Determining the effectiveness of a sterilization procedure from outside a sterilization package

Abstract

An example sterilization indicator (102) includes a cover (122), an indicator (102), and a seal (142). The cover (122) defines at least a portion of a cavity (138). The indicator (102) is disposed within the cavity (138). The indicator (102) is configured to fluidly couple with an interior cavity (110) of a sterilization package (package) and indicate exposure to a sterilant. The seal (142) is configured to form a microbial barrier between an exterior of the cover (122) and the interior cavity (110) of the sterilization package (100).

Description

Technical Field

[0001] This application relates to articles, systems, and techniques for determining the effectiveness of a sterilization procedure from outside the sterilization package. Background Technology

[0002] Medical devices are cleaned, assembled, processed, packaged, stored, and dispensed by the hospital's central sterilization or aseptic processing department for use in patient care. Typically, once opened in the operating room or other point of use, a sterilization indicator placed in the sterilization package before sterilization is used to determine whether the devices in the sterilization package have been thoroughly sterilized. Summary of the Invention

[0003] This disclosure relates to articles, systems, and techniques for determining the effectiveness of a sterilization procedure using indicators disposed on the exterior of a sterilization package. The described articles, systems, and techniques include externally visible, internally sampling sterilization indicators configured to enable the assessment of the presence and status of chemical indicators prior to delivery of a medical device to the operating room.

[0004] In some examples, this disclosure relates to a sterilization indicator including a cover, an indicator, and a seal. The cover defines at least a portion of a cavity. The indicator is disposed within the cavity. The indicator is configured to be in fluid communication with the inner cavity of the sterilized package and to indicate exposure to a sterilizing agent. The seal is configured to form a microbial barrier between the exterior of the cover and the inner cavity of the sterilized package.

[0005] In one example, this disclosure relates to a sterilization package including a housing and a sterilization indicator disposed on an outer surface of the housing. The housing includes an outer surface and defines an internal cavity. At least a portion of the housing includes a sterilizing agent permeable area. The sterilization indicator includes a cover, an indicator, and a seal. The cover defines at least a portion of the cavity. The indicator is disposed within the cavity and is in fluid communication with the internal cavity of the housing. The indicator is configured to indicate exposure to a sterilizing agent within the internal cavity. The seal is configured to form a microbial barrier between the exterior of the housing and the internal cavity of the housing.

[0006] In some examples, this disclosure relates to a method of forming a sterilization indicator. The method includes forming a cover that defines at least a portion of a cavity. The method further includes positioning the indicator within the cavity. The indicator is configured to be fluidly connected to an internal cavity of the sterilization package and to indicate exposure to a sterilizing agent. The method also includes disposing a seal adjacent to the cover. The seal is configured to form a microbial barrier between the exterior of the cover and the cavity of the sterilization package.

[0007] In some examples, this disclosure relates to a method of using a sterilization indicator. The method includes positioning the sterilization indicator on an outer surface of a housing, the housing defining an internal cavity. At least a portion of the outer surface includes a sterilizing agent permeable area. The method further includes exposing the sterilization indicator and housing to a sterilizing agent for a selected duration, a selected temperature, and / or a selected sterilizing agent concentration. The method also includes determining, via the indicator, whether the internal cavity of the housing is exposed to at least one of a threshold exposure duration, a threshold sterilizing agent temperature, or a threshold sterilizing agent concentration.

[0008] Details of one or more embodiments of the present invention are shown in the following drawings and description. Other features, objects, and advantages of the invention will become apparent from the description and drawings, as well as from the claims. Attached Figure Description

[0009] Figure 1 This is a conceptual cross-sectional view of an exemplary sterilization package, which includes a sterilization indicator positioned on the outer surface of the housing.

[0010] Figure 2 A to Figure 2 C is a conceptual diagram showing several views of an exemplary sterilization indicator.

[0011] Figure 3 A and Figure 3 B is a conceptual diagram showing a perspective view of an exemplary sterilization indicator that includes a process challenge device.

[0012] Figure 4 The diagram illustrates a concept of an exemplary sterilization package, which includes a sterilization indicator positioned on the outer surface of the housing.

[0013] Figure 5 This is a conceptual diagram showing a perspective view of an exemplary sterilizing agent indicator.

[0014] Figure 6 A and Figure 6 B is a conceptual diagram showing a perspective view of an exemplary sterilization indicator.

[0015] Figure 7 This is a conceptual diagram showing a portion of an exemplary sterilization package, which includes a flip-top sterilization indicator.

[0016] Figure 8 A to Figure 8 E is a conceptual diagram illustrating an exemplary component of a sterilization package.

[0017] Figure 9 is a conceptual diagram showing a perspective view of a flexible sterilization package, which includes multiple sterilization indicators adhered to the package.

[0018] Figure 10 is a flowchart illustrating an exemplary technique for forming a sterilization indicator.

[0019] Figure 11 is a flowchart illustrating an exemplary technique using a sterilization indicator.

[0020] In these accompanying figures, similar symbols represent similar elements. Detailed Implementation

[0021] This disclosure describes articles, systems, and techniques for assessing the presence and condition of sterilization inside a closed sterilization package from the outside. Such sterilization indicators include externally visible, internally sampled sterilization indicators (hereinafter referred to as sterilization indicators). Exemplary sterilization indicator systems may include, for example, a chemical or biological sterilization indicator, a housing surrounding the sterilization indicator, a conduit fluidly connected to the interior of the housing via a sampling port, one or more seals, and an optional locking mechanism configured to provide a sterile barrier between the interior of the housing and the environment outside the housing and the sterilization package, the optional locking mechanism being configured to secure the sterilization indicator to the sterilization package in a damage-resistant manner.

[0022] Various products and articles, including medical devices, apparatus, bandages, and equipment, must be sterilized before use to prevent biological contamination of wound sites, samples, organisms, etc. Used medical devices received from the operating room undergo sterilization procedures in the decontamination area of ​​the aseptic processing department. Used medical devices are processed through manual and / or automated cleaning and disinfection procedures, and then packaged in flexible or rigid containers (e.g., sterilization packs). The sterilization pack material and sterilization method allow the sterilizing agent to pass through a sterilizing agent-permeable but microbial-impermeable material during sterilization. The sterilization pack material protects the devices from microbial contamination during storage and handling.

[0023] Typically, an internal sterilization indicator (e.g., not externally visible) is placed inside the sterilization package before it is sealed. After sealing, the package is sterilized using a sterilizing agent (such as steam, ethylene oxide, dry heat, or hydrogen peroxide vapor). After sterilization, the instruments are stored, for example, for several minutes to several weeks, until required by the operating room. The internal sterilization indicator provides a visual indication of the effectiveness of the sterilization procedure. Because some sterilization packages are not made of transparent materials, visualization of the internal sterilization indicator requires opening the packaging or container.

[0024] One method for viewing and obtaining information about sterilizer functionality is the use of test packs. Test packs may include model packs constructed to simulate degassing and the penetration of sterilizing agents into a sterilization pack containing instruments. Because test packs typically do not include the instruments to be used in the medical procedure, they can be placed in the same sterilization cycle as the instrument sterilization pack and can be opened and inspected after sterilization without damaging any instruments intended for use in the medical procedure. However, sterilization loads often contain a mixture of different types of sterilization packing materials, such as wrapped instrument kits, rigid containers, and other sterilization pack forms. Each sterilization pack may also contain different amounts of material within the sterilization packing material, thus limiting the use and construction of universal test packs. Furthermore, changing the number or orientation of sterilization packs in a given sterilization load can affect the sterilization effectiveness of certain types of sterilization packs. Using multiple test packages designed to simulate a wider range of packaging material types and load conditions may be limited by the available space within the sterilizer and / or by the procedural complexity for sterilization technicians (e.g., in determining which test packages to use for various combinations of packaging materials and load levels), which could lead to increased operator error.

[0025] One method for viewing and obtaining information from the internal environment of a sterilization package is to place an indicator inside the package, then open the package after the sterilization procedure and check the sterilization indicator. For example, during the setup of an operating room for surgical procedures, a sterilization package containing a designated instrument set is moved into the operating room. Once inside the operating room, the package can be opened and one or more internal sterilization indicators can be checked for their presence. The internal sterilization indicator can be used to assess the effectiveness of the sterilization procedure. For example, it can be used to assess whether the internal cavity of the package has been exposed to a sterilizing agent for at least one of a threshold exposure duration, a threshold sterilizing agent temperature, or a threshold sterilizing agent concentration. As used herein, the threshold exposure duration, threshold sterilizing agent temperature, or threshold sterilizing agent concentration may include thresholds generally accepted for the corresponding sterilization procedure.

[0026] Unless the internal sterilization indicator provides a visual indication that the sterilization procedure is effective, the instrument kit is considered contaminated and must be reprocessed before use. Reprocessing sterilization kits can have adverse consequences, including reduced productivity in the aseptic processing department and delayed surgeries. In emergency situations, hospitals may use ready-to-use sterilization, a process that may be less effective than other sterilization procedures. Therefore, minimizing reprocessing may be advantageous.

[0027] Another method for viewing and obtaining information about the internal environment of a sterilization package from a sterilization indicator is to introduce a transparent or ultra-thin element (such as a window) within the container or package, through which the indicator can be visualized. However, such modifications can significantly increase the manufacturing cost and complexity of the sterilization package.

[0028] The described sterilization indicator (e.g., externally visible, internally sampled) articles, systems, and techniques enable operators (e.g., technicians or clinicians) to determine, without opening the sterilization package, whether the contents inside the sealed sterilization package have been exposed to the sterilizing agent for a threshold time, threshold temperature, and / or threshold concentration. This allows for the assessment of sterilization effectiveness within aseptic processing departments, for example, before the sterilization package is moved into the operating room. The described articles, systems, and techniques can reduce costs and / or delays associated with sterilization package contamination occurring in the operating room. Additionally, or alternatively, the described articles, systems, and techniques can reduce costs and / or improve throughput by eliminating the use of test packages. Additionally, or alternatively, the described articles, systems, and techniques can reduce sterilization package costs associated with introducing a transparent window into the sterilization package. Additionally, or alternatively, by using a sampling port to connect an external sterilization indicator to the internal contents flow of the tray, the described articles, systems, and techniques provide an externally visible sterilization indicator that can reduce or prevent operator errors in failing to place an internal sterilization indicator inside the sterilization package before sterilization.

[0029] Figure 1 This is a conceptual cross-sectional view of an exemplary sterilization package 100, which includes a sterilization indicator 102 positioned on the outer surface 106 of a housing 104. The housing 104 is configured to receive an article of manufacture, such as a medical device, for sterilization. The sterilization indicator 102 is configured to provide an externally visible indication of whether sterilization parameters are met during the sterilization process of the article of manufacture.

[0030] The housing 104 may define one or more of a base, one or more sidewalls, and / or a top or removable cover. The housing 104 includes an outer surface 106 and an inner surface 108. The inner surface 108 defines an internal cavity 110. The internal cavity 110 is sized and shaped to receive one or more articles to be sterilized. In some examples, the internal cavity 110 may be shaped to receive one or more sterilization trays. The sterilization trays may be configured to hold the articles and reduce contact between the articles and the inner surface 108 and / or sterilizing agents (such as condensate), which may remain within the internal cavity 110 after sterilization.

[0031] The housing 104 may include a rigid container, flexible packaging, or a sterilization tray. Typically, the housing 104 may contain any material suitable for sterilizing and storing sterilized articles. In examples where the housing 104 includes a rigid container, the housing 104 may contain a rigid material, such as, for example, aluminum, stainless steel, or other metals or polymers compatible with steam, ethylene oxide, dry heat, and / or vaporized hydrogen peroxide sterilization. In examples where the housing 104 includes flexible packaging, the housing 104 may contain a flexible material, such as, for example, fabric or nonwoven fabric, spunbond-meltblown-spunbond nonwoven material, synthetic fibers, natural fibers, polyethylene, polypropylene, or combinations thereof. In some examples, the flexible material may be selected to have selected permeability in combination with selected sterilizing agents such as steam, ethylene oxide, dry heat, vaporized hydrogen peroxide, or other sterilizing agents. In some examples, the flexible material may include a microbial barrier layer. For example, the flexible material may be substantially impermeable to microorganisms such as bacteria, fungi, viruses, etc. Substantially impermeable may include impermeable or nearly impermeable, according to generally accepted sterilization procedure guidelines. For the purposes of this disclosure, rigid materials may include materials that are harder than flexible materials (e.g., have a greater Young's modulus).

[0032] At least a portion of the outer casing 104 includes a sterilizing agent permeable region 112. The sterilizing agent permeable region 112 may include at least one region comprising the flexible material described above with respect to the flexible packaging outer casing 104. In examples where the outer casing 104 comprises a flexible packaging material, the entirety of the outer casing 104 or at least a portion of the outer casing 104 may define the sterilizing agent permeable region 112. In examples where the outer casing 104 comprises a rigid material, such as... Figure 1 As shown, the sterilizing agent permeable area 112 may include a plurality of pores 114 and a filter 116. For example, a portion of the housing 104 (such as a sidewall, base, or removable cap of the housing 104) may define a plurality of pores 114. The plurality of pores may be drilled into the housing 104 or otherwise mechanically formed. The filter 116 contains a sterilizing agent permeable microbial barrier material. For example, the filter 116 may contain the flexible material described above with respect to the flexible packaging housing 104. In this way, during sterilization, the sterilizing agent may move from the sterilization chamber 118 through the pores 114 and the filter 116 into the inner cavity 110, as indicated by dashed arrow 120. The sterilizing agent may move from the inner cavity 110 into the sterilization indicator 102, as indicated by dashed arrow 121.

[0033] Sterilization indicator 102 may include an article containing a sterilizing agent exposure indicator 128 (indicator 128) configured to provide indication of exposure to sterilizing agent from internal cavity 110 (e.g., via dashed arrow 121). Sterilization indicator 102 may include a layered or laminated structure, a molded structure, or a combination thereof. For example, as Figure 1 As shown, the sterilization indicator 102 may include a cover layer 122 and a base layer 132 adjacent to the indicator 128, and an intermediate layer 130 extending between the cover layer 122 and the base 132. In some examples, the intermediate layer 130 may be integrally formed with either the cover layer 122 or the base 132. In some examples, the sterilization indicator 102 may include the cover layer 122 and the intermediate layer 130, which may optionally be integrally formed with the cover layer 122 instead of the base 132. In some examples, the sterilization indicator 102 may include only the cover layer 122, which is configured to be attached / attached to the outer surface 106 of the housing 104, for example, using an adhesive.

[0034] In some examples, the cover 122 may have a linear shape defining an upper surface 124 and a lower surface 126 opposite to the surface 124, and extending in a plane substantially parallel to the plane of the surface 124. The cover 122 may comprise any material suitable for steam, ethylene oxide, dry heat, or vaporized hydrogen peroxide sterilization procedures. In some examples, the cover 122 may comprise metal, aluminum, anodized aluminum, stainless steel, glass, polymeric materials, polyethylene, polypropylene, polycarbonate, polyethersulfone, polyamide-imide, polyamide, polytetrafluoroethylene, or combinations thereof. At least a portion of the cover 122 comprises a transparent or translucent material configured to visualize the sterilizing agent exposure indicator 128. For example, the entire cover 122 may comprise a transparent material, or a portion of the cover 122 (e.g., a window) may comprise a transparent material.

[0035] In some examples, the base 132 may include a linear shape defining an upper surface 134 and a lower surface 136 opposite to surface 134, and extending in a plane substantially parallel to the plane of surface 134. The base 132 may contain any one or more of the materials described above with respect to the cover 122. In some examples, the base 132 may contain any one or more of the materials described above with respect to the cover 122. In some examples, the base 132 may include an adhesive layer and / or a release liner. The adhesive layer may include, for example, pressure-sensitive adhesives, hot-melt adhesives, structural adhesives, thermoplastics, thermosetting polymers, epoxy resins, or adhesives suitable for steam, ethylene oxide, dry heat, or vaporized hydrogen peroxide sterilization procedures and selectively adhered to the outer surface of a rigid container or flexible packaging. In some examples, the adhesive layer may define a seal configured to form a microbial barrier between the exterior of the housing 104 and the internal cavity 110 of the housing 104. Before the sterilization indicator 102 is positioned on the housing 104, the release liner may be removable, for example, removed from the adhesive layer. For example, the cover 122 may be peripherally coupled to the base 132 defining the release liner, such that the indicator 128 is disposed between the release liner and the cover 122.

[0036] In some examples, the intermediate layer 130 may extend between the cover 122 and the base 132, thereby defining a straight loop in the planes of surfaces 126 and 134. For example, the intermediate layer 130 may define a cavity 138 configured to receive at least a portion of the indicator 128. In some examples, at least a portion of the intermediate layer 130 may extend between at least a portion of the cover 122 and at least a portion of the indicator 128, between at least a portion of the base 132 and at least a portion of the indicator 128, or both.

[0037] As an example, the indicator 128 may be smaller in size than the cover 122 and the base 132. In this way, one or more peripheral edges of both the cover 122 and the base 132 may extend beyond the periphery of the indicator 128. The indicator 128 may be disposed on surface 126 of the cover 122 and / or surface 134 of the base 132. In some examples, the indicator 128 may be disposed directly on surface 126 and / or surface 134. In some examples, one or more additional intermediate layers may be disposed between the indicator 128 and surface 126 and / or surface 134. For example, the one or more additional intermediate layers may include an adhesive, a filter material, or a fluid.

[0038] By extending beyond the periphery of indicator 128, one or more peripheral edges of the cover 122 and base 132 may be adhered to or otherwise secured to the intermediate layer 130 to substantially encapsulate indicator 128. In some examples, the intermediate layer 130 may comprise any one or more of the materials described above with reference to cover 122. In some examples, the intermediate layer 130 may comprise a sterilizing agent impermeable layer, a microbial barrier layer, and / or a color-enhancing layer. The color-enhancing layer may comprise any suitable material configured to improve the visualization of at least a portion of indicator 128 in response to color changes during sterilization exposure to a sterilizing agent. In some examples, the color-enhancing layer may be adjacent to one or more of cover 122 and / or base 132.

[0039] In some examples, the intermediate layer 130 may define an adhesive configured to adhere the cover 122 to the base 132. The adhesive may include, for example, pressure-sensitive adhesives, hot-melt adhesives, structural adhesives, thermoplastics, thermosetting polymers, epoxy resins, or adhesives suitable for steam, ethylene oxide, dry heat, or vaporized hydrogen peroxide sterilization procedures. In some examples, at least one of the cover 122 and / or the base 132 may be secured to at least a portion of the intermediate layer 130 using other fastening methods such as thermal welding, acoustic welding, heat sealing, mechanical fasteners, or other suitable fastening techniques. In some examples, essentially encapsulating the indicator 128 prevents the sterilizing agent in the sterilization chamber 118 from contacting the indicator 128 without first entering the internal cavity 110 of the housing 104.

[0040] Indicator 128 may include at least one of a chemical indicator, a biological indicator, or an indicator configured to provide an indication of exposure to a sterilizing agent. In some examples, indicator 128 may include an Attest VH202 Tri-Metric indicator available from 3M, St. Paul, Minnesota, or a 3M Comply SteriGage vapor chemical integrator available from 3M, St. Paul, Minnesota. Although described herein as a visual indicator, in some examples the indicator may include, for example, a change in an electrical signal, a change in an optical signal, or a change in a physical phenomenon.

[0041] Indicator 128 (e.g., cavity 138) is fluidly connected to the internal cavity 110 of housing 104. For example, base 132 may define one or more pores 140 that allow cavity 138 to be fluidly connected to the internal cavity 110 of housing 104 of sterilization package 100. In an example where housing 104 comprises a flexible package, pores 140 allow sterilizing agent to enter cavity 138 from internal cavity 110 during sterilization. In an example where housing 104 comprises a rigid container, pores 140 allow sterilizing agent to enter cavity 138 from internal cavity 110, through at least a portion of filter 116, and through one or more pores in pore 114 during sterilization.

[0042] In some examples, indicator 128 may be fluidly connected to internal cavity 110 via sampling port 144. For example, sampling port 144 may define a lumen 146 that fluidly connects internal cavity 110 to cavity 138. Sampling port 144 may be connected to or extend through orifice 140. For example, sampling port 144 may extend from a proximal end connected to orifice 140 of base 132 to a distal end configured to extend into internal cavity 110 of outer shell 104 of sterilization package 100. In some examples, sampling port 144 may include a proximal end defining a disc-shaped portion from which lumen 146 extends to a distal end extending into internal cavity 110. The diameter of the disc-shaped portion may be larger than the diameter of orifice 140. At least a portion of base 132 adjacent to the disc-shaped portion may be configured to engage the disc-shaped portion.

[0043] In some examples, at least a portion of the outer surface of the sampling port 144 may define a neck. The neck of the sampling port 144 may be configured to engage a locking mechanism. This locking mechanism may be configured to secure the sampling port 144 to the housing 104 in a damage-resistant manner. For example, in an example where the housing 104 comprises a rigid container with a removable lid, the sampling port 144 may be positioned to extend through the aperture 140. The locking mechanism may engage the sampling port 144 to secure the sampling port 144 to the lid. Once the lid is closed on the rigid container, the locking mechanism is positioned within the internal cavity 110. Therefore, the sampling port 144 will not detach without opening the rigid container. As discussed above, the sterilization indicator 102 may be adhered to or otherwise secured to the sampling port 144. In this way, the sampling port 144 can be used to secure the sterilization indicator 102 to the outer surface 106 of the housing 104 of the sterilization package 100.

[0044] In some examples, sampling port 144 may include a sterilizing agent-permeable microbial barrier disposed within lumen 146. The sterilizing agent-permeable microbial barrier may be configured to allow sterilizing agent to enter from inner cavity 110 into cavity 138 and prevent microorganisms from entering inner cavity 110 from cavity 138. The sterilizing agent-permeable microbial barrier may comprise one or more materials, such as the flexible materials described above with reference to flexible packaging shell 104. In this way, the sterilizing agent-permeable microbial barrier can reduce potential contamination of inner cavity 110 from sterilization indicator 102.

[0045] In some examples, the distal end of the sampling port 144 may be defined as a sharp tip configured to pierce the outer shell 104. For example, the sharp distal end of the sampling port 144 may be configured to pierce the outer surface 106 of the flexible packaging shell 104. Forming the sampling port 144 as a defined sharp tip allows the sterilization indicator 102 to be secured to the outer shell 104 after the article is encased in the flexible packaging shell 104, by piercing the outer shell 104 with the sampling port 144 and adhering the base 132 to the outer surface 106 of the outer shell 104.

[0046] In some examples, the sterilization indicator 102 may include a seal 142 configured to form a sterilizing agent barrier and / or a microbial barrier between the exterior of the sterilization indicator 102 and the cavity 110 of the sterilization package 100 and / or the cavity 138 of the sterilization indicator 102. The exterior of the sterilization indicator 102 may include, for example, any one or more of the following: surface 124 of the cover 122, surface 134 of the base 132 or another surface of the cover 122, the intermediate layer 130 and / or the base 132 outside the cavity 138. In some examples, the seal 142 may be disposed on the surface of the cover 122 or the base 132. The seal 142 may extend at least around the periphery of the aperture 140 (such as the periphery of the cover 122 and / or the base 132). In an example where the cover 122 is integrally formed with the intermediate layer 130, the seal 142 may be disposed on the lower surface (e.g., surface 126) of the cover 122, such that at least a portion of the edge of the cover 122 is configured to connect with the surface 106 of the outer shell 104 of the sterilization package 100. In an example where the proximal end of the sampling port 144 defines a disc-shaped portion, the seal 142 may be disposed on the disc-shaped portion, for example, between the disc-shaped portion and the outer surface 106 of the outer shell 104.

[0047] The seal 142 may comprise any suitable material configured to form a sterilizing agent barrier and / or a microbial barrier between the exterior of the sterilization indicator 102 and the cavity 110 of the sterilization package 100 and / or the cavity 138 of the sterilization indicator 102. For example, the seal 142 may comprise a pressure-sensitive adhesive, an elastomer material, silicone resin, polytetrafluoroethylene, nitrile rubber, neoprene rubber, EPDM rubber, fluorocarbon, or a combination thereof.

[0048] In some examples, the sterilization indicator 102 may include a process challenge section or part of a process challenge device. The process may be configured to prevent sterilizing agent from entering the cavity 138 from the internal cavity 110 during sterilization. The process challenge may include, for example, a channel fluidly connecting the internal cavity 110 to the cavity 138. This channel may define a tortuous path that, relative to a substantially straight or non-tortuous lumen, slows the movement of the sterilizing agent, thereby limiting the indicator 128's exposure to the sterilizing agent. In some examples, the process challenge section may be configured to indicate the path of the sterilizing agent through one or more lumens of the medical device. In some examples, the lumen 146 of the sampling port 144 may define the process challenge section.

[0049] Figure 2 A to Figure 2 C is a conceptual diagram showing several views of an exemplary sterilization indicator 202. Apart from the differences described herein, the sterilization indicator 202 may be related to the above-mentioned... Figure 1 The sterilization indicator 102 described is the same as or substantially similar to the one described.

[0050] The sterilization indicator 202 includes a cover 222, an indicator 228, an intermediate layer 230, and a base 232. (As mentioned above...) Figure 1 As discussed, the cover 222 and the base 232 extend in substantially parallel planes. At least one of the cover 222 or the base 232 may be integrally formed with, adhered to or otherwise fastened to at least a portion of the intermediate layer 230 in order to define a cavity 238 configured to receive the indicator 228.

[0051] In some examples, the indicator 228 may be adhered to or otherwise secured to the surface of the cover 222 or the surface of the base 232. Figure 2 C). In some examples, indicator 228 may include a coating applied to the surface of cover 222 or the surface of base 232. In some examples, indicator 228 may be removable or replaceable. For example, as Figure 2 As shown in Figure B, the cover 222 may be removable. After removing the cover 222, the indicator 228 (which may include a failed indicator that has been exposed to the sterilizing agent) can be replaced with a new indicator that has not been exposed to the sterilizing agent. In this way, the sterilization indicator 202 can define a housing and a replaceable indicator. By making the indicator 228 replaceable, the indicator 202 can reduce the operating costs of the aseptic processing department compared to using a sterilization indicator without a replaceable indicator.

[0052] Although not in Figure 2 A to Figure 2As shown in Figure C, but in an example where the cover 222 is removable, the cover 222 may be secured to the base 232 and / or the intermediate layer 230 by one or more hinges, clips, or other mechanical fasteners. Additionally, or alternatively, the sterilization indicator 202 may include one or more seals between the cover 222 and the base 232 and / or the intermediate layer 230. These one or more seals may be consistent with those referenced above. Figure 1 The described seal 142 is substantially the same as or similar to the original.

[0053] In some examples, base 232 may include an adhesive underlayer (e.g., opposite the surface of base 232 adjacent to intermediate layer 230 and indicator 228). The adhesive layer of base 232 may be configured to adhere to sterilization packaging (e.g., the outer surface 106 of outer shell 104). For example, the adhesive layer may include pressure-sensitive adhesives, hot melt adhesives, structural adhesives, thermoplastics, thermosetting polymers, epoxy resins, or adhesives suitable for steam, ethylene oxide, dry heat, or vaporized adhesive hydrogen peroxide sterilization procedures and selectively adhered to the outer surface of the sterilization package.

[0054] In examples where the sterilization package includes flexible packaging, the adhesive may be selected to migrate into the flexible material of the flexible packaging during sterilization. Migration may include: a first portion of the adhesive remaining adhered to the base 232 and the outer surface of the flexible packaging, while a second portion of the adhesive moves through the flexible material (e.g., between the fibers of the flexible material) toward the inner surface of the flexible packaging. In this way, compared to a sterilization indicator 202 that includes adhesive that does not migrate into the flexible material of the flexible packaging during sterilization, this adhesive can form a more impermeable barrier to the sterilizing agent and a more impermeable barrier to microorganisms (e.g., between the outside and inside of the flexible packaging). Additionally, or alternatively, the adhesive may prevent the sterilizing agent from entering the cavity 238 merely across the flexible material of the flexible packaging, or at least reduce the amount of the sterilizing agent. That is, the adhesive may force the sterilizing agent from the inner cavity of the flexible packaging into the cavity 238 via the pores 240 of the base 232.

[0055] Figure 3 A and Figure 3 B is a conceptual perspective view showing an exemplary process challenge device 300 including a sterilization indicator 302 comprising a process challenge section 350. Except for the differences described herein, the sterilization indicator 302 may be related to the above references. Figures 1 to 2The sterilization indicators 102 and / or 202 described in C are identical or substantially similar. The process challenge unit 350 is configured to restrict the flow of sterilizing agent to indicator 328 using a tortuous path from the orifice 340 of the base 332 to the cavity 338. This tortuous path can be configured to represent the path of the sterilizing agent through one or more lumens of the medical device. For example, an endoscope typically includes a long, narrow channel through which the sterilizing agent must pass to expose all surfaces to the sterilizing agent for a sufficient time to induce sterilization. The tortuous path of the process challenge unit 350 can be configured to represent the path of the sterilizing agent through the long, narrow channel of the endoscope.

[0056] In some examples, the process challenge portion 350 may be integrally formed with one or more components of the process challenge device 300, such as the sterilization indicator 302. For example, the process challenge device sterilization indicator 302 includes a cover 322, a first intermediate layer 330 adjacent to the cover 322, a second intermediate layer 331, and a base 332 adjacent to the second intermediate layer 331. At least one of the cover 322, the first intermediate layer 330, the second intermediate layer 331, or the base 332 may define a cavity 352, which includes a tortuous path from the aperture 340 of the base 332 to the cavity 332. In some examples, the cavity 352 may be formed in at least one of the cover 322, the first intermediate layer 330, the second intermediate layer 331, or the base 332 by milling, laser etching, photolithography, or subtractive manufacturing techniques suitable for use with the material of the challenge device 300 and the required disassembly of the cavity 352. In other examples, the process challenge section 350 may be formed separately from and attached to the process challenge device 300. For example, the process challenge section 350 may be adhered to or otherwise mechanically coupled to the sterilization indicator 302 to fluidly connect the pores 340 to the internal cavity of the housing.

[0057] like Figure 3 A and Figure 3 As shown in Figure B, the second intermediate layer 331 may define a cavity 352, while the first intermediate layer 330, together with the cover 322 and the second intermediate layer 331, may define a cavity 338. The tortuous path of the cavity 352 may include any suitable shape. For example, the shape of the tortuous path may include a serpentine shape, one or more necks or tapering portions, or a zigzag shape. The cavity 352 may extend entirely within the plane defined by the cover 322, the first intermediate layer 330, the second intermediate layer 331, or the base 332, or it may extend between two or more of the cover 322, the first intermediate layer 330, the second intermediate layer 331, or the base 332.

[0058] In some examples, the process challenge unit 350 may include a heat transfer modulator adjacent to the indicator 328. This heat transfer modulator may be configured to slow the rate at which the indicator 328 reaches a given sterilization process temperature. The heat transfer modulator may be integrally formed with at least a portion of the process challenge device 300 (e.g., base 332, or a separate component that may be attached to or added to from the process challenge device 300). In some examples, at least a portion of the heat transfer modulator may surround at least a portion of the indicator 328. In some examples, the heat transfer modulator may prolong the time required for sufficient contact of the sterilizing agent with the indicator, at least with respect to the temperature of the sterilization conditions, to produce an indication that sterilization conditions have been met.

[0059] In some examples, process challenge section 350 and / or cavity 338 may include a selected volume of gas, such as air, nitrogen, carbon dioxide, or another inert gas. The gas volume contained within process challenge section 350 and / or cavity 338 can provide resistance to the sterilizing agent to at least partially aid the operation of process challenge section 350. This resistance may be related to the sterilization of various products and articles and their quantities. In some examples, gas displacement may allow the sterilizing agent to fill cavity 338 and contact indicator 328.

[0060] In some examples, the process challenge device 300 may include an opening in fluid communication with an internal cavity of the housing, allowing condensate to exit the cavity 338. Additionally, or alternatively, the process challenge device 300 may include absorbent material within the cavity 338 (e.g., adjacent to the indicator 328). This absorbent material may be configured to absorb condensate. Reducing the amount of condensate (if present) that may come into contact with the indicator 328 increases the reproducibility of the indicator 328 in indicating whether sterilization conditions have been met or not.

[0061] Figure 4 This is a conceptual diagram illustrating an exemplary sterilization package 400, which includes a sterilization indicator 402 positioned on the outer surface of a housing 104. Apart from the differences described herein, the sterilization indicator 402 may be related to the above-described sterilization indicators. Figures 1 to 3 The sterilization indicators 102, 202, 302 and / or process challenge device 300 described in B are the same as or substantially similar to those in B.

[0062] The outer casing 404 defines an internal cavity 410. The sterilization indicator 402 includes a cover 422 and a base 432 adjacent to the indicator 428, and an intermediate layer 430 extending between the cover 422 and the base 432. The intermediate layer 430 may define a cavity 438 configured to receive at least a portion of the indicator 428. The indicator 428 (e.g., cavity 438) may be fluidly connected to the internal cavity 410 through a lumen 446 defined by a sampling port 444 and an aperture 440 defined by the base 432. The sampling port 444 may be tapered. During sterilization, a sterilizing agent may move from the sterilization chamber into the internal cavity 410, as indicated by the dashed arrow 420. The sterilizing agent may also move from the internal cavity 410 into the sterilization indicator 402.

[0063] Figure 5 This is a conceptual diagram showing a perspective view of an exemplary sterilization indicator 502. Apart from the differences described herein, the sterilization indicator 502 may be related to the above-mentioned... Figures 1 to 4 The sterilization indicators 102, 202, 302, 402 and / or process challenge device 300 described are the same or substantially similar.

[0064] The sterilization indicator 502 includes a cover 522, an indicator 528, and a seal 532. In some examples, the sterilization indicator 502 may include an intermediate layer, as discussed above. At least one of the cover 522 or the base 532 may define a cavity 538 configured to receive the indicator 528. The cover 522 may be in a closed position and as... Figure 5 The indicator 528 can be moved between open positions as shown. For example, after opening the cover 522, the indicator 528 (which may include a failed indicator that has been exposed to the sterilizing agent) can be replaced with a new indicator that has not been exposed to the sterilizing agent. By making it possible to replace the indicator 528, the sterilization indicator 502 can be secured to the sterilization package.

[0065] In some examples, sampling port 544 may include a proximal end 547 defining a disc-shaped portion 545, from which a lumen 546 extends to a distal end 549, which extends into the internal cavity 110. The diameter of the disc-shaped portion may be larger than the diameter of the aperture 540. At least a portion of the base 532 adjacent to the disc-shaped portion may be configured to engage the disc-shaped portion 545.

[0066] Figure 6 A and Figure 6 B is a conceptual diagram showing a perspective view of an exemplary sterilization indicator 602. Apart from the differences described herein, the sterilization indicator 602 may be related to the above-mentioned... Figures 1 to 5 The sterilization indicators 102, 202, 302, 402, 502 and / or process challenge device 300 described are the same or substantially similar.

[0067] The sterilization indicator 602 defines the orifice 640 and the cavity 638. For example... Figure 6 As shown in Figure B, the pore 640 is configured to fluidly connect the cavity 638 to the internal cavity of the outer shell 604 of the sterilization package 600. For example, the shape and size of the pore 640 may be selected to be the same as or substantially similar to the shape and size of the lumen of the sampling port, and / or selected to be locatable on one or more pores 614 defined by the outer shell 604. The cavity 638 is configured to receive the indicator 628. As discussed above, the sterilization indicator 602 may include a multilayer laminated structure comprising multiple polymer films housing the indicator 628 within the cavity 638, through which the sterilizing agent can only enter the cavity via the pore 640 through the sampling port.

[0068] Figure 7 This is a conceptual plan view showing a portion of an exemplary sterilization package 700, which includes a sterilization indicator 702. Apart from the differences described herein, the sterilization indicator 702 may be related to the above-mentioned... Figures 1 to 6 The sterilization indicators 102, 202, 302, 402, 502, 602 and / or process challenge device 300 described in B are the same as or substantially similar to those in B.

[0069] For example, sterilization package 700 includes a housing 704 defining a plurality of pores 714. A sterilization indicator 702 is located on the housing 704. The sterilization indicator 702 includes two flexible polymer films. The peripheral edges of the two flexible polymer films can be sealed together, for example, as described above, to form a clamshell configuration. This clamshell configuration may define a cavity 738 configured to receive the indicator 728. The pores 740 are configured to allow fluid communication between the cavity 738 and an internal cavity of the housing 704. In some examples, the clamshell configuration of the sterilization indicator 702 may be less expensive and / or less time-consuming to manufacture compared to other sterilization indicators, such as those with a laminated structure.

[0070] Figure 8 A to Figure 8 E is a conceptual diagram illustrating exemplary components of sterilization package 800. Apart from the differences described herein, sterilization package 800 may be identical or substantially similar to sterilization packages 100, 400, 600, and / or 700. For example, sterilization package 800 may include one or more components of sterilization indicators 102, 202, 302, 402, 502, 602, 702, and / or the sterilization indicator of process challenge device 300.

[0071] like Figure 8 As shown in Figure A, the sampling port 844 includes an elongated tube 843 and a disc-shaped portion 845. The sampling port 844 extends from a proximal end 847 to a distal end 849. The proximal end 847 includes the disc-shaped portion 845, from which the elongated tube 843 extends to the distal end 849.

[0072] An elongated tube 843 defines a lumen 846 and a neck 851. The lumen 846 is configured to extend into the internal cavity of the outer shell 804 of the sterilization package 800. The neck 851 is configured to engage a locking mechanism 860, such as... Figure 8 As shown in B.

[0073] In some examples, the locking mechanism 860 may include a frame 862. For example... Figure 8 As shown in Figure C, the frame 862 can be configured to secure a sterilizing agent-permeable microbial barrier 870 (filter 870) to a portion of the housing 804. For example, when the frame 862 engages with the inner surface of the housing 804, it can secure the filter 870 to a sterilizing agent-permeable region 812 of the defined pores 814 of the housing 804. Figure 8 E). In this way, frame 862 enables housing 804 to define one or more sterile-permeable but microbial-impermeable pathways from the outside to the inside of housing 804.

[0074] like Figure 8 As shown in Figure B, a locking mechanism 860 may define an orifice 864. The orifice 864 is configured to receive at least a portion of an elongated tube 843 of a sampling port 844 through it. For example, the elongated tube 843 may pass through the orifice 864 until a neck 851 engages a locking member 866 of the locking mechanism 860. In some examples, the locking member 866 may include one or more protrusions formed to fit within the neck 851. The locking mechanism 860 may include one or more springs coupled to the locking member 866. One or more springs may be configured to push the locking member 866 into a locking configuration. For example, the locking configuration may include a position where the locking member 866 engages the neck 851 of the sampling port 844. In some examples, the locking mechanism may include one or more levers 868 mechanically coupled to a corresponding locking member 866. The levers 868 may be configured to move the locking member 866 from a locking configuration to an open configuration. The open configuration may include a position where the elongated tube 843 passes through the locking member 866 of the orifice 864. For example, as... Figure 8 As shown in D, the rod 868 can be manipulated to insert the elongated tube 843 into the aperture 864 of the locking mechanism 860, and / or to disengage the locking member 866 from the neck 841.

[0075] In some examples, the disc-shaped portion 845 may define a recess configured to receive a seal, such as an O-ring seal 853. The seal 853 may be configured to provide a sterilizing barrier and / or a microbial barrier between the exterior and interior of the housing 804 when engaged, for example, by a locking mechanism 860. In some examples, the locking mechanism 860 may be configured to engage with the neck 851 when the O-ring seal 853 is compressed to an amount sufficient to form a sterilizing barrier and / or a microbial barrier.

[0076] Figure 8 E is a plan view of the sterile agent-permeable region 812 of the housing 804 and the disc-shaped portion 845 of the sampling port 844, the sterile agent-permeable region defining a pore 814, the disc-shaped portion engaging with the outer surface of the housing 804 as described above. In this way, the locking mechanism 860, the elongated tube 843, and the seal 853 allow sterile agent to travel from the interior of the housing 804 to the sterilization indicator and reduce or prevent sterile agent from traveling from a point on the exterior of the housing 804 to the interior of the housing 804. Additionally, or alternatively, by positioning the locking mechanism 860 inside the housing 804, the sampling port 844 and the microbial barrier 870 can be disengaged only when the cover of the housing 804 is removed (e.g., during instrument setup in surgical procedures).

[0077] As discussed above, in some examples, sterilization indicators can be adhered to the surface of a flexible sterilization package. Figure 9 is a conceptual perspective view of a flexible sterilization package 900, which includes a plurality of sterilization indicators 902A and 902B (collectively, sterilization indicators 902) adhered to the outer shell 904 of the sterilization package 900. Apart from the differences described herein, the sterilization package 900 may be identical or substantially similar to sterilization packages 100, 400, 600, 700, and / or 800. For example, the sterilization package 900 may include one or more components of sterilization indicators 102, 202, 302, 402, 502, 602, 702, 802, and / or process challenge device 300.

[0078] The housing 904 includes a folded flexible material that is taped at seams to define an internal cavity 910. As discussed above, the housing 904 may define a microbial barrier permeable to sterilizing agents between the internal cavity 910 and the sterilization chamber 918 (e.g., outside the housing 904). A sterilization indicator 902 is configured to adhere to an outer surface 906 of the housing 904. For example, as shown in cross-section, the sterilization indicator includes a cover 922 and a base 932 configured to hold the indicator 928. The base 932 includes an adhesive layer 933 located on a surface of the base 932 adjacent to the housing 904. The adhesive 933 may be configured to migrate at least partially through the flexible material of the housing 904. For example, the adhesive layer 933 may be configured to migrate into the flexible material of the housing 904 upon exposure to heat, moisture, or pressure. At least a first portion of the adhesive layer 933 may remain adhered to the base 932 and the outer surface 906 of the housing 904. At least a second portion of the adhesive layer 933 may migrate toward the inner surface 908 of the housing 904 into the flexible material (e.g., between the fibers of the flexible material). In this way, compared to a sterilization indicator 902 which includes an adhesive that does not migrate into the flexible material of the housing 904 before or during the sterilization process, the adhesive layer 933 may be configured to form a barrier that is more impermeable to the sterilizing agent and a barrier that is more impermeable to microorganisms (e.g., between the outer 918 of the housing 904 and the inner cavity 910). Additionally, or alternatively, the adhesive may prevent the sterilizing agent from contacting the indicator 928 by merely traversing the flexible material of the housing 904 without first entering the cavity 910, or at least reduce the amount of the sterilizing agent.

[0079] Figure 10 is a flowchart illustrating an exemplary technique for forming a sterilization indicator. While the technique shown in Figure 10 will be referenced to... Figure 1 The sterilization indicator 102 is described in the description, but the technique can be used to form other sterilization indicators, such as any one or more of sterilization indicators 202, 302, 402, 502, 602, 702, 802, 902 and / or process challenge device 300.

[0080] The technique shown in Figure 10 includes a cover 122 (1002) forming at least a portion of a cavity 138. In some examples, the sterilization indicator 102 may include a laminated structure including, for example, a cover 122, an intermediate layer 130, and a base 132. In examples where the sterilization indicator includes a laminated structure, forming the cover 122 may include laminating the base 132 onto the cover 122, or laminating one or more intermediate layers 130 onto the cover 122 and laminating the base 132 onto one or more intermediate layers 130. As used herein, lamination may include securing at least a portion of two or more layers by adhesive, ultrasonic welding, thermal welding, or other suitable fastening techniques.

[0081] In some examples, forming the cover 122 may include molding the cover 122. For example, molding may include injection molding, vacuum forming, or other molding processes to produce a cover 122 of a selected shape. For example, molding the cover 122 may include molding the cover 122 to define at least a portion of the cavity 138. In some examples, forming the cover 122 may include molding one or more of an intermediate layer 130 and a base layer 132.

[0082] In some examples, forming the cover 122 may include removing material from the cover 122. Removing material from the cover 122 may include, for example, milling, laser etching, chemical etching, or other substantial manufacturing techniques. For example, forming the cover 122 may include processing at least a portion of the cover 122 to form at least a portion of the cavity 138. In some examples, forming the cover 122 may include laser etching at least a portion of the cover 122, the intermediate layer 130, and / or the base 132 to form one or more process challenge portions (e.g., process challenge portion 350). In some examples, forming the cover 122 may include removing material from the intermediate layer 130, for example, to define the cavity 138, and / or removing material from the base 132, for example, to define the aperture 140.

[0083] The technique shown in Figure 10 may include positioning an indicator 128 within a cavity 138 (1004). Positioning the indicator 128 may include positioning the indicator 128 into the cavity 138, or in the location of the cavity 138, before or after forming the cover 122 and / or the cavity 138. In some examples, positioning the indicator 128 within the cavity 138 may include placing the indicator 128 into the cavity 138, or in the location of the cavity 138, without adhering or otherwise securing the indicator 128 within the cavity 138. In some examples, positioning the indicator 128 within the cavity 138 may include removing the cover 122, positioning the indicator 128 within the cavity 138, and returning the cover 122. In some examples, positioning the indicator 128 within the cavity 138 may include adhering the indicator 128 to the surface 126 of the cover 122, the surface 134 of the base 132, or the surface of the intermediate layer 130. In examples where the indicator 128 includes a coating, positioning the indicator 128 may include coating the surface 126 of the cover 122, the surface 134 of the base 132, or the surface of the intermediate layer 130. As used herein, coating to position the indicator 128 may include any suitable coating process, such as, for example, spraying, brushing, inkjet printing, or other additive manufacturing processes.

[0084] The technique shown in Figure 10 may include: providing a seal 142 (1006) adjacent to the cover. Providing the seal 142 may include: applying an adhesive or elastic material to the surface of one or more of the cover 122, the intermediate layer 130, or the base 132. In some examples, providing the seal 142 may include: applying an adhesive or elastic material to the surface of the sampling port 144.

[0085] In some examples, the technique may include forming a sampling port 144. Forming the sampling port 144 may include any suitable additive manufacturing process (e.g., 3D printing) and / or subtractive manufacturing process (e.g., milling or machining) to form the sampling port 144. In some examples, forming the sampling port 144 may include positioning a seal 142 on at least a portion of the sampling port 144. In some examples, forming the sampling port 144 may include positioning a sterilizing agent-permeable microbial barrier within the lumen 146 of the sampling port 144. In examples where the sampling port 144 includes a sharp distal end, forming the sampling port 144 may include removing material to define the sharp distal end. In examples where the sampling port 144 includes a proximal disc (e.g., disc 845) and an elongated tube (e.g., elongated tube 843), the disc 845 may be integrally formed with the elongated tube 843, or formed separately and subsequently fixed, for example, using adhesives, welding, etc. In an example where the sampling port 144 includes a neck (e.g., neck 851), forming the sampling port 144 may include forming the neck 841 by, for example, removing material from the elongated tube 843.

[0086] In some examples, the technique may further include forming a housing 104 including at least one sterilizing agent-permeable region 112. In some examples, the technique may further include positioning a sterilization indicator 102 on at least a portion of the sterilizing agent-permeable region 112. In examples where the housing 104 comprises a flexible package, positioning the sterilization indicator 102 on the housing 104 may include adhering the sterilization indicator 102 to an outer surface 106 of the housing 104. In examples where the sterilization indicator 102 includes a sharp distal end, positioning the sterilization indicator 102 may include piercing the housing 104 with the sharp distal end. In examples where the housing 104 comprises a rigid container, positioning the sterilization indicator 102 may include extending at least a portion of a sampling port 144 through a perforation 140 of the housing, and in some examples, engaging a neck 851 with a locking mechanism (e.g., locking mechanism 860) to secure the sampling port 144 to the housing 104.

[0087] Figure 11 is a flowchart illustrating an exemplary technique using a sterilization indicator. While the technique shown in Figure 11 will be referenced to... Figure 1The sterilization package 100 is described in the description, but the technology can be used with other sterilization packages and sterilization indicators, such as any one or more of sterilization indicators 202, 302, 402, 502, 602, 702, 802, 902 and / or process challenge device 300.

[0088] The technique shown in Figure 11 includes positioning a sterilization indicator 102 on an outer surface 106 of a housing 104 (1102). At least a portion of the outer surface 106 includes a sterilizing agent permeable region 112. In an example where the housing 104 comprises a flexible package, positioning the sterilization indicator 102 on the housing 104 may include adhering the sterilization indicator 102 to the outer surface 106 of the housing 104. In an example where the sterilization indicator 102 includes a sharp distal end, positioning the sterilization indicator 102 may include piercing the housing 104 with the sharp distal end. In an example where the housing 104 comprises a rigid container, positioning the sterilization indicator 102 may include extending at least a portion of a sampling port 144 through a perforation 140 of the housing, and in some examples, engaging a neck 851 with a locking mechanism (e.g., locking mechanism 860) to secure the sampling port 144 to the housing 104.

[0089] The technique shown in Figure 11 includes exposing the sterilization indicator 102 and housing 104 to at least one of a selected duration, a selected temperature, or a selected sterilization agent concentration (1104). In some examples, exposing the sterilization indicator 102 to the sterilization agent may include removing air from the sterilization chamber 118 using a vacuum. Exposing the sterilization indicator 102 to the sterilization agent includes introducing the sterilization agent into the cavity 110 (e.g., as indicated by arrow 120) such that the sterilization agent travels via the lumen 146 into the cavity 138 (e.g., as indicated by arrow 121). In some examples, at least one of the selected duration, selected temperature, or selected sterilization agent concentration may be based at least in part on one or more of the types of articles to be sterilized, common sterilization practices, the type of housing 104 (e.g., rigid container or flexible packaging), the type of sterilization agent, etc.

[0090] The technique shown in Figure 11 includes determining, via indicator 128, whether the internal cavity 110 of housing 104 is exposed to at least one of a threshold exposure duration, a threshold sterilizing agent temperature, or a threshold sterilizing agent concentration (1106). In some examples, determining the exposure of indicator 128 may include comparing a color change of indicator 128 with a legend or symbol illustration. For example, a threshold color change of indicator 128 may indicate at least one of a threshold exposure duration, a threshold sterilizing agent temperature, or a threshold sterilizing agent concentration. In some examples, the indication may include, for example, a change in an electrical signal, a change in an optical signal, or a change in a physical phenomenon. In this way, determining the exposure of indicator 128 may include determining, via a processing circuitry system coupled to indicator 128, whether the internal cavity 110 of housing 104 is exposed to at least one of a threshold exposure duration, a threshold sterilizing agent temperature, or a threshold sterilizing agent concentration based on a change in an electrical or optical signal.

[0091] Various embodiments of the present invention have been described. These and other embodiments are within the scope of the following claims.

Claims

1. A sterilization indicator, the sterilization indicator comprising: A cover portion, the cover portion defining at least a portion of the cavity, and including a cover portion layer; An indicator disposed within the cavity and comprising an indicator layer disposed on a cover layer of the cover portion, wherein the indicator is configured to be fluidly connected to the internal cavity of the sterilization package and to indicate exposure to a sterilizing agent; and A seal configured to form a microbial barrier between the exterior of the cover and the cavity of the sterilization package; The base defines a second surface opposite the cover layer of the cover, the second surface including pores; A sampling port, the sampling port comprising an elongated tube having a proximal end connected to the pore and a distal end disposed in the internal cavity of the sterilization package, such that the indicator is fluidly connected to the internal cavity of the sterilization package; The indicator layer is smaller in size than the base, and the edge of the base extends beyond the indicator, and at least a portion of the edge of the base is connected to at least a portion of the edge of the cover.

2. The sterilization indicator of claim 1, wherein the indicator is configured to provide an indication of the effectiveness of the sterilization procedure.

3. The sterilization indicator of claim 1, further comprising a release liner, wherein the cover is peripherally coupled to the release liner such that the indicator is disposed between the release liner and the cover.

4. The sterilization indicator of claim 1, wherein the seal is disposed on the surface of the cover, and wherein at least a portion of the cover is configured to be connected to the outside of the sterilization package.

5. The sterilization indicator of claim 1, wherein the indicator is smaller in size than the cover, and the edge of the cover extends beyond the indicator.

6. The sterilization indicator according to claim 5, wherein the sterilization indicator further comprises at least one intermediate layer disposed between the cover and the indicator, and wherein the at least one intermediate layer comprises at least one of a sterilizing agent impermeable layer, an adhesive layer, or a color-enhancing layer.

7. The sterilization indicator of claim 6, wherein at least a portion of the intermediate layer is configured to be externally coupled to the sterilization package.

8. The sterilization indicator of claim 1, wherein the distal end defines a sharp tip configured to pierce the outer surface of the sterilization package.

9. The sterilization indicator of claim 1, wherein the proximal end of the sampling port defines a disc-shaped portion, the disc-shaped portion being configured to engage with the second surface of the base, and wherein the seal is disposed between the disc-shaped portion and the exterior of the sterilization package.

10. The sterilization indicator of claim 1, wherein the outer surface of the sampling port defines a neck, the neck being configured to engage a locking mechanism of the sterilization package to secure the sterilization indicator to the outer surface of the sterilization package.

11. The sterilization indicator of claim 1, wherein the sampling port includes a sterilizing agent-permeable microbial barrier disposed within the sampling port.

12. The sterilization indicator of claim 1, further comprising a process challenge device configured to block the sterilizing agent from passing through the sampling port.

13. The sterilization indicator of claim 1, wherein the indicator comprises at least one of a chemical indicator or a biological indicator.

14. The sterilization indicator of claim 1, further comprising a process challenge device defining a channel for fluidly connecting the indicator to the internal cavity of the sterilization package, wherein the process challenge device is configured to block the sterilizing agent from passing through the channel.

15. A sterilization package, said sterilization package comprising: A housing having an outer surface and defining an internal cavity, wherein at least a portion of the housing includes a sterilizing agent permeable region; and The sterilization indicator according to claim 1.

16. The sterilization package of claim 15, wherein the outer shell comprises a flexible, sterilizing agent-permeable microbial barrier material.

17. The sterilization package of claim 15, wherein the outer shell comprises a rigid container, and wherein at least a portion of the rigid container defines an aperture for fluidly connecting the indicator to the internal cavity.

18. A method, the method comprising: The sterilization indicator as described in claim 1 is positioned on the outer surface of a housing, the housing defining an internal cavity, wherein at least a portion of the outer surface includes a sterilizing agent permeable region; The sterilization indicator and the housing are exposed to the sterilizing agent for at least one of a selected duration, a selected temperature, or a selected sterilizing agent concentration. The indicator determines whether the internal cavity of the housing is exposed to at least one of a threshold exposure duration, a threshold sterilizing agent temperature, or a threshold sterilizing agent concentration.

Images