193] Exemplary Embodiment 39: A biological indicator reader according to Exemplary Embodiment 38, further comprising an actuator configured to activate the germination activator, wherein the BI bay comprises an upper BI bay portion and a lower BI bay portion located below the upper BI bay portion, and the germination activator is configured to move through the upper BI bay toward the lower BI bay when activated.

[0194] Exemplary Embodiment 40: The biological indicator reader according to Exemplary Embodiment 39, wherein the actuator is actuated by a solenoid valve.

[0195] Exemplary Embodiment 41: A biological indicator reader according to any of the exemplary embodiments 38 to 40, further comprising: a scan head assembly disposed below the heater block assembly, the scan head assembly including the excitation source, a scan head body, and a first mirror; and a mirror mount located between the scan head assembly and the camera, the mirror mount having a second mirror that reflects light from the scan head assembly to the camera.

[0196] Exemplary Embodiment 42: The biological indicator reader according to Exemplary Embodiment 41, wherein the scan head assembly further comprises a radiating lens above the excitation source and a focusing lens above the first mirror.

[0197] Exemplary Embodiment 43: A biological indicator reader according to any of the exemplary embodiments 38 to 42, wherein the excitation source comprises an ultraviolet light-emitting diode.

[0198] Exemplary Embodiment 44: The biological indicator reader according to any one of the exemplary embodiments 41 and 42, wherein the at least one BI bay comprises a plurality of BI bays, the biological indicator reader further comprises a positioning assembly, the positioning assembly comprises a stepper motor, a belt drive, and a linear guide block, and the scan head assembly is mounted on the linear guide block and configured to move under the plurality of BI bays.

[0199] Exemplary Embodiment 45: The biological indicator reader according to any of the exemplary embodiments 38 to 44, wherein the at least one BI bay comprises a plurality of BI bays, each BI bay having its own BI window, and the biological indicator reader further comprises a positioning assembly, the positioning assembly comprising the excitation source, configured to move along the plurality of BI bays, and the excitation source can be positioned to sequentially emit light through the respective BI windows of the plurality of BI bays.

[0200] Exemplary Embodiment 46: A biological indicator reader according to any of the exemplary embodiments 38 to 46, further comprising a rear panel assembly including a rear panel, an axial fan, and an intake plenum.

[0201] Exemplary Embodiment 47: A biological indicator reader according to any of the exemplary embodiments 38 to 46, wherein the front panel assembly further includes a latch, and the access door includes a latch plate, and when the access door is in the closed position, the latch of the front panel assembly and the latch plate of the access door are configured to engage and lock the access door.

[0202] Exemplary Embodiment 48: A biological indicator reader according to any of the exemplary embodiments 38 to 46, further comprising an access door lock configured to lock the access door when the access door is in the closed position.

[0203] Exemplary Embodiment 49: A biological indicator reader according to Exemplary Embodiment 47, further comprising an access door release, wherein when the access door release is activated, the latch plate of the access door is released from the latch of the front panel assembly, and the access door opens.

[0204] Exemplary Embodiment 50: The biological indicator reader according to Exemplary Embodiment 48, further comprising an access door release, wherein when the access door release is activated, the access door lock is released and the access door opens.

[0205] Exemplary Embodiment 51: The biological indicator reader according to Exemplary Embodiment 49, wherein the access door release communicates with a latch spring of the front panel assembly, and the operation of the access door release compresses the latch spring, resulting in the movement of the latch, the release of the latch plate, and the opening of the access door.

[0206] Exemplary Embodiment 52: The biological indicator reader according to Exemplary Embodiment 49, wherein the access door release is connected via a leaf spring to a latch spring of the front panel assembly, and the operation of the access door release compresses the latch spring, causing the latch to move, the latch plate to be released, and the access door to open.

[0207] Exemplary Embodiment 53: A biological indicator reader according to any of the exemplary embodiments 38 to 52, further comprising a door position sensor configured to provide the controller with a signal indicating whether the access door is in the open configuration or the closed configuration.

[0208] Exemplary Embodiment 54: A biological indicator reader according to any of the exemplary embodiments 38 to 52, wherein the controller is configured to prevent the opening of the access doors when all of the access doors are in the closed configuration and the biological indicator reader is activated.

[0209] Exemplary Embodiment 55: A biological indicator reader according to any of the exemplary embodiments 38 to 54, wherein the controller is configured to prohibit the operation of the biological indicator reader when all of the at least one access doors are in the open configuration.

[0210] Exemplary Embodiment 56: A biological indicator reader according to any of the exemplary embodiments 38 to 55, further comprising one or more temperature sensors configured to sense the temperature of the heater block assembly, the one or more temperature sensors outputting temperature measurements to the controller, and in accordance with the temperature measurements, the controller adjusting the heat output from one or more heating elements of the heater block assembly.

[0211] Exemplary Embodiment 57: A biological indicator reader according to Exemplary Embodiment 56, further comprising a display, wherein one or more temperature sensors output temperature measurements to the controller, and the controller displays information regarding the temperature measurements on the display in accordance with the temperature measurements.

[0212] Exemplary Embodiment 58: A biological indicator reader according to any of the exemplary embodiments 38 to 57, wherein when the biological indicator is inserted into the BI bay, the BI window of the BI bay is configured to align with the imaging window of the biological indicator.

[0213] Exemplary Embodiment 59: A biological indicator reader according to any of the exemplary embodiments 38 to 58, wherein the BI window comprises UV-grade fused silica quartz.

[0214] Exemplary Embodiment 60: A biological indicator reader according to any of the exemplary embodiments 38 to 59, further comprising a BI presence sensor configured to communicate the presence of a BI in the BI bay to the controller.

[0215] Exemplary Embodiment 61: A biological indicator reader according to any of the exemplary embodiments 38 to 60, wherein the BI bay comprises a BI latch configured to engage with a portion of the insertion groove of the biological indicator when the biological indicator is inserted into the BI bay, thereby holding the biological indicator in place.

[0216] Exemplary Embodiment 62: A biological indicator reader according to any of the exemplary embodiments 38 to 61, wherein when the BI is inserted into the BI bay, the germination release lever is configured to apply downward pressure to the biological indicator and activate the BI.

[0217] Exemplary Embodiment 63: A biological indicator reader according to any of the exemplary embodiments 38 to 62, wherein the germination activator is configured to enter the biological indicator and release the germination solution within the biological indicator.

[0218] Exemplary Embodiment 64: A biological indicator reader according to any of the exemplary embodiments 38 to 63, further comprising a germination starter actuator configured to activate the germination starter.

[0219] Exemplary Embodiment 65: The biological indicator reader according to Exemplary Embodiment 64, wherein when the germination activator is activated, the germination activator actuator is configured to prevent the access door from moving to an open configuration.

[0220] Exemplary Embodiment 66: A biological indicator reader according to any of the exemplary embodiments 38 to 65, further comprising an access door lock configured to prevent the access door from moving to the open configuration when the germination agent activator is activated.

[0221] Exemplary Embodiment 67: A biological indicator reader according to any of the exemplary embodiments 38 to 66, further comprising a germination starter position sensor configured to communicate the position of the germination starter to the controller.

[0222] Exemplary Embodiment 68: The camera assembly is positioned in a fixed location, and is a biological indicator reader according to any of the exemplary embodiments 38 to 67.

[0223] Exemplary Embodiment 69: The biological indicator reader according to Exemplary Embodiment 45, wherein the camera assembly is positioned in a fixed position, and the position adjustment assembly further comprises a mirror, the mirror being movable together with the position adjustment assembly.

[0224] Exemplary Embodiment 70: A biological indicator reader according to any of the exemplary embodiments 38 to 69, wherein the camera includes a thermoelectric (TE) cooled charge-coupled device (CCD) camera.

[0225] Exemplary Embodiment 71: A biological indicator reader according to any of the exemplary embodiments 38 to 70, wherein the camera is configured to operate in time-gate mode.

[0226] Exemplary Embodiment 72: A biological indicator (BI) reader configured to determine the presence of viable spores in a plurality of biological indicators using time-gated imaging, wherein the biological indicator reader comprises: a reader housing having a plurality of openings, through which the biological indicators are received; a plurality of BI bays, each of which is accessible through one of the plurality of openings, and each of which further has a BI window configured to allow light to and from the BI bay; and a plurality of germination starters, each of which has a A biological indicator reader comprising: a plurality of germination starters, each positioned in one of a plurality of BI bays and configured to activate one of the biological indicators when the biological indicator is present in each of the BI bays; an optical assembly including a movable excitation source configured to sequentially emit light through the BI window of the BI bay and a camera assembly configured to capture images passing through the BI window of the BI bay and configured to operate in a time-gated mode; and a controller configured to control the optical assembly and to collect information relating to the images collected by the camera.

[0227] Exemplary Embodiment 73: The biological indicator reader according to Exemplary Embodiment 72, wherein the controller is configured to move the excitation source between the plurality of BI bays, to cause the excitation source to emit light through the BI window of the BI bay which is identified as occupied by a BI, and to prevent the excitation source from emitting light through the BI window of the BI bay which is identified as empty.

[0228] Exemplary Embodiment 74: The plurality of germination agent activators comprises at least one of a plurality of germination agent release levers and a plurality of push rods, and the biological indicator reader according to any one of Exemplary Embodiments 72 and 73.

[0229] Exemplary Embodiment 75: Further comprising a movable position adjustment assembly, the position adjustment assembly comprising a mirror and the excitation source, the position adjustment assembly being configured to move along the plurality of BI bays, and the excitation source can be arranged to emit light sequentially through the respective BI windows of the plurality of BI bays, and the mirror can be arranged to receive light sequentially from the respective BI windows of the BI bays, and the biological indicator reader according to any one of Exemplary Embodiments 72 to 74.

[0230] Exemplary Embodiment 76: When the biological indicator is inserted into each of the BI bays, each of the germination agent activators is configured to activate the biological indicator by applying pressure to each one of the plurality of biological indicators to cause rupture of the germination agent container within each of the biological indicators.

[0231] Exemplary Embodiment 77: Each of the germination agent activators is configured to enter each of the biological indicator readers of the plurality of biological indicators and release the germination agent solution within each of the biological indicators, and the biological indicator reader according to any one of Exemplary Embodiments 72 to 76.

[0232] Exemplary Embodiment 78: A method for determining the effectiveness of a sterilization process, the method comprising: providing a biological indicator, the biological indicator having been previously subjected to a sterilization process, the biological indicator comprising a plurality of spores deposited on a spore carrier and a germination agent container containing a germination agent composition; heating the biological indicator to the culture temperature of the spores; discharging the germination agent composition from the germination agent container into the biological indicator so that the germination agent composition interacts with the plurality of spores on the spore carrier; emitting light from an excitation source through a window of the biological indicator; capturing a plurality of images over time using a camera from the light radiated back through the window of the biological indicator; comparing the plurality of images with respect to time to identify any change in the intensity of the light radiated back through the window of the biological indicator, wherein the change in the intensity of the light radiated back through the window of the biological indicator over time indicates a failure of the sterilization process; and the method comprising the above steps.

[0233] Exemplary Embodiment 79: The biological indicator comprises a plurality of biological indicators, and the method further comprises moving the excitation source between each of the plurality of biological indicators, preferably at regular time intervals, according to the method described in Exemplary Embodiment 78.

[0234] Exemplary Embodiment 80: The comparing the plurality of images with respect to time comprises comparing the images pixel by pixel, according to the method described in any one of Exemplary Embodiments 78 and 79.

[0235] Exemplary Embodiment 81: The method according to any one of Exemplary Embodiments 78 to 80 further comprises subjecting the biological indicator to the sterilization process before discharging the germination agent composition from the germination agent container.

[0236] Exemplary Embodiment 82: The method according to any of the exemplary embodiments 78 to 81, wherein the spore carrier is substantially planar and carries the plurality of spores on a first side thereof, the first side of the spore carrier is preferably positioned relative to the window of the biological indicator, and the emission of light from the excitation source through the window of the biological indicator is equivalent to emitting light relative to the first side of the spore carrier.

[0237] Exemplary Embodiment 83: The method according to any of the exemplary embodiments 78 to 82, wherein the spore carrier is substantially planar and carries the plurality of spores on a first side thereof, the first side of the spore carrier is preferably positioned relative to the window of the biological indicator, and capturing the plurality of images over time includes capturing the plurality of images from light emitted by the first side of the spore carrier.

[0238] Exemplary Embodiment 84: The method of any of the exemplary embodiments 78 to 83, wherein the biological indicator comprises a plurality of biological indicators, and the method further comprises: arranging each of the plurality of biological indicators in each BI bay of a BI reader; moving the excitation source between the biological indicators in the BI bays; and identifying that the excitation source has been placed in the BI bays, and in accordance with the identification, (i) emitting light from the excitation source; and (ii) receiving and processing the plurality of images from the biological indicators placed in the BI bays.

[0239] Exemplary Embodiment 85: The method according to any of the exemplary embodiments 78-84, wherein the biological indicator is located in one of a plurality of BI bays of a BI reader, and the method comprises moving the excitation source between the plurality of BI bays to activate the excitation source multiple times under each BI bay during a single cycle of the system, with the camera capturing an image each time the excitation source is activated.

[0240] Exemplary Embodiment 86: The method according to any of the exemplary embodiments 78 to 85, wherein capturing the plurality of images comprises capturing a plurality of images substantially of the entire spore carrier.

[0241] Exemplary Embodiment 87: The method according to any of the exemplary embodiments 78 to 86, wherein the spore carrier is substantially planar and carries the plurality of spores on a first side thereof, and the comparison of the plurality of images comprises comparing the plurality of images on the first side of the spore carrier pixel by pixel.

[0242] Exemplary Embodiment 88: The method according to any one of the exemplary embodiments 78 to 86, further comprising placing the biological indicator in the BI bay of a BI reader, and releasing the germination composition from the germination container, preferably by having a portion of the BI reader enter the biological indicator, thereby applying pressure from the BI reader to break the germination container and release the germination composition.

[0243] Exemplary Embodiment 89: The method according to any of the exemplary embodiments 78 to 85, wherein the biological indicator comprises a germination pad, the spore carrier is substantially planar, the germination pad, the spore carrier, and the window are in a stacked configuration, and the method further comprises placing the biological indicator on a BI reader, and using the BI reader to release the germination composition from the germination container, and then bringing the germination composition into contact with the germination pad, the spore carrier, and the plurality of spores.

[0244] Exemplary Embodiment 90: The method according to any one of the exemplary embodiments 78 to 85, further comprising placing the biological indicator in the BI bay of a BI reader, and using the BI reader to break the seal on the outer surface of the biological indicator and release the germination composition from the germination container.

[0245] Exemplary Embodiment 91: The method according to Exemplary Embodiments 78-85, wherein the biological indicator comprises a germination pad, the germination pad, the spore carrier, the germination container, and the window are aligned, and the method further comprises placing the biological indicator on a BI reader and using the BI reader to release the germination composition from the germination container by applying pressure toward the germination container, the germination pad, the spore carrier, and the window.

[0246] Exemplary Embodiment 92: A system for determining the effectiveness of a sterilization process, the system comprising: a biological indicator reader configured to determine the presence of viable spores in at least one biological indicator, the biological indicator reader comprising: a heater block assembly configured to receive the biological indicator and defining at least a portion of at least one BI bay having a BI window; a germination agent initiator disposed above the BI bay; an optical assembly comprising: an excitation source configured to emit light into the biological indicator through the BI window of the BI bay when the biological indicator is present in the BI bay; and a camera assembly having a camera configured to capture an image reflected through the BI window of the BI bay; and a control system having one or more processors, the one or more processors programmed to execute: a heater control module configured to control the heater block assembly; a camera control module configured to control the camera and receive and process an image captured by the camera; and an excitation control module configured to control the excitation source.

[0247] Exemplary Embodiment 93: The system according to Exemplary Embodiment 92, wherein the at least one BI bay comprises a plurality of BI bays, and the optical assembly further comprises a scan head assembly located beneath the heater block assembly, the scan head assembly comprising the excitation source, the scan head body, and a first mirror; a mirror mount located between the scan head assembly and the camera, the mirror mount having a second mirror that reflects light from the scan head assembly to the camera; and a positioning assembly comprising a stepper motor, a belt drive, and a linear guide block, the positioning assembly being mounted on the linear guide block and configured to move beneath the plurality of BI bays, and the one or more processors of the control system being further programmed to run a positioning assembly control module configured to control the positioning assembly.

[0248] Exemplary Embodiment 94: The system according to Exemplary Embodiment 93, wherein the positioning assembly control module includes lockout logic to prevent the positioning assembly from advancing the scan head assembly beyond a predetermined threshold limit.

[0249] Exemplary Embodiment 95: The system according to any of the exemplary embodiments 92-94, wherein the biological indicator reader further comprises a reader housing including a front panel assembly having at least one door opening and at least one access door, the access door being configured to move between an open configuration that exposes the door opening and a closed configuration that closes the door opening, the door opening being configured to receive the biological indicator through the door opening, and the one or more processors of the control system being programmed to run BI bay door and handler modules configured to lock and unlock the at least one access door.

[0250] Exemplary Embodiment 96: The biological indicator reader further includes a germinant activator actuator configured to activate the germinant activator, and the BI bay door and handler module are further configured to control the germinant activator actuator, for the system according to Exemplary Embodiment 95.

[0251] Exemplary Embodiment 97: The biological indicator reader further includes one or more sensors selected from a door position sensor, a germinant activator actuator position sensor, and a BI presence sensor, and the BI bay door and handler module are further configured to communicate with the one or more sensors, for the system according to Exemplary Embodiment 96.

[0252] Exemplary Embodiment 98: The biological indicator reader further includes one or more temperature sensors in the heater block assembly, and the heater control module is configured to receive and process signals from the one or more temperature sensors and control the heating element of the heater block assembly according to the signals from the one or more temperature sensors, for the system according to any of Exemplary Embodiments 92 - 97.

[0253] Exemplary Embodiment 99: The heater control module is configured to prohibit continuous operation of the heating element according to signals from the one or more temperature sensors indicating a temperature difference exceeding a predetermined threshold, for the system according to Exemplary Embodiment 98.

[0254] Exemplary Embodiment 100: The heater control module is configured to execute a heater current monitor and prohibit continuous operation of the heating element when the heater current monitor records a current exceeding a predetermined threshold, for the system according to Exemplary Embodiment 98.

[0255] Exemplary Embodiment 101: The system according to Exemplary Embodiment 95, wherein the at least one BI bay comprises a plurality of BI bays, the excitation control module is configured to receive signals from the BI bay door and handler module indicating which of the plurality of BI bays are occupied by a BI, and to process the signals from the BI bay door and handler module to identify which of the plurality of BI bays require activation of the excitation source and which do not require activation of the excitation source.

[0256] Exemplary Embodiment 102: The system according to any of the exemplary embodiments 92 to 101, wherein the excitation control module is further configured to regulate the current of the excitation source and maintain the current regulation throughout the cycle of the excitation source.

[0257] Exemplary Embodiment 103: The system according to any one of the exemplary embodiments 92 to 102, wherein the excitation control module is configured to control the timing of activation of the excitation source and the exposure length of the excitation source, as well as the timing of activation of the camera and the exposure length of the camera.

[0258] Exemplary Embodiment 104: The system according to any of the exemplary embodiments 92 to 103, wherein the biological indicator reader further comprises a display, and the one or more processors of the control system are further programmed to run a user interface control module configured to manage user-to-display interaction with the display.

[0259] Exemplary Embodiment 105: The system according to Exemplary Embodiment 104, wherein the user interface control module is configured to receive and process user input and manage the display of information to the user on the display.

[0260] Exemplary Embodiment 106: The system according to any of the exemplary embodiments 92 to 105, wherein after the BI is inserted into the BI bay and before the biological indicator reader performs an operation to determine the effectiveness of the sterilization process, the control system is configured to perform a dust check, the dust check comprising examining high-frequency noise in the field of view of the scan head assembly, the presence of high-frequency noise indicating the presence of foreign matter in the optical path of the biological indicator reader.

[0261] Exemplary Embodiment 107: The system according to any of the exemplary embodiments 92 to 106, wherein, after the BI has been inserted into the BI bay and before the biological indicator reader performs an operation to determine the effectiveness of the sterilization process, the control system is configured to perform a condensation check, the condensation check comprising examining condensation formed on the BI window during heating of the heater block assembly.

[0262] Exemplary Embodiment 108: The system according to any of the exemplary embodiments 93 to 107, wherein, after the BI has been inserted into the BI bay and before the biological indicator reader performs an operation to determine the effectiveness of the sterilization process, the control system is configured to perform a positioning check, the positioning check comprising ensuring that the scan head assembly and the positioning assembly are calibrated and confirming a predetermined distance between the scan head assembly and the heater block assembly.

[0263] Exemplary Embodiment 109: The system according to Exemplary Embodiment 108, wherein the positional check includes emitting light toward a self-calibration target of the heater block assembly and measuring the pattern reflected from the self-calibration target to confirm the predetermined distance between the scan head assembly and the heater block assembly.

[0264] Exemplary Embodiment 110: The system according to any of the exemplary embodiments 92 to 109, wherein, before the detection protocol is executed but after the germination activator has been activated, the control system is configured to detect whether the germination has been successfully released from the biological indicator inserted into the BI bay.

[0265] Exemplary Embodiment 111: The system according to Exemplary Embodiment 110, wherein the detection of whether the germination agent has been released normally includes detecting and calculating the average intensity of light emitted over time, wherein an intensity change above a predetermined threshold intensity ratio over time indicates that the germination agent has been released normally, and an intensity change below the predetermined threshold intensity indicates that the release of the germination agent was inappropriate.

[0266] Exemplary Embodiment 112: The system according to any of the exemplary embodiments 93 to 111, wherein the positioning assembly control module is configured to control the operation of the positioning assembly to move the scan head assembly between the plurality of BI bays, the excitation control module is configured to activate the excitation source when the scan head assembly is located below the BI window in the BI bay, and the camera control module is configured to receive and process the image captured by the camera each time the excitation source is activated.

[0267] Exemplary Embodiment 113: The system according to Exemplary Embodiment 112, wherein the positioning assembly control module is configured to circulate the scan head assembly between the multiple BI bays so that the excitation source is activated multiple times under each BI bay during a single cycle of the system, and the camera control module is configured to receive and process the images captured by the camera each time the excitation source is activated.

[0268] Exemplary Embodiment 114: The system according to Exemplary Embodiment 113, wherein the camera is configured to capture a plurality of images of the entire spore carrier, and the camera control module is configured to process the plurality of images captured by the camera pixel by pixel.

[0269] Exemplary Embodiment 115: A method for determining the effectiveness of a sterilization process using a system described in any of the exemplary embodiments 92 to 114, the method comprising: exposing the biological indicator to the sterilization process, the biological indicator comprising a plurality of spores deposited on a spore carrier and a germination container containing a germination composition; inserting the biological indicator into the BI bay of the heater block assembly to heat the biological indicator in the heater block assembly to the culture temperature of the spores; and activating the germination activator to release the germination composition from the germination container into the biological indicator so that the germination composition interacts with the plurality of spores on the spore carrier. The method comprising: emitting light from the excitation source through the BI window of the BI bay and through the imaging window of the biological indicator; capturing a plurality of images over time by the camera from the light reflected through the imaging window of the biological indicator and the BI window of the BI bay; and using the camera control module to compare the plurality of images over time to identify any changes in the intensity of the light reflected through the imaging window of the biological indicator and the BI window of the BI bay, wherein the changes in the intensity of the light reflected over time through the imaging window of the biological indicator and the BI window of the BI bay indicate a failure of the sterilization process.

[0270] Exemplary Embodiment 116: The method of Exemplary Embodiment 115, wherein the biological indicator comprises a plurality of biological indicators, the at least one BI bay comprises a plurality of BI bays, inserting the biological indicator into the BI bays comprises inserting each of the plurality of biological indicators into each of the BI bays, and the method further comprises moving the excitation source between each of the BI bays of the plurality of BI bays.

[0271] Exemplary Embodiment 117: The method of Exemplary Embodiment 116, wherein the optical assembly further comprises a scan head assembly movable between the plurality of BI bays, the scan head assembly comprising the excitation source, the scan head body, and the first mirror, and the method further comprises moving the scan head body, the excitation source, and the first mirror to the first BI bay of the plurality of BI bays; emitting light from the excitation source through the BI window of the first BI bay and through the imaging window of the biological indicator in the first BI bay; and reflecting the light radiated back through the imaging window of the biological indicator and the BI window of the BI bay by the first mirror along a path toward the camera.

[0272] Exemplary Embodiment 118: The method according to any one of the exemplary embodiments 115 to 117, wherein the comparison of the plurality of images with respect to time includes comparing the images pixel by pixel.

[0273] While specific exemplary embodiments of this disclosure have been illustrated and described, it will be recognized by those skilled in the art that various changes and modifications can be made to the described embodiments and their equivalents as defined in the claims that follow this description without departing from the spirit and scope of the invention. For example, certain components may be described in the singular form, i.e., a germinant compound, but one or more of these components may be used in any combination in accordance with this disclosure. Furthermore, certain components may be described as being above or below another component, where “above” and “below” are used as relative terms to aid understanding with reference to the drawings herein. However, it will be understood that the structures, devices, and systems within the scope of this disclosure and claims may, in some cases, be rotated in different orientations such that, for example, “up and down” may be reversed at least temporarily or left and right.

[0274] Furthermore, while certain embodiments are described as "comprising" or "including" certain components, embodiments that "essentially consist of" or "consist of" the enumerated components are also within the scope of this disclosure. For example, an embodiment of this disclosure is described as comprising a BI housing, a germination container, a germination releaser, a germination releaser support, a first spore carrier, and an imaging window, but embodiments that "essentially consist of" or "consist of" these components are also within the scope of this disclosure. Thus, a biological indicator may essentially consist of a BI housing, a germination container, a germination releaser, a germination releaser support, a first spore carrier, and an imaging window. In this context, "essentially consisting of" means that any additional components or process actions do not substantially affect the product or the outcome of the detection cycle (e.g., a system or BI reader).

[0275] Where used herein, unless otherwise expressly designated, all numerical values, such as values, ranges, quantities, or percentages, may be interpreted as being preceded by the word “approximately,” even if the term “approximately” is not explicitly indicated. Furthermore, the word “approximately” is used as an approximation, not as a degree, reflecting a range of variation related to measurement, significant figures, and interchangeability, all of which will be understood by those skilled in the art to which this disclosure belongs. Any numerical ranges listed herein are intended to include all subranges contained within that range. Plural forms include singular forms, and vice versa. For example, this disclosure may describe a germinant compound (“a” germinant compound), but mixtures of such compounds may also be used. Where ranges are given, any endpoint of these ranges and / or any number within these ranges may be combined within the scope of this disclosure. The term “including” and similar terms mean “including, but not limited to,” unless otherwise specified.

[0276] Each value inherently includes a specific error that inevitably arises from the standard deviation observed in each test measurement. The term “comprising” and its inflections as used in this description and in the claims are not intended to limit this disclosure to exclude any variations or additions. (Item 1) It is a biological indicator, Biological indicator (BI) enclosure, Within the aforementioned BI enclosure, there is a germination agent container that contains the germination agent composition before BI is activated, The imaging window on the first surface of the BI enclosure, A first spore carrier within the BI enclosure, wherein the first spore carrier is substantially planar and has a first side and a second side, and the first spore carrier carries a first plurality of spores on its first side, Equipped with, The first side of the first spore carrier and the first plurality of spores present therein are positioned relative to the imaging window and observed through the imaging window. The germination agent composition is configured to come into contact with the first spore carrier and the first plurality of spores present therein after BI activation. The aforementioned biological indicator. (Item 2) The biological indicator according to item 1, further comprising a sprouting pad configured to wick the sprouting composition after BI activation, wherein the sprouting pad is placed on the first spore carrier. (Item 3) The biological indicator further comprises a sprouting pad configured to wick the sprouting composition after BI activation, wherein the sprouting pad is substantially planar and positioned adjacent to the second side of the first spore carrier, as described in any of the preceding items. (Item 4) The system further comprises a germination pad, the germination pad being configured to wick the germination composition after BI activation, the germination pad being substantially planar and positioned adjacent to the second side of the first spore carrier, The first spore carrier is positioned between the germination pad and the imaging window. The first spore carrier, the germination agent pad, and the imaging window are all arranged in a configuration where they are stacked on top of each other in substantially parallel planes. A biological indicator as described in either item 1 or 2. (Item 5) A biological indicator according to any of the preceding items, further comprising a germinator releaser configured to release the germinator composition from the germinator container when the BI is activated, wherein the germinator releaser is movable during the BI activation to release the germinator composition from the germinator container. (Item 6) The biological indicator according to any one of items 2 to 4, further comprising a germination releaser configured to release the germination composition from the germination container, wherein the germination releaser is movable toward the first spore carrier and the germination pad during BI activation to release the germination composition from the germination container, and the germination releaser is configured to press the germination pad against the first spore carrier at least during BI activation to hold the germination pad and the first spore carrier in place. (Item 7) The BI enclosure includes an opening aligned with the germination agent container, the germination agent pad, and the spore carrier, The opening is sealed to prevent the sterilizing agent from entering through the opening before BI activation, and the opening is configured to receive the germination agent release means of the BI reader during BI activation. A biological indicator described in any of the preceding entries. (Item 8) It is a biological indicator, Biological indicator (BI) enclosure, A germination agent container containing a germination agent composition within the aforementioned BI enclosure, A germination agent releaser configured to release the germination agent composition from the germination agent container, A germination agent releaser support for supporting the germination agent releaser, wherein when force is applied to the germination agent releaser support, the germination agent releaser, or the germination agent container, the germination agent releaser support is configured to bring the germination agent releaser into contact with the germination agent container, A first spore carrier that carries a first plurality of spores within the BI enclosure, The imaging window on the first surface of the BI enclosure, The biological indicator comprising the above. (Item 9) The first spore carrier is substantially planar and has a first side and a second side, the first spore carrier carrying the first plurality of spores on its first side, and the first side of the first spore carrier and the first plurality of spores present thereon are positioned relative to the imaging window and observed through the imaging window, the biological indicator according to item 8. (Item 10) The biological indicator according to any one of items 8 and 9, further comprising a sprout pad configured to wick the sprout composition after BI activation, wherein the sprout pad is substantially planar and positioned adjacent to the second side of the first spore carrier, and the sprout pad, the first spore carrier, and the imaging window are in a stacked structure. (Item 11) During BI activation, at least one of the germination agent releaser and the germination agent releaser support is movable toward the first spore carrier and the imaging window, according to any one of items 8 to 10. (Item 12) A biological indicator according to any one of items 8, 9, and 11, further comprising a germination pad between the germination container and the spore carrier, wherein the germination pad comprises a wicking material and is configured to wick the germination from the germination container to the spore carrier. (Item 13) The biological indicator according to any of the preceding items, wherein the BI housing defines an opening along the thickness direction of the biological indicator at a position above or adjacent to the germination releaser, and the opening, the germination container, the germination releaser, the spore carrier, and the imaging window are all stacked along the thickness direction. (Item 14) The biological indicator according to item 13, further comprising a sealant material for sealing the opening before BI activation, wherein the sealant is configured to break down during BI activation. (Item 15) The biological indicator according to either item 13 or 14, wherein the BI housing further comprises a sterile agent entry port at a location different from the opening. (Item 16) The sterilizer entry port is a biological indicator as described in item 15, located on the outer peripheral side wall of the BI housing. (Item 17) The biological indicator according to any one of items 15 and 16, further comprising a second spore carrier in fluid communication with the sterilizer entry port, wherein the second spore carrier carries a second plurality of spores. (Item 18) The germination container is a biological indicator according to any of the preceding items, comprising a glass ampoule, a fragile ampoule, or an outer container having a hollow interior sealed by a barrier. (Item 19) The aforementioned germination agent releaser support is A base that defines the opening of the germination agent releaser that receives the aforementioned germination agent releaser, A plurality of support legs supporting the base, wherein the base is configured to be placed on the germinator container, and at least some of the plurality of support legs have the flexibility to move the base toward the germinator container when downward pressure is applied to the base, A biological indicator comprising any of the items 5-18. (Item 20) The biological indicator according to any of the preceding items, wherein the BI housing comprises a gripping portion and a raised portion, the gripping portion and the raised portion being adjacent to each other along the length dimension of the biological indicator, and the raised portion being configured to house at least a portion of the germination container, the germination releaser, the germination releaser support, and the first spore carrier. (Item 21) The biological indicator according to item 20, wherein the raised portion of the BI housing has an opening of the BI housing positioned above the germination agent releaser along the thickness direction of the raised portion, and the opening, the germination agent container, the germination agent releaser, the spore carrier, and the imaging window are all stacked along the height direction within the raised portion. (Item 22) The raised portion further comprises a sealant material that seals the opening before BI activation, the sealant being destroyed during BI activation, as described in item 21. (Item 23) A biological indicator according to any one of items 20 to 22, further comprising a sterilizer entry port located in the gripping portion of the BI housing. (Item 24) The sterilizer entry port is a biological indicator as described in item 23, located on the outer peripheral side wall of the gripping portion of the BI housing. (Item 25) A biological indicator according to any of the preceding items, further comprising an imaging aperture on the first surface of the BI housing, wherein the imaging window is received in the imaging aperture. (Item 26) The imaging aperture has the shape of Odin's cross, as described in item 25, for the biological indicator. (Item 27) The first spore carrier is a biological indicator described in any of the preceding entries, which is gray or black. (Item 28) The first plurality of spores are supported on the surface of the first spore carrier facing the imaging window, as described in any of items 8 to 27, for the biological indicator. (Item 29) The germination agent releaser support is integrated with the germination agent releaser to form an integrated germination agent releaser having a plurality of rigid support legs and a plurality of releaser protrusions extending toward the barrier of the germination agent container. When force is applied to the germination container and / or the integrated germination releaser, the plurality of releaser protrusions puncture the barrier of the germination container, according to any one of items 8 to 28. (Item 30) The area of ​​the germination pad is greater than the area of ​​the first spore carrier, according to any of items 2-4 and 6-29, as a biological indicator. (Item 31) The size and shape of the first spore carrier are typically biological indicators described in any of the preceding items, corresponding to the size and shape of the imaging window. (Item 32) The biological indicator according to item 17, wherein the second spore carrier, which carries the second plurality of spores, is positioned within the BI enclosure such that the second spore carrier and the second plurality of spores are not exposed to the germination agent when the germination agent is released. (Item 33) A biological indicator according to any of the preceding items, further comprising an insertion groove on a portion of the outer circumferential surface of the BI housing for engaging with a BI reader. (Item 34) The biological indicator according to item 33, wherein the insertion groove comprises a first insertion projection and a second insertion projection at or near the first and second ends of the insertion groove, the first and second insertion projections defining a first insertion notch and a second insertion notch at the first and second ends of the insertion groove. (Item 35) A process challenge device used to determine the effectiveness of a sterilization cycle, wherein the process challenge device is A tray defining the first cavity and tab, A sealing portion configured to be attached to the tray for sealing the first cavity, Sterilizer, sterilization integrator or chemical indicator, Sterilization access port and Equipped with, The first cavity is configured to receive the biological indicator described in any of the preceding items and the sterilizing agent sterilization integrator or the chemical indicator, and the tab is configured to separate the biological indicator from the sterilizing agent sterilization integrator or the chemical indicator. The aforementioned process challenge device. (Item 36) A device for confirming the effectiveness of a sterilization cycle, wherein the device is A process challenge device comprising a sterilizer access port and one or more cavities that are in fluid communication with the sterilizer access port, The process challenge device further comprises a biological indicator as described in any of items 1 to 34 and a chemical indicator or sterilizer sterilization integrator disposed within one or more cavities. The aforementioned device. (Item 37) The process challenge device comprises a tray and a closure portion, wherein one or more cavities are formed in the tray, the closure portion is attached to the tray to maintain a seal during the sterilization process and to hold the biological indicator and the chemical indicator or the sterilizing agent sterilization integrator within the tray, and the closure portion is configured to be broken or removed so that the biological indicator can be removed after the sterilization process, according to item 36. (Item 38) A biological indicator (BI) reader configured to determine the presence of viable spores in at least one biological indicator, wherein the biological indicator reader is A reader housing comprising a front panel assembly having at least one door opening and at least one access door, wherein the access door is configured to move between an open configuration that exposes the door opening and a closed configuration that closes the door opening, and the door opening is configured to receive the biological indicator through the door opening, A heater block assembly that at least partially defines at least one BI bay configured to accept the aforementioned biological indicator and having a BI window, A germination agent starter is placed on the BI bay, An optical assembly, An excitation source configured to emit light through the BI window of the BI bay, A camera assembly having a camera configured to capture images passing through the BI window, The optical assembly includes, A controller configured to control the heater block assembly and the optical assembly, and to collect information related to the image collected by the camera, The biological indicator reader comprising the above. (Item 39) The device further comprises an actuator configured to operate the aforementioned germination agent activator, The BI bay comprises an upper BI bay portion and a lower BI bay portion located below the upper BI bay portion. The germination activator is configured to move through the upper BI bay toward the lower BI bay when activated, as described in item 38, for the biological indicator reader. (Item 40) The actuator is a biological indicator reader as described in item 39, which is operated by a solenoid valve. (Item 41) The optical assembly further, A scan head assembly located below the heater block assembly, The excitation source and, The scan head unit and The first mirror and, The scan head assembly includes, A mirror mount positioned along the optical path between the scan head assembly and the camera, wherein the mirror mount has a second mirror that reflects light from the scan head assembly to the camera, A biological indicator reader, as described in any of items 38-40, comprising the features described therein. (Item 42) The scan head assembly further, The emission lens above the excitation source, The condensing lens on the first mirror and A biological indicator reader as described in item 41, comprising: (Item 43) The excitation source is a biological indicator reader according to any one of items 38 to 42, comprising an ultraviolet light-emitting diode. (Item 44) The at least one BI bay comprises a plurality of BI bays, and the biological indicator reader further comprises a position adjustment assembly, the position adjustment assembly is Stepper motor and Belt drive and Linear guide block and Includes, The scan head assembly is mounted on the linear guide block and configured to move under the plurality of BI bays. A biological indicator reader as described in either item 41 or 42. (Item 45) The biological indicator reader according to any one of items 38 to 44, wherein the at least one BI bay comprises a plurality of BI bays, each BI bay having its own BI window, and the biological indicator reader further comprises a positioning assembly, the positioning assembly comprising the excitation source, configured to move along the plurality of BI bays, and the excitation source can be positioned to sequentially emit light through the respective BI windows of the plurality of BI bays. (Item 46) Rear panel and Axial flow fan, Intake plenum and A biological indicator reader as described in any of items 38-46, further comprising a rear panel assembly including the following. (Item 47) A biological indicator reader according to any one of items 38 to 46, wherein the front panel assembly further includes a latch, and the access door includes a latch plate, and when the access door is in the closed position, the latch of the front panel assembly and the latch plate of the access door are configured to engage and lock the access door. (Item 48) A biological indicator reader according to any one of items 38 to 46, further comprising an access door lock configured to lock the access door when the access door is in the closed position. (Item 49) With additional access door release features, When the access door release is activated, the latch plate of the access door is released from the latch of the front panel assembly, and the access door opens, as described in item 47 of the biological indicator reader. (Item 50) The biological indicator reader described in item 48 further comprises an access door release, wherein when the access door release is activated, the access door lock is released and the access door opens. (Item 51) The access door release communicates with a latch spring of the front panel assembly, and the operation of the access door release compresses the latch spring, resulting in the latch moving, the latch plate being released, and the access door opening, as described in item 49 of the biological indicator reader. (Item 52) The access door release is connected via a leaf spring to a latch spring of the front panel assembly, and the operation of the access door release compresses the latch spring, causing the latch to move, releasing the latch plate, and opening the access door, as described in item 49 of the Biological Indicator Reader. (Item 53) A biological indicator reader according to any one of items 38 to 52, further comprising a door position sensor configured to provide the controller with a signal indicating whether the access door is in the open configuration or the closed configuration. (Item 54) A biological indicator reader according to any one of items 38 to 52, wherein the controller is configured to prevent the opening of the access doors when all of the access doors are in the closed configuration and the biological indicator reader is activated. (Item 55) A biological indicator reader according to any one of items 38 to 54, wherein the controller is configured to prohibit the operation of the biological indicator reader when all of the at least one access doors are in the open configuration. (Item 56) The system further comprises one or more temperature sensors configured to sense the temperature of the heater block assembly, A biological indicator reader according to any one of items 38 to 55, wherein one or more temperature sensors output temperature measurements to the controller, and the controller adjusts the heat output from one or more heating elements of the heater block assembly according to the temperature measurements. (Item 57) Equipped with an additional display, The biological indicator reader according to item 56, wherein one or more temperature sensors output temperature measurements to the controller, and the controller displays information regarding the temperature measurements on the display according to the temperature measurements. (Item 58) A biological indicator reader according to any one of items 38 to 57, wherein when the biological indicator is inserted into the BI bay, the BI window of the BI bay is configured to align with the imaging window of the biological indicator. (Item 59) The BI window is a biological indicator reader as described in any of items 38-58, containing UV-grade fused silica quartz. (Item 60) A biological indicator reader according to any one of items 38 to 59, further comprising a BI presence sensor configured to communicate the presence of a BI in the BI bay to the controller. (Item 61) A biological indicator reader according to any one of items 38 to 60, wherein the BI bay includes a BI latch configured to engage with a portion of the insertion groove of the biological indicator when the biological indicator is inserted into the BI bay, thereby holding the biological indicator in place. (Item 62) A biological indicator reader according to any one of items 38 to 61, wherein when the BI is inserted into the BI bay, the germination release lever is configured to apply downward pressure to the biological indicator and activate the BI. (Item 63) The germination activator is configured to enter the biological indicator and release the germination solution within the biological indicator, as described in any of items 38 to 62, as a biological indicator reader. (Item 64) A biological indicator reader according to any one of items 38 to 63, further comprising a germination starter actuator configured to activate the germination starter. (Item 65) The biological indicator reader according to item 64, wherein when the germination activator is activated, the germination activator actuator is configured to prevent the access door from moving to an open configuration. (Item 66) A biological indicator reader according to any one of items 38 to 65, further comprising an access door lock configured to prevent the access door from moving to the open configuration when the germination agent activator is activated. (Item 67) A biological indicator reader according to any one of items 38 to 66, further comprising a germinator activator position sensor configured to communicate the position of the germinator activator to the controller. (Item 68) The camera assembly is a biological indicator reader as described in any of items 38 to 67, which is positioned in a fixed location. (Item 69) The biological indicator reader according to item 45, wherein the camera assembly is positioned in a fixed position, and the position adjustment assembly further comprises a mirror, the mirror being movable together with the position adjustment assembly. (Item 70) The camera is a biological indicator reader as described in any of items 38 to 69, including a thermoelectric (TE) cooled charge-coupled device (CCD) camera. (Item 71) The camera is a biological indicator reader as described in any of items 38-70, configured to operate in time-gated mode. (Item 72) A biological indicator (BI) reader configured to determine the presence of viable spores in multiple biological indicators using time-gated imaging, wherein the biological indicator reader is A reader housing having a plurality of openings, the reader housing receiving the biological indicator through the plurality of openings, A plurality of BI bays, each of which is accessible through one of the plurality of openings, and each of the plurality of BI bays further has a BI window configured to allow light to enter and leave the BI bay, A plurality of germination agent activaters, each of which is located in one of the plurality of BI bays and configured to activate one of the biological indicators when the biological indicator is present in each of the BI bays, An optical assembly, A movable excitation source configured to sequentially emit light through the BI window of the BI bay, A camera assembly having a camera configured to capture images passing through the BI window of the BI bay and configured to operate in time-gate mode, The optical assembly includes, A controller configured to control the optical assembly and to collect information related to the image collected by the camera, The biological indicator reader comprising the above. (Item 73) The biological indicator reader according to item 72, wherein the controller is configured to move the excitation source between the plurality of BI bays, to cause the excitation source to emit light through the BI window of the BI bay identified as occupied by a BI, and to prevent the excitation source from emitting light through the BI window of the BI bay identified as empty. (Item 74) The plurality of germination agent activators comprises at least one of a plurality of germination agent release levers and a plurality of push rods, as described in either item 72 or 73, as a biological indicator reader. (Item 75) A biological indicator reader according to any one of items 72 to 74, further comprising a movable positioning assembly, the positioning assembly comprising a mirror and the excitation source, the positioning assembly being configured to move along the plurality of BI bays, the excitation source being positioned to sequentially emit light through the respective BI windows of the plurality of BI bays, and the mirror being positioned to sequentially receive light from the respective BI windows of the BI bays. (Item 76) A biological indicator reader according to any one of items 72 to 75, wherein when the biological indicator is inserted into each of the BI bays, each of the germination starters is configured to activate the biological indicator by applying pressure to each of the plurality of biological indicators, causing the germination container in each of the biological indicators to burst. (Item 77) Each of the germination agent activators is configured to enter its own biological indicator reader among the plurality of biological indicators and release the germination agent solution from within the respective biological indicator, as described in any of items 72 to 76. (Item 78) A method for determining the effectiveness of a sterilization process, wherein the method is To provide a biological indicator, wherein the biological indicator has undergone a prior sterilization process, and comprises a plurality of spores deposited on a spore carrier and a germination container containing a germination agent composition, Heating the biological indicator to the culture temperature of the spores, The germination agent composition is released from the germination agent container into the biological indicator so that it interacts with the plurality of spores of the spore carrier. Emitting light from the excitation source through the window of the aforementioned biological indicator, The process involves capturing multiple images over time using a camera from the light reflected through the window of the biological indicator, The process involves comparing the plurality of images over time to determine whether or not a change has occurred in the intensity of the light reflected through the window of the biological indicator, wherein a change in the intensity of the light reflected through the window of the biological indicator over time indicates a failure of the sterilization process. The method, including the method described above. (Item 79) The biological indicator includes a plurality of biological indicators, and the method further includes This includes moving the excitation source between each of the multiple biological indicators, preferably at regular time intervals. The method described in item form 78. (Item 80) The method of item 78 or 79, wherein comparing the aforementioned multiple images with respect to time includes comparing the aforementioned images pixel by pixel. (Item 81) The method according to any one of items 78 to 80, further comprising exposing the biological indicator to the sterilization process before releasing the germination composition from the germination container. (Item 82) The spore carrier is substantially planar, and carries the plurality of spores on its first side, and the first side of the spore carrier is preferably positioned relative to the window of the biological indicator. The method according to any one of items 78 to 81, wherein emitting light from the excitation source through the window of the biological indicator includes emitting light toward the first side of the spore carrier. (Item 83) The method according to any one of items 78 to 82, wherein the spore carrier is substantially planar and carries the plurality of spores on a first side thereof, the first side of the spore carrier is preferably positioned relative to the window of the biological indicator, and capturing the plurality of images over time includes capturing the plurality of images from light emitted by the first side of the spore carrier. (Item 84) The biological indicator includes a plurality of biological indicators, and the method further includes Placing each of the aforementioned multiple biological indicators in each BI bay of the BI reader, Moving the excitation source between the biological indicators in the BI bay, Identify that the excitation source is located in the BI bay, and in accordance with the identification, (i) emit light from the excitation source, and (ii) receive and process the plurality of images from the biological indicator located in the BI bay. The method described in any of items 78-83, including the method described in any of the items 78-83. (Item 85) The biological indicator is placed in one of the multiple BI bays of the BI reader, and the method further, This includes moving the excitation source between the multiple BI bays and activating the excitation source multiple times under each BI bay during one cycle of the system, Each time the excitation source is activated, the camera captures an image. The method described in any of items 78-84. (Item 86) The method according to any one of items 78-85, wherein capturing the aforementioned multiple images includes capturing substantially multiple images of the entire spore carrier. (Item 87) The spore carrier is substantially planar, and the plurality of spores are carried on its first side. The method according to any one of items 78 to 86, wherein the comparison of the plurality of images includes comparing the plurality of images on the first side of the spore carrier pixel by pixel. (Item 88) The method according to any one of items 78 to 86, further comprising placing the biological indicator in the BI bay of a BI reader, and releasing the germination composition from the germination container preferably involves a portion of the BI reader entering the biological indicator, thereby applying pressure from the BI reader, rupturing the germination container, and releasing the germination composition. (Item 89) The biological indicator comprises a germination pad, the spore carrier is substantially planar, and the germination pad, the spore carrier, and the window are stacked in a configuration. The method according to any one of items 78 to 85, further comprising: placing the biological indicator on a BI reader; and using the BI reader to release the germination composition from the germination container, and then bringing the germination composition into contact with the germination pad, the spore carrier, and the plurality of spores. (Item 90) The method according to any one of items 78 to 85, further comprising: placing the biological indicator in the BI bay of a BI reader; and using the BI reader to break the seal on the outer surface of the biological indicator and release the germination composition from the germination container. (Item 91) The method according to items 78-85, wherein the biological indicator comprises a germination pad, the germination pad, the spore carrier, the germination container, and the window are aligned, and the method further comprises placing the biological indicator on a BI reader and using the BI reader to release the germination composition from the germination container by applying pressure toward the germination container, the germination pad, the spore carrier, and the window. (Item 92) A system for determining the effectiveness of a sterilization process, the system comprising a biological indicator reader configured to determine the presence of viable spores in at least one biological indicator, the biological indicator reader is A heater block assembly configured to accept the aforementioned biological indicator and defining at least a portion of at least one BI bay having a BI window, A germination agent starter is placed on the BI bay, An optical assembly, When the biological indicator is present in the BI bay, an excitation source is configured to emit light into the biological indicator through the BI window of the BI bay, A camera assembly having a camera configured to capture images reflected through the BI window of the BI bay, The optical assembly includes, A control system having one or more processors, wherein the one or more processors are programmed to execute a heater control module configured to control the heater block assembly, a camera control module configured to control the camera and receive and process images captured by the camera, and an excitation control module configured to control the excitation source, The system comprising the above. (Item 93) The at least one BI bay includes a plurality of BI bays, and the optical assembly further includes A scan head assembly located below the heater block assembly, The excitation source and, The scan head unit and The first mirror and, The scan head assembly includes, A mirror mount located between the scan head assembly and the camera, wherein the mirror mount has a second mirror that reflects light from the scan head assembly to the camera, A position adjustment assembly, Stepper motor and Belt drive and Linear guide block and The position adjustment assembly includes, The scan head assembly is mounted on the linear guide block and configured to move under the plurality of BI bays. The one or more processors of the control system are further programmed to execute a positioning assembly control module configured to control the positioning assembly. The system described in item 92. (Item 94) The system according to item 93, wherein the position adjustment assembly control module includes lockout logic to prevent the position adjustment assembly from advancing the scan head assembly beyond a predetermined threshold limit. (Item 95) The biological indicator reader further comprises a reader housing including a front panel assembly having at least one door opening and at least one access door, The access door is configured to move between an open configuration that exposes the door opening and a closed configuration that closes the door opening, and the door opening is configured to receive the biological indicator through the door opening. The system according to any one of items 92 to 94, wherein one or more processors of the control system are further programmed to run BI bay door and handler modules configured to lock and unlock the at least one access door. (Item 96) The system according to item 95, wherein the biological indicator reader further comprises a germinator starter actuator configured to activate the germinator starter, and the BI bay door and handler module further comprises a germinator starter actuator configured to control the germinator starter actuator. (Item 97) The system according to item 96, wherein the biological indicator reader further comprises one or more sensors selected from a door position sensor, a germination starter actuator position sensor, and a BI presence sensor, and the BI bay door and handler module are further configured to communicate with the one or more sensors. (Item 98) The system according to any one of items 92 to 97, wherein the biological indicator reader further comprises one or more temperature sensors in the heater block assembly, and the heater control module is configured to receive and process signals from the one or more temperature sensors and to control the heating elements of the heater block assembly in response to the signals from the one or more temperature sensors. (Item 99) The system according to item 98, wherein the heater control module is configured to prohibit the continuous operation of the heating element in response to signals from one or more temperature sensors indicating a temperature difference exceeding a predetermined threshold. (Item 100) The system according to item 98, wherein the heater control module is configured to perform a heater current monitor and, if the heater current monitor records a current exceeding a predetermined threshold, to prohibit the continued operation of the heating element. (Item 101) The system according to item 95, wherein the at least one BI bay comprises a plurality of BI bays, and the excitation control module is configured to receive signals from the BI bay door and handler module indicating which of the plurality of BI bays are occupied by a BI, and to process the signals from the BI bay door and handler module to identify which of the plurality of BI bays require the activation of the excitation source and which of the plurality of BI bays do not require the activation of the excitation source. (Item 102) The excitation control module is further configured to regulate the current of the excitation source and maintain the current regulation throughout the cycle of the excitation source, according to any one of items 92 to 101. (Item 103) The system according to any one of items 92 to 102, wherein the excitation control module is configured to control the timing of activation of the excitation source and the exposure length of the excitation source, as well as the timing of activation of the camera and the exposure length of the camera. (Item 104) The system according to any one of items 92 to 103, wherein the biological indicator reader further comprises a display, and the one or more processors of the control system are further programmed to run a user interface control module configured to manage the interaction between the user and the display. (Item 105) The system according to item 104, wherein the user interface control module is configured to receive and process user input and manage the display of information to the user on the display. (Item 106) After the BI is inserted into the BI bay and before the biological indicator reader performs an operation to determine the effectiveness of the sterilization process, the control system is configured to perform a dust check, which includes examining high-frequency noise within the field of view of the scan head assembly. The system according to any one of items 92 to 105, wherein the presence of high-frequency noise indicates the presence of a foreign object in the optical path of the biological indicator reader. (Item 107) The system according to any one of items 92 to 106, wherein after the BI is inserted into the BI bay and before the biological indicator reader performs an action to determine the effectiveness of the sterilization process, the control system is configured to perform a condensation check, the condensation check includes examining the condensation formed on the BI window during heating of the heater block assembly. (Item 108) The system according to any one of items 93 to 107, wherein after the BI is inserted into the BI bay and before the biological indicator reader performs an action to determine the effectiveness of the sterilization process, the control system is configured to perform a positioning check, the positioning check includes ensuring that the scan head assembly and the positioning assembly are calibrated and confirming a predetermined distance between the scan head assembly and the heater block assembly. (Item 109) The system according to item 108, wherein the position adjustment check includes emitting light toward a self-calibration target of the heater block assembly and measuring the pattern reflected from the self-calibration target to confirm the predetermined distance between the scan head assembly and the heater block assembly. (Item 110) The system according to any one of items 92 to 109, wherein, before executing the detection protocol but after the germination starter has been activated, the control system is configured to detect whether the germination has been successfully released from the biological indicator inserted into the BI bay. (Item 111) The detection of whether the germination agent has been released normally includes detecting and calculating the average intensity of light emitted over time. The system described in item 110, wherein a change in intensity above a predetermined threshold intensity ratio over time indicates that the germination agent was released normally, and a change in intensity below the predetermined threshold intensity indicates that the release of the germination agent was inappropriate. (Item 112) The system according to any one of items 93 to 111, wherein the positioning assembly control module is configured to control the operation of the positioning assembly to move the scan head assembly between the plurality of BI bays, the excitation control module is configured to activate the excitation source when the scan head assembly is located below the BI window in the BI bay, and the camera control module is configured to receive and process the image captured by the camera each time the excitation source is activated. (Item 113) The system according to item 112, wherein the positioning assembly control module is configured to circulate the scan head assembly between the multiple BI bays so that the excitation source is activated multiple times under each BI bay during one cycle of the system, and the camera control module is configured to receive and process the images captured by the camera each time the excitation source is activated. (Item 114) The system according to item 113, wherein the camera is configured to capture a plurality of images of the entire spore carrier, and the camera control module is configured to process the plurality of images captured by the camera pixel by pixel. (Item 115) A method for determining the effectiveness of a sterilization process using a system described in any of items 92 to 114, wherein the method is: Exposing the biological indicator to the sterilization process, wherein the biological indicator comprises a plurality of spores deposited on a spore carrier and a germination container containing a germination agent composition, Insert the biological indicator into the BI bay of the heater block assembly and heat the biological indicator within the heater block assembly to the spore culture temperature, The germination agent is activated to release the germination agent composition from the germination agent container into the biological indicator so that the germination agent composition interacts with the plurality of spores of the spore carrier. The excitation source emits light through the BI window of the BI bay and through the imaging window of the biological indicator. Multiple images are captured over time by the camera from the light reflected through the imaging window of the biological indicator and the BI window of the BI bay. Using the camera control module, compare the plurality of images over time to identify any changes in the intensity of the light reflected through the imaging window of the biological indicator and the BI window of the BI bay, wherein changes in the intensity of the light reflected through the imaging window of the biological indicator and the BI window of the BI bay over time indicate a failure of the sterilization process, and to identify such changes. The method, including the method described above. (Item 116) The biological indicator includes a plurality of biological indicators, and the at least one BI bay includes a plurality of BI bays. The method according to item 115, wherein inserting the biological indicators into the BI bays includes inserting each of the plurality of biological indicators into each of the BI bays, and the method further includes moving the excitation source between each of the BI bays among the plurality of BI bays. (Item 117) The optical assembly further, The scan head assembly is movable between the plurality of BI bays, and the scan head assembly is The excitation source and, The scan head unit and The first mirror and, Equipped with, The above method further, The scan head body, the excitation source, and the first mirror are moved to the first BI bay of the plurality of BI bays. The excitation source emits light through the BI window of the first BI bay and through the imaging window of the biological indicator in the first BI bay, The light radiated through the imaging window of the biological indicator and the BI window of the BI bay is reflected along the path toward the camera using the first mirror. The method described in item 116, including the method described in item 116. (Item 118) The method described in any of items 115 to 117, wherein comparing the aforementioned multiple images with respect to time includes comparing the aforementioned images pixel by pixel.

Claims

1. It is a biological indicator, Biological indicator (BI) enclosure, The germination agent container within the BI enclosure, wherein the germination agent container contains the germination agent composition before the BI is activated, The imaging window on the first surface of the BI enclosure, The first spore carrier in the BI enclosure is substantially planar and has a first side and a second side, and the first spore carrier carries a first plurality of spores on its first side. The first side of the first spore carrier and the first plurality of spores present therein are arranged substantially parallel to the imaging window and observed through the imaging window, the first spore carrier and A germination agent releaser configured to release the germination agent composition from the germination agent container, A germination agent releaser support for supporting the germination agent releaser, wherein the germination agent releaser support is configured such that when force is applied to the germination agent releaser support or the germination agent container, the germination agent releaser support brings the germination agent releaser into contact with the germination agent container, Equipped with, The germination agent composition is configured to come into contact with the first spore carrier and the first plurality of spores present therein after BI activation. The BI housing defines an opening above or adjacent to the germination releaser, and the opening is configured to receive the germination release means of the BI reader during BI activation to release the germination composition from the germination container. The BI enclosure further includes a sterilizer entry port at a position different from the opening, Before BI activation, the opening is sealed with a sealant material to exclude the sterilizer, and the sterilizer entry port is open to accept the sterilizer, in a biological indicator.

2. The biological indicator according to claim 1, wherein the BI housing comprises a gripping portion and a raised portion, the gripping portion and the raised portion being adjacent to each other along the length dimension of the biological indicator, and the raised portion being configured to house at least a portion of the germination agent container and the first spore carrier.

3. The biological indicator according to any one of claims 1 to 2, further comprising a sprouting pad configured to wick the sprouting composition after BI activation, wherein the sprouting pad is substantially planar and positioned adjacent to the second side of the first spore carrier.

4. The system further comprises a germination pad, the germination pad being configured to wick the germination composition after BI activation, the germination pad being substantially planar and positioned adjacent to the second side of the first spore carrier, The first spore carrier is positioned between the germination pad and the imaging window. The first spore carrier, the germination agent pad, and the imaging window are all arranged in a configuration where they are stacked on top of each other in substantially parallel planes. A biological indicator according to either claim 1 or 2.

5. The biological indicator according to any one of claims 3 to 4, wherein the germination agent releaser is movable toward the first spore carrier and the germination agent pad during BI activation to release the germination agent composition from the germination agent container, and the germination agent releaser is configured to press the germination agent pad against the first spore carrier at least during BI activation to hold the germination agent pad and the first spore carrier in a predetermined position.

6. The opening is aligned with the germination agent container, the germination agent pad, and the first spore carrier. A biological indicator according to any one of claims 3 to 5.

7. It is a biological indicator, Biological indicator (BI) enclosure, The germination agent container within the BI enclosure comprises a germination agent container that contains a germination agent composition, A germination agent releaser configured to release the germination agent composition from the germination agent container, A germination agent releaser support for supporting the germination agent releaser, wherein the germination agent releaser support is configured such that when force is applied to the germination agent releaser support, the germination agent releaser, or the germination agent container, the germination agent releaser contacts the germination agent container, The first spore carrier in the BI enclosure comprises a first spore carrier that carries a first plurality of spores, The imaging window on the first surface of the BI enclosure, Equipped with, The BI housing defines an opening above or adjacent to the germination releaser, and the opening is configured to receive the germination release means of the BI reader during BI activation to release the germination composition from the germination container. The BI enclosure further includes a sterilizer entry port at a position different from the opening, Before BI activation, the opening is sealed with a sealant material to exclude the sterilizer, and the sterilizer entry port is open to accept the sterilizer, in a biological indicator.

8. The biological indicator according to claim 7, wherein the first spore carrier is substantially planar and has a first side and a second side, the first spore carrier carries a first plurality of spores on its first side, and the first side of the first spore carrier is positioned substantially parallel to the imaging window and is observed through the imaging window.

9. The biological indicator according to any one of claims 7 and 8, further comprising a sprout pad configured to wick the sprout composition after BI activation, wherein the sprout pad is substantially planar and positioned adjacent to the second side of the first spore carrier, and the sprout pad, the first spore carrier, and the imaging window are in a stacked structure.

10. The biological indicator according to any one of claims 7 to 9, wherein, during BI activation, at least one of the germination agent releaser and the germination agent releaser support is movable toward the first spore carrier and the imaging window.

11. A biological indicator according to any one of claims 7, 8, and claim 10 as dependent on claim 7 or 8, further comprising a germination pad between the germination container and the first spore carrier, wherein the germination pad comprises a wicking material and is configured to wick the germination composition from the germination container toward the first spore carrier.

12. The biological indicator according to any one of claims 1 to 11, wherein the opening, the germination container, the germination releaser, the first spore carrier, and the imaging window are all stacked along the thickness direction of the biological indicator.

13. The biological indicator according to claim 12, wherein the sealant of the sealant material is configured to be destroyed during BI activation.

14. The biological indicator according to claim 12, wherein the sterilizer entry port is located on the outer peripheral side wall of the BI housing.

15. The biological indicator according to any one of claims 12 and 14, further comprising a second spore carrier in fluid communication with the sterilizer entry port, wherein the second spore carrier carries a second plurality of spores.

16. The biological indicator according to any one of claims 1 to 15, wherein the germination agent container includes a glass ampoule, a fragile ampoule, or an outer container having a hollow interior sealed by a barrier.

17. The aforementioned germination agent releaser support is A base that defines the opening of the germination agent releaser that receives the aforementioned germination agent releaser, A plurality of support legs supporting the base, wherein the plurality of support legs are configured such that the base is placed on the germinator container, and at least some of the plurality of support legs have the flexibility to move the base toward the germinator container when downward pressure is applied to the base, A biological indicator according to any one of claims 5 to 16, comprising:

18. The biological indicator according to any one of claims 1 to 12, wherein the BI housing comprises a gripping portion and a raised portion, the gripping portion and the raised portion being adjacent to each other along the length dimension of the biological indicator, and the raised portion being configured to house at least a portion of the germination container, the germination releaser, the germination releaser support, and the first spore carrier.

19. The biological indicator according to claim 18, wherein the raised portion of the BI housing has an opening of the BI housing positioned on the germination agent releaser along the thickness direction of the raised portion, and the opening, the germination agent container, the germination agent releaser, the first spore carrier, and the imaging window are all stacked along the height direction within the raised portion.

20. The biological indicator according to claim 19, wherein the raised portion comprises the sealant material, the sealant material seals the opening before BI activation, and the sealant of the sealant material is destroyed during BI activation.

21. The biological indicator according to any one of claims 18 to 20, wherein the sterilizer entry port is located in the gripping portion of the BI housing.

22. The biological indicator according to claim 21, wherein the sterilizer entry port is located on the outer peripheral side wall of the gripping portion of the BI housing.

23. The biological indicator according to any one of claims 1 to 22, wherein the first surface of the BI housing further comprises an imaging aperture, and the imaging window is received in the imaging aperture.

24. The biological indicator according to claim 23, wherein the imaging aperture has the shape of Odin's cross.

25. The first spore carrier is gray or black, according to any one of claims 1 to 24, as a biological indicator.

26. The first plurality of spores are supported on the surface of the first spore carrier facing the imaging window, according to any one of claims 7 to 25, as a biological indicator.

27. The germination agent releaser support is integrated with the germination agent releaser to form an integrated germination agent releaser having a plurality of rigid support legs and a plurality of releaser protrusions extending toward the barrier of the germination agent container. The biological indicator according to any one of claims 7 to 26, wherein when force is applied to the germination container and / or the integrated germination releaser, the plurality of releaser protrusions puncture the barrier of the germination container.

28. The biological indicator according to any one of claims 3 to 6, 9, or 11, wherein the area of ​​the germination pad is larger than the area of ​​the first spore carrier.

29. The size and shape of the first spore carrier typically correspond to the size and shape of the imaging window, according to any one of claims 1 to 28.

30. The biological indicator according to claim 15, wherein the second spore carrier, which carries the second plurality of spores, is positioned within the BI enclosure such that the second spore carrier and the second plurality of spores are not exposed to the germination composition when the germination composition is released.

31. The biological indicator according to any one of claims 1 to 30, further comprising an insertion groove on a portion of the outer circumferential surface of the BI housing for engaging with a BI reader.

32. The biological indicator according to claim 31, wherein the insertion groove comprises a first insertion projection and a second insertion projection at or near the first and second ends of the insertion groove, and the first and second insertion projections define a first insertion notch and a second insertion notch at the first and second ends of the insertion groove.

33. The biological indicator according to any one of claims 1 to 6, wherein the BI housing comprises a gripping portion and a raised portion, the gripping portion and the raised portion being adjacent to each other along the length dimension of the biological indicator, and the raised portion being configured to house at least a portion of the germination container, germination releaser, germination releaser support, and the first spore carrier.

34. The biological indicator according to claim 2 or 33, wherein the sterilizer entry port is located on the gripping portion of the BI housing.

35. The biological indicator according to any one of claims 2 or 33 to 34, wherein the opening, the germination container, the first spore carrier, and the imaging window are all stacked in the height direction within the raised portion.

36. The biological indicator according to claim 2 or any one of claims 33 to 35, wherein the opening, the germination container, the germination releaser, the first spore carrier, and the imaging window are all stacked in the height direction within the raised portion.

37. The biological indicator according to any one of claims 35 to 36, wherein the raised portion comprises the sealant material, the sealant material seals the opening before BI activation, and the sealant of the sealant material is destructible during BI activation.

38. The opening is sealed with the sealant material to prevent the sterilizing agent from entering during sterilization and before BI activation, and the sealant material is destroyable by a biological indicator reader when BI is activated. A separate sterilizer opening provides a pathway for the sterilizer to enter the BI housing during sterilization, according to any one of claims 1 and 7.

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