Sterilization indicator reading apparatus with color detection

Abstract

The present disclosure provides embodiments of a sterilization indicator reading apparatus. The sterilization indicator reading apparatus includes a plurality of wells disposed in a housing configured to receive a plurality of biological indicators. Each well includes a first region spaced apart from a second region. A heater is thermally coupled with each well. The housing further includes a printed circuit board including a plurality of fluorescent excitation sources, plurality of white light sources, and plurality of color sensors. A first fluorescent excitation source, first white light source, and a first color sensor are disposed in the first region. A second white light source and a second color sensor are disposed in the second region. The printed circuit board further includes a processor and a memory. The processor is communicatively coupled with the heaters, the plurality of fluorescent excitation sources, plurality of white light sources, and plurality of color sensors.

Description

PA200030W002STERILIZATION INDICATOR READING APPARATUS WITH COLORDETECTIONBACKGROUND

[0001] In many industries it may be necessary to monitor the effectiveness of sterilization processes. Specifically in the health care industry, monitoring effectiveness of sterilizing equipment such as medical devices, instruments, and other disposable and non-disposable articles is of particular importance. A sterilization process is defined as the process of destroying all viable sources of biological activity, such as microorganisms including viruses and spores.

[0002] As a standard practice, hospitals, for example, may include a sterilization indicator with a batch of articles to assess the lethality of the sterilization process. Both biological and chemical sterilization indicators have been used.

[0003] Available chemical sterilization indicators may be read immediately after a sterilization process. The results, however, merely indicate the sterilization process at that particular time and the presence of a particular chemical or a temperature. In contrast, the response of sources of biological activity to all conditions actually present after the sterilization process may be a more direct and reliable test for the effectiveness of a sterilization process.

[0004] A standard type of biological indicator includes a known quantity of test microorganisms, for example Geobacillus stearothermophilus spores or Bacillus atrophaeus spores, which are more resistant to sterilization processes than other organisms. After the biological indicator is exposed to the sterilization process, the sources of biological activity (for example, spores) can be incubated to determine whether any of the sources of biological activity survived the sterilization process by measuring the source metabolism and / or growth indicating the sterilization process was effective in destroying all the sources of biological activity.

[0005] Measuring the biological indicator with a sterilization indicator reading apparatus is advantageous to determine the effectiveness of a sterilization process in a reliable and timely manner. Specifically, a sterilization indicator reading apparatus that uses user input to automatically heat, read, and produce results of the biological indicator is particularly advantageous.

[0006] Sterilization indicator reading apparatuses may use a photodiode to determine the fluorescence response of the biological indicator spores, as described in U.S. Pat. No. 9,410,180,which is incorporated by reference herein. Some sterilization indicator reading apparatuses may use a color sensor to determine whether the sterilization indicator is activated in the biological indicator.

[0007] Sterilization indicator reading apparatuses may include multiple wells to evaluate biological indicators at the same time. However, some biological indicator spores may require a preset incubation heating profde or time within the sterilization indicator reading apparatus. It may be difficult to keep track of multiple biological indicators in the sterilization indicator reading apparatus, especially when the samples are in the same or similar containers. Some sterilization indicator reading apparatuses use bar codes or colored caps to determine what biological indicator is in a particular well. However, this may not remove human error. The user must identify the correct a biological indicator, in each sample to apply the correct bar code or colored cap. Furthermore, if the sterilization indicator reading apparatus is using a colored cap to determine the type of biological indicator this does not allow the user to label the sample, thus introducing the possibility of error. If a user labels the colored cap, the cap may not be effective for identification by the sterilization indicator reading apparatus when covered by a sample label. In addition, a user may remove and replace a different colored cap, which may result in an error.

[0008] In addition, some sterilization indicator reading apparatuses may require an extended time to heat up the biological indicator, thus delaying results of a sterilization process. Some sterilization indicator reading apparatuses may take over thirty minutes to heat the sample to a desired temperature.SUMMARY

[0009] The present disclosure provides a sterilization indicator reading apparatus configured to authenticate a color indicator sealed within a biological indicator. In response to affirmative authentication, the sterilization indicator reading apparatus provides a method to determine the effectiveness of a sterilization process the biological indicator was exposed to.

[0010] In one or more embodiments, the present disclosure provides a sterilization indicator reading apparatus. In one embodiment of the present disclosure, the sterilization indicator reading apparatus includes a plurality of wells disposed in a housing configured to receive a plurality of biological indicators. A heater is thermally coupled with each well. The housing further includes a printed circuit board including a plurality of fluorescent excitation sources, plurality of white light sources, and plurality of color sensors. The printed circuit board further includes a processor and a memory. The processor is communicatively coupled with the heaters, the plurality of fluorescent excitation sources, plurality of white light sources, and plurality of color sensors.

[0011] It may be desirable for a sterilization indicator reading apparatus to determine whether there is a biological indicator present in the well to provide feedback to the user (for example, whichsamples are positioned properly and currently being evaluated by the apparatus). It may be desirable for a sterilization indicator reading apparatus to determine whether a biological indicator is activated in a well during the incubation process (for example, to provide feedback to the user and eliminate wasted time due to an inactive biological indicator). It may be desirable for a sterilization indicator reading apparatus to run a preset heating profde based on the color of the color indicator corresponding to a type of biological indicator to improve reliability (for example, entering the wrong heating profile or biological indicator type in the sterilization indicator reading apparatus). It may be desirable for a sterilization indicator reading apparatus to reduce time to heat the biological indicator thus reducing time to obtain results. It may be desirable for a sterilization indicator reading apparatus to determine whether the biological indicator used is an authentic article to ensure or warrant reliability of the sterilization reading.

[0012] In one or more embodiments of the present disclosure a sterilization indicator apparatus includes a housing which includes atop portion, a bottom portion opposite the top portion, and a side portion. The housing further includes a well disposed into the housing and oriented along a well axis extending from a well open end to a well bottom end. The well includes a first region and a second region. The first region and the second region are spaced apart along the well axis and the well is configured to receive at least a portion of a biological indicator. The housing includes a heater thermally coupled to the well configured to heat the well. Disposed in the housing is a first printed circuit board aligned with the well axis. The first printed circuit board includes a first fluorescence excitation source, a first white light source, a first color sensor, a second fluorescence excitation source, a second white light, and a second color sensor. The first fluorescence excitation source and the first white light source are configured to direct light into the first region of the well. The first color sensor is configured to measure the fluorescence and detect the color in the first region of the well. The first fluorescent excitation source, the first white light source, the first color sensor are on the first printed circuit board adjacent to the first region. The second white light source is configured to direct white light into the second region in the well. The second color sensor is optically communicative within the second region in the well. The second white light source and the second color sensor are on the first printed circuit board adjacent to the second region. The first printed circuit board further includes a controller circuit. The controller circuit includes a processor and a memory. The processor is communicatively coupled to the heater, the first fluorescence excitation source, the first white light source, the first color sensor, the second white light source, and the second color sensor.

[0013] In one or more embodiments of the present disclosure, a sterilization indicator system includes the sterilization indicator apparatus described herein and a biological indicator. The biological indicator may be received at least partially within the well of the sterilization indicator reading apparatus. The biological indicator includes a transparent outer tube, an ampoule within the transparent outer tube containing a fluorescently responsive substance, a breaker element disposedwithin the transparent outer tube and at least partially surrounding the ampoule. The breaker element includes a color indicator and is optically communicative with the second color sensor and the second white light source of the sterilization indicator reading apparatus. The breaker element is further aligned with the second region of the well. The biological indicator further includes a plurality of spores within the transparent outer tube that are aligned with the first region of the well.

[0014] In one or more embodiments of the present disclosure, a method of using the sterilization indicator system includes disposing a biological indicator in the well of the sterilization indicator reading apparatus. Next, the system activates the white light source to reflect the color of the breaker element color indicator to the second color sensor of the sterilization indicator reading apparatus. The system communicates a color indicator reading value of the second color sensor to the controller of the sterilization indicator reading apparatus and activates a preset heating profile in response to the color indicator reading value of the second color sensor.

[0015] Some advantages of the sterilization indicator reading apparatus the present disclosure provides are determining whether there is a biological indicator present in the well to provide feedback to the user (for example, which samples are positioned properly and currently being evaluated by the apparatus) and determining whether a biological indicator is activated in a well during the incubation process (for example, to provide feedback to the user and eliminate wasted time due to an inactive biological indicator).

[0016] Some further advantages the sterilization indicator reading apparatus the present disclosure provides are determining a run a preset heating profile based on the detected color value of the breaker element color indicator corresponding to a type of biological indicator to improve reliability, for example, entering the wrong heating profile or biological indicator type in the sterilization indicator reading apparatus, reducing the time to heat the biological indicator, and determining whether the biological indicator used is an authentic article to ensure reliability of the sterilization reading.

[0017] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of any text that follows the heading, unless so specified.

[0018] The terms “comprises” and variations thereof do not have a limiting meaning where these terms appear in the description and claims. Such terms will be understood to imply the inclusion of a stated step or element or group of steps or elements but not the exclusion of any other step or element or group of steps or elements.

[0019] The words “preferred” and “preferably” refer to embodiments of the disclosure that may afford certain benefits, under certain circumstances; however, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferredembodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure.

[0020] In this application, terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terms “a,” “an,” and “the” are used interchangeably with the term “at least one.” The phrases “at least one of’ and “comprises at least one of’ followed by a list refers to any one of the items in the list and any combination of two or more items in the list.

[0021] As used herein, the term “or” is employed in its usual sense including “and / or” unless the content clearly dictates otherwise.

[0022] The term “and / or” means one or all of the listed elements or a combination of any two or more of the listed elements.

[0023] As used herein in connection with a measured quantity, the term “about” refers to that variation in the measured quantity as would be expected by the skilled artisan making the measurement and exercising a level of care commensurate with the objective of the measurement and the precision of the measuring equipment used. Herein, “up to” a number (for example, up to 50) includes the number (for example, 50).

[0024] Also herein, the recitations of numerical ranges by endpoints include all numbers subsumed within that range as well as the endpoints (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0025] These and other embodiments of the present disclosure will be apparent from the detailed description below. In no event, however, should the above summaries be construed as limitations on the claimed subject matter, which subject matter is defined solely by the attached claims, as may be amended during prosecution.BRIEF DESCRIPTION OF DRAWINGS

[0026] Throughout the specification, reference is made to the appended drawings, where like reference numerals designate like elements, and wherein:

[0027] FIG. 1 is a perspective view of an embodiment of a sterilization indicator reading apparatus;

[0028] FIG. 2A is a perspective view of the embodiment of the sterilization indicator reading apparatus of FIG. 1 with the side portion of the housing removed;

[0029] FIG. 2B is a perspective view of a well from the sterilization indicator reading apparatus of FIGS. 1 to 2A;

[0030] FIG. 3 is a schematic side-elevation view of the sterilization indicator reading apparatus of FIGS. 1 to 2B;

[0031] FIG. 4A is a side view of an embodiment of a biological indicator that has not been activated (for example, the fluorescently activated substrate and spores are not in fluid contact);

[0032] FIG. 4B is a side view of the embodiment of a biological indicator of FIG. 4A that has been activated (for example, the fluorescently activated substrate and spores are in fluid contact);

[0033] FIG. 4C is a partial perspective view of an embodiment of the sterilization indicator reading apparatus of FIGS. 1 to 3 including a biological indicator of FIGS. 4A and 4B;

[0034] FIG. 5 is a flow diagram of the heating control of the sterilization indicator reading apparatus of FIGS. 1 to 4C;

[0035] FIG. 6 is a flow diagram of the fluorescence indication reading controller of the sterilization indicator reading apparatus of FIGS 1 to 5; and

[0036] FIG. 7 is a flow diagram of the color indicator control of the sterilization indicator reading apparatus of FIGS 1 to 6.DETAILED DESCRIPTION

[0037] The present disclosure provides a sterilization indicator reading apparatus configured to authenticate a color indicator sealed within a biological indicator. In response to affirmative authentication, the sterilization indicator reading apparatus provides a method to determine the effectiveness of a sterilization process the biological indicator was exposed to.

[0038] The present disclosure provides various embodiments of a sterilization indicator reading apparatus. In an embodiment of the present disclosure, the sterilization indicator reading apparatus includes a plurality of wells disposed in a housing configured to receive a plurality of biological indicators. A heater is thermally coupled with each well. The housing further includes a printed circuit board including a plurality of fluorescent excitation sources, white light sources, and color sensors. The printed circuit board further includes a processor and a memory. The process is communicatively coupled with the heaters, the plurality of fluorescent excitation sources, white light sources, and color sensors.

[0039] It may be desirable for a sterilization indicator reading apparatus to determine whether there is a biological indicator present in the well to provide feedback to the user (for example, whichsamples are positioned properly and currently being evaluated by the apparatus). It may be desirable for a sterilization indicator reading apparatus to determine whether a biological indicator is activated in a well during the incubation process (for example, to provide feedback to the user and eliminate wasted time due to an inactive biological indicator). It may be desirable for a sterilization indicator reading apparatus to run a preset heating profde based on the color of the color indicator sealed within the biological indicator corresponding to a type of biological indicator to eliminate user error (for example, entering the wrong heating profile or biological indicator type in the sterilization indicator reading apparatus). It may be desirable for a sterilization indicator reading apparatus to reduce time to heat the biological indicator thus reducing time to obtain results. It may be desirable for a sterilization indicator reading apparatus to determine whether the biological indicator used is an authentic article to ensure reliability of the sterilization reading.

[0040] In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus determines whether there is a biological indicator sample present in the well to provide feedback to the user whether samples are positioned properly and currently being evaluated by the apparatus.

[0041] In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus determines whether a biological indicator is activated in a particular well during the incubation process to provide feedback to the user and reduce wasted time due to an inactive biological indicator.

[0042] In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus determines and executes a preset heating profile based on the type of biological indicator (as determined by the color indicator within the biological indicator measured color value) to reduce user error of entering the wrong heating profile and / or user error of biological indicator type in the sterilization indicator reading apparatus.

[0043] In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus reduces time to heat the biological indicator thus reducing time to obtain results.

[0044] In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus determines whether the biological indicator used is an authentic article to ensure reliability of the sterilization reading.

[0045] Sterilization indicator reading apparatuses may be used to evaluate the biological indicator after the biological indicator undergoes the sterilization process to determine the effectiveness of the sterilization process (that is, whether the sterilization process was able to effectively destroy the test organism of the biological indicator). Conventional reading apparatuses may be slow to evaluate the biological indicator, thus causing a delay in obtaining a result indicativeof the effectiveness of the sterilization process. Moreover, conventional reading apparatuses may use large heater blocks that requires substantial warm up time and additional energy in heating. Furthermore, conventional reading apparatuses may require the user to input various parameter (for example, temperature, incubation time, etc.) which may introduce human error and may cause undesirable results.

[0046] As used herein, the term "sterilization" refers to a process of eliminating all bacteria and other living organisms from the surfaces of instruments, medical devices, implants, and other articles used in sterile surgical procedures. A conventional thermal sterilization process uses steam under pressure. Low-temperature chemical sterilization processes use ethylene oxide, hydrogen peroxide, hydrogen peroxide / plasma, or peracetic acid in liquid or vapor form as the sterilant, as well as gamma irradiation and electron beam sterilization.

[0047] As used herein, the term "sterilizer" refers to a system or an apparatus that can conduct a sterilization cycle, that is, a process of completely destroying all viable sources of biological activity, such as microorganisms, including structures such as viruses and spores. As used herein, the term "result" refers to an outcome indicative of an effectiveness of a sterilization cycle that can be determined by a sterilization indicator reading apparatus by reading a sterilization indicator that has undergone the sterilization cycle. The result may be positive or negative. A positive result refers to an unsuccessful sterilization of the sterilization indicator after undergoing the sterilization process. The positive result may be determined by the sterilization indicator reading apparatus upon detection of a presence of biological activity (for example, by detection of unsterilized microorganisms) in the sterilization indicator after undergoing the sterilization process. A negative result refers to a successful sterilization of the sterilization indicator after undergoing the sterilization process. The negative result may be determined by the sterilization indicator reading apparatus when the presence of biological activity is not detected in the sterilization indicator after undergoing the sterilization process. The negative result is indicative of effective sterilization. In other words, the negative result indicates that microorganisms in the sterilization indicator are effectively killed during the sterilization process.

[0048] As used herein, the term “activation” refers to breaking an embedded media capsule (i.e., ampoule) to allow for contact of the media released from the embedded media capsule with the spores.

[0049] The sterilization indicator reading apparatus may be any suitable material sufficient to provide a structure to assist with determining the effectiveness of a sterilization process in a reliable and timely manner. Further, a sterilization indicator reading apparatus may be any suitable shape or size. The sterilization indicator reading apparatus may be formed by any suitable number of topportions, side portions, and bottom potions. In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus includes a top portion, a side portion, and a bottom portion.

[0050] A sterilization indicator may include any suitable mechanical components. Examples of suitable mechanical components include wells, covers, vents, graspable portions, fdters, spacers, or any other mechanical components to assist with determining the effectiveness of a sterilization process in a reliable and timely manner. A sterilization indicator reading apparatus may further include any suitable electrical components. Examples of suitable electronic components may include sensors, display elements, circuit boards, processors, light sources, excitation sources, batteries, heaters, or any other electrical components to assist with determining the effectiveness of a sterilization process in a reliable and timely manner.

[0051] It may be desirable for the sterilization indicator reading apparatus to include a plurality of wells. In some embodiments, a sterilization indicator reading apparatus may include one well to receive a biological indicator sample. In some embodiments, a sterilization indicator reading apparatus may include a two or more wells to receive biological indicator samples. The well of a sterilization indicator reading apparatus may be any suitable shape or size to receive a biological indicator. The well may be disposed in any suitable location on the sterilization indicator reading apparatus. The plurality of wells may be arranged in any suitable configuration (for example, linear, non-linear, etc.). The well may have any suitable depth configured to receive at least a part of a biological indicator. In one or more embodiments presented herein, the well is a cylindrical shape disposed in the housing of the sterilization indicator reading apparatus and configured to receive at least a part of a biological indicator.

[0052] A well of the sterilization indicator reading apparatus may be any suitable material suitable for measuring the effectiveness of the biological indicator activity within the well. In some embodiments, the well may be a transparent material. In some embodiments, the well may be defined by the heater. In some embodiments, the well may be defined by a portion of the heater and a portion of a transparent material.

[0053] In one or more embodiments, the plurality of wells are thermally isolated from each other. In such a configuration, each well may be independently controlled. As a result, the sterilization indicator reading apparatus may simultaneously read a plurality of biological indicators. Moreover, the plurality of wells may be independently controlled such that the sterilization indicator reading apparatus may simultaneously read several types of biological indicators having different incubation requirements. Therefore, the sterilization indicator reading apparatus may effectively control the temperature of respective coupling portions of the plurality of wells to reduce the time taken to read the plurality of sterilization indicators (that may have different incubation requirements) and obtain results indicative of the effectiveness of the sterilization processes.

[0054] The well of the sterilization indicator reading apparatus may further include a well axis. In one or more embodiments of the present disclosure, the well axis is in the z-dimension and aligned vertically. The well axis is positioned at the center point of the well cavity and extends from the well opening to the well bottom.

[0055] The sterilization indicator reading apparatus may include a heater assembly disposed in the housing. In one or more embodiments presented herein, the sterilization indicator reading apparatus includes any suitable number of heaters coupled to any number of wells. The heater may be disposed in any suitable position within the housing. In some embodiments, the heater is coupled with a well. In some embodiments, the heater forms a part of the well with the housing. In some embodiments, the heater is a coil formed around the well but not in physical contact with the well.

[0056] The heater may include any suitable components. Examples of suitable heater components may include a heater element, a heater block, an insulating material, a temperature sensor, or any other suitable component to control and heat the well of a sterilization indicator reading apparatus. The heater may include any suitable number of heater components, and the heater components may be arranged in any suitable order. The heater may be any suitable size or shape depending on the desired heating properties required.

[0057] The heater may include a heater block configured to distribute heat from a heater element. A heater block may be any suitable material. Examples of suitable materials may include thermally conductive metals, thermally conductive polymers, ceramics, non-thermally conductive polymers, or any combination of two or more. The heater block may be any suitable size or shape. For example, conventional heater blocks are large and have a large thermal mass. Any suitable number of heater blocks may be included in the heater. Furthermore, the heater block may be located in any suitable location within the housing of the sterilization indicator reading apparatus.

[0058] The heater may include a heater element that is thermally coupled to the heater block. A heater element may be any suitable heating element. Examples of suitable heater elements include polyimide heaters, resistive heaters in silicone, immersion resistive heaters, Peltier devices, or any combination of two or more. The heater may include any number of heater elements suitable for measuring and maintaining a desired temperature.

[0059] The heater may further include a temperature sensor disposed on the heater block. The temperature sensor may be any suitable temperature sensor. Examples of suitable temperature sensors include negative temperature coefficient (NTC) thermistors, resistance temperature detectors (RTDs), thermocouples, and semiconductor based integrated (IC) sensors. The temperature sensor may be disposed in any suitable location on the heater block.

[0060] The heater may optionally include an insulating layer. The insulating layer may be any suitable material. Examples of insulating materials include fiberglass, foam, wool, cellulose, aerogel, or any other suitable insulator.

[0061] The present disclosure may include any other suitable heater configuration sufficient to heat the biological indicator disposed in the well of a sterilization indicator reading apparatus. In some embodiments, a suitable heater includes radiative heat, water jacket heaters, infrared heaters, microwave heaters, or any other suitable heater.

[0062] A sterilization indicator reading apparatus may include any suitable printed circuit board to determine the effectiveness of a sterilization process in a reliable and timely manner. The printed circuit board may include any suitable electronic component. Examples of suitable electrical components include sensors, memory components, processors, excitation sources, light sources, display elements, batteries, heaters, or any other electrical component to assist with determining the effectiveness of a sterilization process in a reliable and timely manner. The printed circuit board may include any suitable number of electrical components disposed at any suitable location on the printed circuit board.

[0063] In some embodiments, a sterilization indicator reading apparatus may include one or more printed circuit boards including any of the electrical components presented herein. The printed circuit boards may be positioned in any suitable location in the sterilization indicator reading apparatus housing. In one or more embodiments of the present disclosure, the printed circuit board is positioned adjacent to the well and aligned with the well axis.

[0064] When used herein, the term “adjacent to” as used in connection with the printed circuit board, sensors, light sources, excitation sources, etc. includes any suitable distance that provides the ability to measure the effectiveness of a sterilization process in the well of the sterilization indicator reading apparatus.

[0065] When used herein, the term “aligned” or “aligned with” as used in connection with various components, axes, directions of travel, etc. includes both parallel and generally parallel arrangements. For example, two axes (or other components, features, etc.) may be described as “aligned with” when the axes (or other components, features, etc.) are both perfectly parallel with each other or nearly parallel, for example, the axes (or other components, features, etc.) may form an angle with each other that is greater than 0° but 10° or less.

[0066] It may be desirable for a printed circuit board of the sterilization indicator reading apparatus to include a controller circuit. The printed circuit board may include any suitable number of controller circuits. The controller circuit may be configured to control the various processing and executing portions of the sterilization indicator reading apparatus. The controller circuit may be anysuitable electronic device. Examples of suitable electronic devices includes a programmable logic controller, a microprocessor, a personal computing device, an external computing device or any combination of two or more. The controller circuit may be configured to communicate with a plurality of electrical components.

[0067] The controller circuit may include a processor and a memory to communicate with the plurality of electrical components. The controller circuit may include any suitable number of processors and memory components. In some embodiments the processor and memory component may control the various processing and executing portions of the reading apparatus. The processor and memory may include algorithms to respond to a condition detected in the sterilization indicator reading apparatus. The detected condition by a sensor may include a color reading from a color sensor, a fluorescence reading by a color sensor, temperature reading, an infrared reading, or any other suitable response from a sensor communicatively coupled to the processor and memory. The controller circuit may optionally save the fluorescence reading, or any other reading (for example, temperature, color indicator reading, etc.) into the memory. The memory may be analyzed at a later time or a trend may be ascertained. For example, the controller circuit may determine if there are a sufficient number of fluorescence readings to develop a trend. The controller circuit may also determine the sterilization effectiveness based on analyzing the fluorescence reading. For example, if the plurality of fluorescence readings indicates an increase in fluorescence readings relative to a level of biological growth, then the faster rate of biological growth indicates that the sterilization process was not effective. If the plurality of fluorescence readings is not increasing or increasing at a slower rate, then the controller circuit may conclude that a sterilization process was effective. One or more operations may be performed by the controller circuit in response to a non-effective or an effective sterilization cycle. For example, a display may indicate that the cycle is complete and display whether the sterilization indicator indicates an effective sterilization cycle.

[0068] The sterilization indicator reading apparatus may include a sensor. The sensor may be any suitable type of sensor. Examples of suitable sensors may include color, infrared, optical, or any other suitable sensor configured to detect color. In one or more embodiments of the present disclosure, the sensor is configured to detect the fluorescence emitted in the well of the sterilization indicator reading apparatus. In one or more embodiments of the present disclosure, the sensor is configured to detect the presence of a biological indicator in the well. In one or more embodiments of the present disclosure, the sensor is configured to detect a color emitted in the well.

[0069] The sterilization indicator reading apparatus may include excitation sources to excite fluorescently excitable substances that may be present in the well. The excitation source may be any suitable excitation source that causes the substance in the well to emit fluorescence. Examples of excitation sources include electromagnetic radiation (that is, having a wavelength ranging from 10nanometers to 900 nanometers), light emitting diodes, broadband sources (for example, mercury-arc and tungsten-halogen lamps), lasers, or any combination of two or more.

[0070] The sterilization indicator reading apparatus may include any suitable number of excitation sources. The excitation source may be positioned at any suitable location on the printed circuit board or within the housing of the sterilization indicator reading apparatus.

[0071] The sterilization indicator reading apparatus may include light sources to direct light into the well. Any suitable number of light sources may be used and may be positioned in any suitable location on the circuit board or in the housing. In addition, any suitable light source may be used. Examples of suitable light sources may include lasers, light emitting diodes, broadband sources (for example, mercury-arc and tungsten-halogen lamps), or any other suitable light source.

[0072] In one or more embodiments of the present disclosure, the light source used in the sterilization indicator reading apparatus may be a white light source. Any suitable white light source may be used. Examples of suitable white light sources may include lasers, light emitting diodes, broadband sources (for example, mercury-arc and tungsten-halogen lamps), or any other suitable light source that ranges from 380 nanometers to 900 nanometers.

[0073] The sterilization indicator reading apparatus may include a color sensor configured to detect a color wavelength in the well. Any suitable color sensor may be used. Examples of suitable detectors include variable wavelength detectors, diode array detectors, multiple wavelength detectors, photomultiplier tubes, silicone diodes, or any other suitable detectors configured to detect a wavelength.

[0074] Biological indicators may be used for a plurality different sterilization processes. Biological indicators may be placed in a test package within a load containing articles to be sterilized. After, the biological indicator may be evaluated in a sterilization indicator reading apparatus to determine the effectiveness of the sterilization process.

[0075] A biological indicator may include a transparent container. Any suitable transparent container may be used to contain the components of the biological indicator in order to read and measure the effectiveness of a sterilization process. Examples of suitable transparent containers may include a tube, a plastic pouch, self-contained ampules, or any other suitable transparent container.

[0076] The biological indicator transparent container may be any suitable material. Examples of suitable transparent materials include glass, plastic, ceramic, or any other transparent material. The transparent container may be any suitable shape or size suitable for containing the components of the biological indicator. The biological indicator transparent container further includes a cap used to contain the components of the biological indicator.

[0077] As used herein, the phrase “transparent” means that the substrate transmits greater than 50% of light incident on the substrate for a selected wavelength or range of wavelengths, assuming no reflection at the air-substrate boundaries.

[0078] The biological indicator may include a biological agent. The biological agent carried by the biological indicator is typically a test organism which is far more resistant to the sterilization process than most organisms that are present due to natural contamination. The biological agent may include any suitable test organism. Examples of suitable organisms include enzymes, endospores, bacterial spores, or any other suitable organism.

[0079] The biological indicator may have any suitable internal volume. In one or more embodiments of the present disclosure, the internal volume of the biological indicator may be 0.8 milliliters (mL) or less, 0.7 m or less, 0.6 m or less, 0.5 mL or less, 0.4 mL or less, 0.3 mL or less, or 0.2 mL or less. In one or more embodiments of the present disclosure, the internal volume of the biological indicator may be 0. 1 mL or greater, 0.2 mL or greater, 0.3 mL or greater, 0.4 mL or greater, 0.5 mL or greater, 0.6 mL or greater, or 0.7 mL or greater. In one or more embodiments of the present disclosure, the internal volume of the biological indicator may be 0. 1 mL to 0.8 mL, 0.3 mL to 0.7 mL, 0.4 mL to 0.6 mL, 0.55 mL to 0.65 mL. In a preferred embodiment, the internal volume of the biological indicator may be 0.6 mL.

[0080] Enzymes may be used in biological indicators. Any suitable enzyme may be used for a specific sterilization process. Examples of suitable enzymes may include alpha-glucosidase enzyme system, which is generated naturally within growing cells of Geobacillus stearothermophilus . The alpha-glucosidase in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a substance (for example, a non-fluore scent substrate, 4-methyl-umbellifery 1-alpha-D-glucoside (MUG)).

[0081] Spores used in the biological indicator may be any suitable spore for a specific sterilization process. Examples of spores used in a steam sterilization process may include Geobacillus stearothermophilus, bacillus stearothermophilus, or any other suitable spore. Examples of spores used in an ethylene oxide sterilization process may include bacillus atrophaeus. In some embodiments, the sterilization process resistant spores may include one or more of Geobacillus stearothermophilus, Bacillus stearothermophilus, Bacillus subtilis, Bacillus atrophaeus, Bacillus megaterium, Bacillus coagulans, Clostridium sporogenes, and bacillus pumilus.

[0082] Enzymes and substrates that may be suitable for use in the biological sterilization indicator of the present disclosure are identified in U.S. Pat. No. 5,073,488 (Matner et al), U.S. Pat. No. 5,418,167 (Matner et al.), and U.S. Pat. No. 5,223,401 (Foltz et al.), which are incorporated herein by reference.

[0083] The biological indicator may further include a fluorescently responsive substrate. A fluorescently responsive substrate includes any substrate that emits a wavelength ranging from 10 nanometers to 900 nanometers. Any suitable fluorescently responsive substrate may be used. Examples of fluorescently responsive substrates may include 4-methylumbelliferyl-alpha-D- glucopyranoside (4-MUG), 4-methylumbelliferyl-alpha-D-maltopyranoside (4-MUM), 6,8-difluoro-4- methylumbelliferyl-alpha-D-glucopyranoside (DFMUG), 6-phospho-4-methylumbelliferyl-alpha-D- glucopyranoside (6-PMU), 2-naphthyl alpha-D-glucopyranoside (2-NAG), fluorescein-alpha-D- glucopyranoside (Fluorescein-Glc), 7-hydroxy-4-methylcoumarin-alpha-D-glucopyranoside (HMCG), cresyl violet alpha-D-glucopyranoside, or any combination of two or more.

[0084] The 4-methylumbelliferyl-alpha-D-glucopyranoside (4-MUG) substrate is a widely used substrate for alpha-glucosidase assays with an excitation wavelength of about 360 nm and an emission wavelength of about 450 nm. The 4-methylumbelliferyl-alpha-D-maltopyranoside (4-MUM) substrate is a derivative of 4-methylumbelliferone (4-MU) with an excitation wavelength of about 360 nm and an emission wavelength of about 450 nm. The 6,8-difluoro-4-methylumbelliferyl-alpha-D- glucopyranoside (DFMUG) substrate is a modified version of 4-MUG with enhanced fluorescence properties with an excitation wavelength of about 355 nm and an emission wavelength of about 450 nm, The 6-phospho-4-methylumbelliferyl-alpha-D-glucopyranoside (6-PMU) substrate is a phosphorylated variant of 4-MUG, suitable for studying alpha-glucosidase with specific recognition for phosphorylated sugars with an excitation wavelength of about 360 nm and an emission wavelength of about 450 nm. The 2-naphthyl alpha-D-glucopyranoside (2-NAG) substrate is a substrate that produces a fluorescent naphthalene derivative upon hydrolysis by alpha-glucosidase with an excitation wavelength of about 290 nm and an emission wavelength of about 340 nm. The fluorescein-alpha-D-glucopyranoside (Fluorescein-Glc) substrate is a fluorescein-based substrate, which produces a fluorescent signal when cleaved with an excitation wavelength of about 495 nm and an emission wavelength of about 520 nm. The 7-hydroxy-4-methylcoumarin-alpha-D- glucopyranoside (HMCG) substrate is a coumarin derivative that fluoresces after enzyme cleavage with an excitation wavelength of about 380 nm and an emission wavelength of about 450 nm. The cresyl violet alpha-D-glucopyranoside substrate is a substrate that releases cresyl violet upon hydrolysis with an excitation wavelength of about 590 nm and an emission wavelength of about 680 nm.

[0085] The fluorescently responsive substrate may be present in the biological indicator at any suitable volume. Examples of suitable volumes may include 0.8 milliliters (mL) or less, 0.7 mL or less, 0.6 mL or less, 0.5 mL or less, 0.4 mL or less, 0.3 mL or less, or 0.2 mL or less. In one or more embodiments of the present disclosure, the volume of the fluorescently responsive substrate may be 0.1 mL or greater, 0.2 mL or greater, 0.3 mL or greater, 0.4 mL or greater, 0.5 mL or greater, 0.6 mL or greater, or 0.7 mL or greater. In one or more embodiments of the present disclosure, the volume ofthe fluorescently responsive substrate may be 0. 1 mb to 0.8 mb, 0.3 mb to 0.7 mb, 0.4 mb to 0.6 mb, 0.55 mb to 0.65 mb.

[0086] The fluorescently responsive substrate may be contained in an ampoule. The ampoule is disposed within the biological indicator. The ampoule may be any suitable transparent material, for example. Examples of suitable transparent materials include glass, plastic, ceramic, foil pouch, or any combination of two or more. The transparent ampoule may be any suitable shape or size suitable for containing the fluorescently responsive substrate.

[0087] A biological indicator may further include a breaker element. A breaker element at least partially surrounds the ampoule in the biological indicator and assists with fracturing the ampoule to release the fluorescently responsive substrate into the biological indicator area containing the spores or enzymes. Any suitable puncturing method may be used to fracture the ampoule, for example, fracturing, piercing, crushing, cracking, or breaking.

[0088] In one or more embodiments of the present disclosure, the breaker element is or includes a color indicator. The color indicator may exhibit any suitable wavelength from 380 nanometers to 750 nanometers. The breaker element may be any suitable material. Examples of suitable materials includes plastics, metals, ceramics, or any combination of two or more.

[0089] The breaker element may be disposed in any suitable location in the biological indicator so that it may be detected by the sterilization indicator reading apparatus. In one or more embodiments of the present disclosure, the breaker element partially surrounds the ampule in the portion of the biological indicator that aligns with to the second region of the well of the sterilization indicator reading apparatus.

[0090] The breaker element may be any suitable size to effectively puncture the ampoule containing the fluorescently responsive substrate and be detected by the color sensors in the sterilization indicator reading apparatus.

[0091] FIG. l is a perspective view of one embodiment of a sterilization indicator reading apparatus 10 including a housing 100. The housing 100 includes atop portion 110, a bottom portion 120 opposite the top portion 110, and a side portion 130 that extends between the top portion 110 and the bottom portion 120.

[0092] The top portion 110 may be any suitable size or shape. The top portion 110 may be defined by any suitable number of surfaces. The top portion 110 may by any suitable material with an opacity of at least 99 percent as measured by ASTM D6216. Examples of suitable material may include metals, plastics, ceramics, glass, or any combination of two or more. The top portion 110 may include any suitable number of wells 150 disposed in the housing 100. In one or more embodimentsof the present disclosure the well 150 may include a well opening 152 defined by the surface 112 of the top portion. The well opening 152 may be any suitable size to receive a biological indicator 200. In some embodiments, the top portion 110 may include display elements 300 configured to communicate information to the user. Any suitable display components may be used to form the display elements 300.

[0093] The bottom portion 120 may be any suitable size or shape. The bottom portion 120 may be defined by any suitable number of surfaces. The bottom portion 120 may be any suitable material with an opacity of at least 99 percent as measured by ASTM D6216. Examples of suitable material may include metals, plastics, ceramics, glass, or any combination of two or more. The bottom portion 120 may include any suitable number of wells 150 disposed in the housing 100. In one or more embodiments of the present disclosure the well 150 may include a well opening 152 defined by the bottom portion of the surface. The well opening 152 may be any suitable size to receive a biological indicator 200. In some embodiments, the bottom portion 120 may include display elements 300 configured to communicate information to the user. Any suitable display components may be used to form the display elements 300.

[0094] The side portion 130 may be any suitable size or shape. The side portion 130 may be defined by any suitable number of surfaces. In one or more embodiments of the present disclosure, the side portion 130 is defined by a side portion surface 132 extending from the top portion 110 to the bottom portion 120 and forming the housing 100. In some embodiments, the side portion 130 may include two or more surfaces that extend from the top portion 110 to the bottom portion 120 and form the housing 100. The side portion 130 may be any suitable material with an opacity of at least 99 percent as measured by ASTM D6216. Examples of suitable material may include metals, plastics, ceramics, glass, or any combination of two or more. The side portion 130 may include any suitable number of wells 150 disposed in the housing 100. In one or more embodiments of the present disclosure the well 150 may include a well opening 152 defined by the side portion surface 132. In some embodiments, the side portion 130 may include display elements 300 configured to communicate information to the user. Any suitable display components may be used to form the display elements 300.

[0095] The top portion 110, the bottom portion 120, and the side portion 130 of the housing may be connected using any suitable technique. Examples of suitable techniques include welding, adhesively coupling, mechanically fastening, friction fitting, or a combination of two or more.

[0096] The housing 100 of the sterilization indicator reading apparatus 10 includes a well 150 and a well opening 152. In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus 10 may include any suitable number of wells 150 depending on the requirements of the consumer and the limitations of the size of the housing 100. In someembodiments, the sterilization indicator reading apparatus 10 may include a plurality of wells disposed in any suitable location on the housing 100. The plurality of wells may be aligned linearly, non-linearly, or randomly.

[0097] In one or more embodiments of the present disclosure, the well 150 may include a depth suitable for a desired biological indicator to be at least partially disposed within the housing 100. In some embodiments, the well 150 may include a depth that is the same length as the biological indicator 200. The diameter of the well 150 may include any suitable shape or side to match a desired biological indicator. Examples of suitable shapes may include rectangular, elliptical, circular, or any other shape configured to match a desired biological indicator. In one or more preferred embodiments of the present disclosure, the well 150 may be a circular shape configured to match the size of a desired biological indicator 200.

[0098] The well opening 152 of the well 150 may be any suitable shape or size to match a desired biological indicator 200. Examples of suitable shapes may include rectangular, elliptical, circular, or any other shape configured to match a desired biological indicator. In one or more preferred embodiments of the present disclosure, the well opening 152 may be a circular shape configured to match the size and shape of a biological indicator 200.

[0099] In FIGS. 2A-2B the well 150 of the sterilization indicator reading apparatus 10 further includes a well axis 154 which extends from the well opening 152 defined by the top portion surface 112 to the well bottom end 156 disposed within the housing 100. The well axis 154 is at the center point of the well 150. In some embodiments, the well axis 154 is equidistant from each of the surfaces that define the well. The well includes a first region 160 and a second region 170 that are spaced apart from each other a lateral distance along the well axis 154. The first region 160 is proximate the well bottom end 156. The second region 170 is proximate the well top end 158. In one or more embodiments of the present disclosure, the well axis 154 extends from the well opening 152 defined by the top portion surface 112 through the second region 170 and then through the first region 160 to the well bottom end 156. The first region 160 and a second region 170 may be optically isolated from each other.

[0100] As used herein, the term “optically isolated” used in connection with various regions of a well of a sterilization indicator reading apparatus, refers to illumination and detection of optical signals in one region occurs without transmission or interference of light to or from neighboring regions. Optical isolation may be achieved by light-blocking barriers, separate optical housings, or individual detection channels, for example.

[0101] The sterilization indicator reading apparatus 10 further includes a heater 180 disposed adjacent to the well 150 within a well spacer 159. The heater 180 may include a heater element (not shown) that is thermally coupled to the heater block (not shown).

[0102] A printed circuit board 500 is disposed within the housing 100 of the sterilization indicator reading apparatus 10. In some embodiments, the printed circuit board 500 is completely disposed within the housing 100. In some embodiments, the printed circuit board is disposed partially within the housing 100. The printed circuit board 500 may include any suitable number of printed circuit boards configured to determine the effectiveness of a sterilization process. In some embodiments, the sterilization indicator reading apparatus 10 may include two or more printed circuit boards. The printed circuit board 500 may be positioned in any suitable location in the housing 100 of the sterilization indicator reading apparatus 10. In one or more embodiments of the present disclosure, the printed circuit board 500 is positioned adjacent to the well 150 and aligned with the well axis 154.

[0103] In FIG. 3, a schematic view of an illustrative sterilization indicator reading apparatus 10 is illustrated. The sterilization indicator reading apparatus 10 includes a printed circuit board 500 aligned with the well 150 and the well axis 154. The well axis 154 extends from the well opening 152 through the second region 170 and then through the first region 160 to the well bottom end 156.

[0104] The printed circuit board 500 includes a first fluorescence excitation source 510, an optional second fluorescence excitation source 512, and a first light source 520 configured to direct light into the first region 160 of the well. A first color sensor 530 sensor is configured to measure the fluorescence in the first region 160 of the well 150 and detect the color in the first region 160 of the well. The printed circuit board 500 further includes a second light source 522 configured to direct light into the second region 170 of the well 150. A second color sensor 532 optically communicates with the second region 170 of the well 150.

[0105] As used herein, the term “optical communication” or derivatives thereof refers to a condition or configuration in which light, optical energy, or an optical signal may be transmitted, received, or otherwise exchanged between two or more components. Components that are said to “optically communicate” may do so directly or indirectly, such as through one or more intervening optical elements (for example, lenses, filters, fibers, or transparent media). The printed circuit board may include any suitable number of fluorescent excitation sources, light sources, and color sensors to provide an effective reading of a biological indicator 200.

[0106] An excitation source may be any suitable excitation source that causes the substance in the well 150. Examples of excitation sources include electromagnetic radiation (that is, having a wavelength ranging from 10 nanometers to 400 nanometers), light emitting diodes, broadband sources (for example, mercury-arc and tungsten-halogen lamps), lasers, or any combination of two or more.

[0107] A light source may be any suitable light source configured to direct light into the well 150. Any suitable light source may be used. Examples of suitable light sources may include lasers, light emitting diodes, broadband sources (for example, mercury-arc and tungsten-halogen lamps), or any other suitable light source.

[0108] In one or more embodiments of the present disclosure, the light source used in the sterilization indicator reading apparatus may be a white light source. Any suitable white light source may be used. Examples of suitable white light sources may include lasers, light emitting diodes, broadband sources (for example, mercury-arc and tungsten-halogen lamps), or any other suitable light source that ranges from 380 nanometers to 750 nanometers.

[0109] In one or more embodiments of present disclosure, the sterilization indicator reading apparatus 10 includes a first color sensor 530 that includes an infrared detector. This feature provides the desired result of detecting whether an article is present in the first region 160 in the well 150.

[0110] In one or more embodiments of present disclosure, the sterilization indicator reading apparatus 10 includes a second color sensor 532 that includes an infrared detector. This feature provides the desired result of detecting whether an article is present in the second region 170 in the well 150.

[0111] In one or more embodiments of present disclosure, the sterilization indicator reading apparatus 10 includes a first color sensor 530 that measures wavelength. This feature provides the desired result of determining whether a biological indicator is activated.

[0112] In one or more embodiments of present disclosure, the sterilization indicator reading apparatus 10 includes a second color sensor 532 that measures wavelength. This feature provides the desired result of reading the color of a biological indicator in the second region 170 in the well 150 to determine a preset heating profile.

[0113] A controller circuit (not shown) is disposed on the printed circuit board 500. The printed circuit board 500 may include any suitable number of controller circuits. The controller circuit may be configured to control the various processing and executing portions of the sterilization indicator reading apparatus 10.

[0114] The controller circuit may include a processor (not shown) and a memory (not shown) to communicate with the electrical components of the sterilization indicator reading apparatus 10. In one or more embodiments of the present disclosure, the processor (not shown) on the printed circuit board 500 is communicatively couples to the heater 180, the first fluorescence excitation source 510, the second fluorescence excitation source 512, the first light source 520, the first color sensor 530, the second light source 522, and the second color sensor 532.

[0115] The printed circuit board 500 (that is, the processor and memory) may include algorithms or programs to respond to a condition detected in the well 150 of the sterilization indicator reading apparatus 10. The detected condition by a sensor may include a color reading from a color sensor, a fluorescence reading by a color sensor, temperature reading, an infrared reading, or any other suitable response from a sensor communicatively coupled to the processor and memory.

[0116] In one or more embodiments of the present disclosure, the memory includes a plurality of preset heating profdes. The heating profdes are discussed in further detail herein.

[0117] FIGS. 4A-4C are a side view of one embodiment of the biological indicator 200. The biological indicator 200 includes a transparent tube 210 and a cap 212 which contains the biological indicator components.

[0118] A biological indicator may include a transparent tube 210. Any suitable transparent tube may be used to contain the components of the biological indicator in order to read and measure the effectiveness of a sterilization process. Examples of suitable transparent tubes may include a tube, a plastic pouch, self-contained ampules, or any other suitable transparent container. The biological indicator transparent tube 210 may be any suitable material. Examples of suitable transparent materials include glass, plastic, ceramic, or any other transparent material. The transparent container may be any suitable shape or size suitable for containing the components of the biological indicator. As illustrated, the cap 212 typically includes a white label substantially covering the surface of the cap 212.

[0119] As used herein, the phrase “transparent” means that the substrate transmits greater than 50% of light incident on the substrate for a selected wavelength or range of wavelengths, assuming no reflection at the air-substrate boundaries.

[0120] The transparent tube 210 may have any suitable internal volume. In one or more embodiments of the present disclosure, the internal volume of the transparent tube 210 may be 0.8 milliliters (mL) or less, 0.7 mb or less, 0.6 mb or less, 0.5 mb or less, 0.4 mb or less, 0.3 mb or less, or 0.2 mL or less. In one or more embodiments of the present disclosure, the internal volume of the transparent tube 210 may be 0. 1 mL or greater, 0.2 mL or greater, 0.3 mL or greater, 0.4 mL or greater, 0.5 mL or greater, 0.6 mL or greater, or 0.7 mL or greater. In one or more embodiments of the present disclosure, the internal volume of the transparent tube 210 may be 0. 1 mL to 0.8 mL, 0.3 mL to 0.7 mL, 0.4 mL to 0.6 mL, 0.55 mL to 0.65 mL. In a preferred embodiment, the internal volume of the transparent tube 210 may be 0.6 mL.

[0121] Disposed or sealed within the biological indicator 200 is an ampoule 230 at least partially surrounded by a breaker element 220. In some embodiments, the breaker element 220 completely surrounds the ampoule 230. The breaker element 220 includes a color indicator. This feature providesthe desired result of communicating the biological indicator type to the sterilization indicator reading apparatus 10 via the second color sensor 532.

[0122] In one embodiment, the color indicator of the breaker element 220 is located entirely within the biological indicator.

[0123] In one embodiment, the color indicator of the breaker element 220 is located entirely within the well 150 of the housing 100 of the sterilization indicator reading apparatus 10.

[0124] In one embodiment, the printed circuit board 500 including the first fluorescence excitation source 510, the second fluorescence excitation source 512, the first color sensor 530, the second color sensor 532, the first light source 520, and the second light source 522 are all located entirely within the housing 100 of the sterilization indicator reading apparatus 10.

[0125] The color indicator of the breaker element 220 may emit or reflect any suitable wavelength between 380 nanometers (nm) and 750 nm. In some embodiments, the wavelength emitted (reflected) from the color indicator of the breaker element 220 is 750 nm or less, 700 nm or less, 650 nm or less, 600 nm or less, 550 nm or less, 500 nm or less, 450 nm or less, 400 nm or less, or 380 nm or less. In some embodiments, the wavelength emitted (reflected) from the color indicator of the breaker element 220 is 375 nm or greater, 400 nm or greater, 450 nm or greater, 500 nm or greater, 550 nm or greater, 600 nm or greater, 650 nm or greater, or 700 nm or greater. In some embodiments, the wavelength emitted (reflected) from the color indicator of the breaker element 220 is 380 nm to 750 nm, 400 nm to 750 nm, 500 nm to 650 nm, or 550 nm to 650 nm. In one or more preferred embodiments of the present disclosure, the wavelength emitted (reflected) from the color indicator of the breaker element 220 is 380 nm to 500 nm, indicating blue color. In one or more preferred embodiments of the present disclosure, the wavelength emitted (reflected) from the color indicator of the breaker element 220 is 575 nm to 625 nm, indicating a brown color. In one or more preferred embodiments of the present disclosure, the wavelength emitted (reflected) from the color indicator of the breaker element 220 is 380 nm to 435, indicating a violet or pink color.

[0126] The ampoule 230 contains a fluorescently responsive substrate 232. Further disposed within the biological indicator 200 is a plurality of spores 250. In FIG. 4A the fluorescently responsive substrate 232 is isolated away from the spores 250. In FIG. 4B the fluorescently responsive substrate 232 is in fluid communication with the spores 250. To release the fluorescently responsive substrate 232 from the ampoule 230 the breaker element 220 punctures the ampoule 230 to allow the fluorescently responsive substrate 232 to flow into fluid communication with the spores 250. The ampoule may contain any suitable volume of a fluorescently responsive substrate 232 sufficient to react with the spores 250.

[0127] The fluorescently responsive substrate 232 in fluid contact with the spores 250 within the biological indicator 200 emit a wavelength. In one or more embodiment of the present disclosure, the wavelength of the fluorescently responsive substrate 232 in fluid contact with the spores 250 may be measured and detected by the first color sensor 530. In one or more embodiment of the present disclosure, the wavelength of the fluorescently responsive substrate 232 in fluid contact with the spores 250 may be any suitable wavelength between 380 nanometers (nm) to 750 nm. In one or more embodiment of the present disclosure, the wavelength of the fluorescently responsive substrate 232 in fluid contact with the spores 250 may be 750 nm or less, 700 nm or less, 650 nm or less, 600 nm or less, 550 nm or less, 500 nm or less, 450 nm or less, 400 nm or less, or 380 nm or less. In one or more embodiment of the present disclosure, the wavelength of the fluorescently responsive substrate 232 in fluid contact with the spores 250 may be 375 nm or greater, 400 nm or greater, 450 nm or greater, 500 nm or greater, 550 nm or greater, 600 nm or greater, 650 nm or greater, or 700 nm or greater. In one or more embodiment of the present disclosure, the wavelength of the fluorescently responsive substrate 232 in fluid contact with the spores 250 may be 380 nm to 750 nm, 400 nm to 750 nm, 500 nm to 650 nm, or 550 nm to 650 nm. In one or more preferred embodiments of the present disclosure, the wavelength emitted from the color indicator of the breaker element 220 is 380 nm to 450 nm, a purple color.

[0128] FIG. 4C is a perspective view of one embodiment of the sterilization indicator reading system 10 with a biological indicator 200 (with the side housing removed). The biological indicator 200 is disposed in the well 150 of the sterilization reading apparatus 10. The printed circuit board 500 includes the first excitation source 510, the second optional excitation source 512, first light source 520, first color sensor 530, second light source 522, and second color sensor 532. The color indicator of the breaker element 220 are in optical communication with the second color sensor 532 and the second light source 522 in the second region 170 of the well 150. The fluorescently responsive substrate 232 and spores 250 are in optical communication with the first excitation source 510, the second excitation source 512, first light source 520, and first color sensor 530 in the first region 160 of the well 150.

[0129] FIG. 5 is a flow diagram of the heating control of the sterilization indicator reading apparatus of FIGS. 1-4C. The method 600 begins with block 610. In block 610, the heater control heats the heater 180 to a preset temperature, that is, activate the heater element and heat from a first temperature to a second, preset temperature. The heat from the heating element is distributed over the heater block to provide even temperature of the biological indicator 200. In some embodiments, a temperature sensor senses the temperature of the heater block, heating element, medium, or combinations thereof.

[0130] The preset temperature may be different for each well depending on the type of biological indicator 200 or user preferences. For example, a first well may be heated to 60 degrees Celsius and the second well may be heated to 54 degrees Celsius. In one or more embodiments of the present disclosure, block 610 may also occur in response to the biological indicator being present and activated. In one or more embodiments of the present disclosure, the block 610 may also occur in response to a condition in the well. This feature provides the desired result of each well being controlled to a desired heating profile based on the biological indicator type.

[0131] In one or more embodiments of the present disclosure, activating the fluorescence detection cycle described in block 650 occurs in response to the second (preset) temperature being achieved. In block 620, the heater control determines whether the preset temperature is achieved. The preset temperature may be dependent on the biological indicator type. If the preset temperature is reached, then the method 600 may continue to block 650.

[0132] In block 630, the controller circuit of the circuit board 500 determines activation status. In one or more embodiments of the present disclosure, the activation detection circuit detects the presence of a wavelength of the biological indicator 200. In addition, the wavelength allows the heater control to determine the preset temperature. In one or more embodiments of the present disclosure, the activation status may be determined continuously over the entire period of a fluorescence detection cycle (block 650) to verify that there is an activated biological indicator 200 present in the well 150. If, after the biological indicator 200 is activated, the biological indicator 200 is later removed from the well 150 during a fluorescence detection cycle, then an error is triggered, and the fluorescence detection cycle is stopped. Alternatively, if the biological indicator 200 is later removed during a fluorescence detection cycle after being activated, then an automatic failure indication may be triggered to reset the cycle.

[0133] In block 640, if the biological indicator is activated, then the method 600 continues to block 650. In one or more embodiments of the present disclosure, the method 600 may continue to block 645 in response to either block 640 or 620, or both being affirmative. In one or more embodiments of the present disclosure, the status may be a color change of the display to indicate that the well 150 is ready to receive the biological indicator 200. This may happen before or after a biological indicator 200 is inserted into the well and the activation status of the biological indicator is determined in block 660.

[0134] In block 647, the controller circuit of the circuit board 500 may, via the display microcontroller, cause the display to display a timer sequence. The timer sequence may indicate the amount of time for the sterilization indicator reading apparatus 10 to yield a positive or negative result of the biological indicator 200. For example, the timer sequence may be activated based on an indication that the biological indicator 200 has been activated in block 640. Once activated, thecontroller circuit starts a predetermined timer sequence that approximates the time until a sterilization efficacy determination is achieved. In one or more embodiments of the present disclosure, removal of the biological indicator 200 from the well 150 may result in a pause of the timer sequence, whereby reinsertion of the biological indicator 200 resumes the timer sequence. In one or more embodiments of the present disclosure, the removal of the biological indicator 200 from the well 150 results in an error indication.

[0135] In block 650, the controller circuit of the circuit board 500 may activate a fluorescence detection cycle to determine the sterilization efficacy of the sterilizer based on the biological indicator 200. For example, the controller circuit of the circuit board may activate the fluorescence detection cycle where the excitation source is activated, and fluorescence received by the color sensor. In one or more embodiments of the present disclosure, block 650 may occur based on both the biological indicator being activated and the preset temperature being reached. In one or more embodiments of the present disclosure, the incubation cycle and the fluorescence detection cycle are not mutually exclusive, thus the fluorescence detection cycle may occur at least partially concurrently with the incubation cycle. The timer sequence may be based off of the incubation cycle, fluorescence detection cycle, or combinations thereof. Once block 650 has connected, the display microcontroller may concurrently display a time remaining of the fluorescence detection cycle so that the user is alerted. In one or more embodiments of the present disclosure, the time remaining may be the output of the timer sequence where increments of time (for example, hours, minutes, seconds) are decreased to zero.

[0136] In one or more embodiments of the present disclosure, the timer sequence of block 647 may also be determined based on a prediction of the fluorescence detection cycle. For example, if the fluorescence indicates poor growth of the spores, then the controller circuit of the circuit board 500 may shorten the timer sequence based on the prediction. The prediction may be based on feedback of low fluorescence from the biological indicator. In block 660, after the sterilization efficacy is determined, the controller circuit via the display microcontroller may further display the sterilization efficacy.

[0137] FIG. 6 is a flow diagram of the fluorescence indication reading controller of the sterilization indicator reading apparatus 10 of FIGS 1-5. In one or more embodiments, the method 750 involves determining sterilization efficacy a variety of methods, such as area under the curve, root-mean-squared, thresholding, or any other suitable method.

[0138] In block 751, the excitation driver circuit may activate the first fluorescent excitation source 510 for a second time period. In some embodiments, the second time period for activating the first fluorescent excitation source 510 does not overlap with the first time period for activated the first light source 520. In addition, the first time period may have a first duration that is less than a second duration of the second time period such that the first light source 520 is not activated for as long as thefirst fluorescent excitation source 510. For example, the first time period may have a first duration of no greater than 1 second, and the second time period may have a second duration of greater than 1 second. In other embodiments, the second time period may overlap with the first time period such that both the first fluorescent excitation source 510 and the first light source 520 are activated at the same time.

[0139] In block 752, the controller circuit may receive a second reading from the first color sensor 530 corresponding to a wavelength. In block 753, the controller circuit determines a fluorescence reading from the second reading from the first color sensor 530. In block 757, the controller circuit of the circuit board may optionally deactivate the excitation source after determining the fluorescence reading in 753. In some embodiments, the circuit board may continue to operate the fluorescence excitation source.

[0140] In block 754, the controller circuit of the circuit board 500 may optionally save the florescence reading into memory. The fluorescence reading in the memory may be optionally analyzed at a later time or a trend may be ascertained. For example, in block 755, the controller circuit may determine if there are a sufficient number of fluorescence readings to ascertain a trend.

[0141] In block 755, the controller circuit of the circuit board 500 may deactivate the first fluorescent excitation source 510 based on the fluorescence reading being determinable. Determinable may mean the fluorescence is able to be determined from the first color sensor 530. If the first color sensor 530 provides a wavelength not corresponding to an appropriate spectrum, then the fluorescence is not determinable.

[0142] In block 756, the controller circuit of the circuit board 500 may determine the sterilization effectiveness based on analyzing the plurality of fluorescence readings stored in the memory. For example, if the plurality of fluorescence readings indicates an increasing fluorescence reading relative to a level of enzymatic activity, then the higher enzymatic activity indicates that the sterilization process was not effective. If the plurality of fluorescence reading is not increasing or increasing at a slower rate, then the controller circuit may conclude that a sterilization process was effective. One or more operations may be performed by the controller circuit in response to a non-effective or an effective sterilization cycle. For example, a display may indicate that the cycle is complete and display whether the sterilization indicator indicates an effective sterilization cycle.

[0143] FIG. 7 is a flow diagram of the color indicator control of the sterilization indicator reading apparatus of FIGS 1-6. In block 800, the controller circuit of the circuit board 500 activates the second color sensor 532 to detect the presence of a biological indicator 200 in the second region 170 of the well 150. In block 810, the controller circuit receives a reading from the second colorsensor 532 and subsequently deactivates the second color sensor. In block 812, if a biological indicator is not present, the controller circuit stops for 0.1 seconds and repeats block 800.

[0144] In block 820, when a biological indicator is present, the controller circuit activates a second light source 522 and the second color sensor 532 in the second region 170 of the well 150.

[0145] In block 830, when the second color sensor 532 detects the wavelength emitting from the well the controller circuit determines whether it corresponds to a wavelength stored in memory. In some embodiments, the controller circuit determines the wavelength in less than one second.

[0146] In block 840, when the wavelength from block 830 does not match a wavelength stored in memory the controller circuit shuts the sterilization indicator reading apparatus off and displays an error 842.

[0147] In block 850, when the wavelength from block 830 matches a first wavelength or first wavelength range stored in memory the controller circuit between 380 nm to 435 nm the controller circuit activates the preset algorithm corresponding to the color indicator wavelength of the breaker element 220. The controller circuit activates the first light source 520 and the first color sensor 530 to measure the color of the spores 250 and fluorescently responsive substrate 232 in the biological indicator 200. If the wavelength measured by the first color sensor 530 matches the preset wavelength stored in memory, then the biological indicator 200 is properly activated and a preset heating profile may begin. If the wavelength measured by the first color sensor 530 does not match the preset wavelength stored in memory, then the controller circuit does not activate a heating profile.

[0148] The preset heating profile may be suitable heating profile for a desired biological indicator. In block 850, the first preset heating profile is for vaporized H2O2 sterilization processes. The heating profile follows the method described in FIG. 5 where the duration of time heating is approximately five minutes long. After five minutes, the controller circuit activates the first fluorescence excitation source 510 and the second fluorescence excitation source 512 to measure the fluorescence of the biological indicator by the first color sensor 530. If the incubation is incomplete, the controller circuit shuts the first fluorescence excitation source 510, the second fluorescence excitation source 512, and first color sensor 530 off for 10 seconds before activating the first fluorescence excitation source 510 and the second fluorescence excitation source 512 again. When the fluorescence reaches a desired level stored in memory for the desired sterilization process (that is, vaporized H2O2) the circuit board 500 analyzes the data and displays a result to a user on the housing 100 or the sterilization indicator reading apparatus 10.

[0149] In another embodiment of block 850, the heating profile follows the method described in FIG. 5 where the duration of time heating is approximately five minutes long. After five minutes, the controller circuit activates the first fluorescence excitation source 510 to measure the fluorescence ofthe biological indicator by the first color sensor 530. The value measured by the first color sensor 530 is stored in memory. Subsequently, the first fluorescence excitation source and color sensor are deactivated. Next, the controller circuit activates the second fluorescence excitation source 512 to measure the fluorescence of the biological indicator by the first color sensor 530. The two fluorescence measurements would be summed and then added to memory. The difference between the two cases is simultaneous activated of the fluorescence excitation sources with one fluorescence measurement or sequential activated fluorescence excitation sources and fluorescence measurements. If the incubation is incomplete, the controller circuit shuts the fluorescence excitation sources and first color sensor 530 off for 10 seconds before repeating the same cycle. When the fluorescence reaches a desired level stored in memory for the desired sterilization process (that is, vaporized H2O2) the circuit board 500 analyzes the data and displays a result to a user on the housing 100 or the sterilization indicator reading apparatus 10.

[0150] In block 880, when the wavelength from block 830 matches a second wavelength or second wavelength range stored in memory the controller circuit between 380 nm to 500 nm or 575 nm to 625 nm the controller circuit activates the preset algorithm corresponding to the wavelength of the color indicator of the breaker element 220. The controller circuit activates the first light source 520 and the first color sensor 530 to measure the color of the spores 250 and fluorescently responsive substrate 232 in the biological indicator 200. If the wavelength measured by the first color sensor 530 matches the preset wavelength stored in memory, then the biological indicator 200 is properly activated and a preset heating profile may begin. If the wavelength measured by the first color sensor 530 does not match the preset wavelength stored in memory, then the controller circuit does not activate a heating profile.

[0151] The preset heating profile may be suitable heating profile for a desired biological indicator. In block 850, the second preset heating profile is for steam sterilization processes. The heating profile follows the method described in FIG. 5 where the duration of time heating is approximately five minutes long. After five minutes, the controller circuit activates the first fluorescence excitation source 510 to measure the fluorescence of the biological indicator by the first color sensor 530. If the incubation is incomplete, the controller circuit shuts the first fluorescence excitation source 510 and first color sensor 530 off for 10 seconds before activating the fluorescence excitation source 510 again. When the fluorescence reaches a desired level stored in memory for the desired sterilization process (that is, steam) the circuit board 500 analyzes the data and displays a result to a user on the housing 100 or the sterilization indicator reading apparatus 10.

[0152] In one or more embodiments of the present disclosure, the preset profiles of block 850 and block 880 are different temperature set points, incubation times, or any other suitable parameter change to determine the effectiveness of a desired sterilization process.EXEMPLARY EMBODIMENTS

[0153] The following is a list of exemplary embodiments according to the present disclosure, the numbering of which is not to be construed as designating levels of importance.

[0154] Embodiment 1 is a sterilization indicator reading apparatus, comprising: a housing comprising a top portion, a bottom portion opposite the top portion, and a major side portion; a well disposed into the housing and oriented along a well axis extending from a well open end to a well bottom end, wherein the well comprises a first region and a second region, and the first region and the second region are spaced apart along the well axis, and wherein the well is configured to receive at least a portion of a biological indicator; a heater thermally coupled to a portion of the well; a first printed circuit board disposed within the housing and parallel with the well axis, the first printed circuit board further comprising: a first fluorescence excitation source and a first white light source configured to direct light into the first region of the well; a first color sensor configured to measure the fluorescence and detect the color in the first region of the well; wherein the first fluorescent excitation source, the first white light source, the first color sensor on the first printed circuit board adjacent to the first region, a second white light source configured to direct white light into the second region in the well; a second color sensor optically communicative within the second region in the well, wherein the second white light source and the second color sensor are disposed on the first printed circuit board adjacent to the second region; and a controller circuit comprising a processor and a memory, wherein the heater, the first fluorescence excitation source, the first white light source, the first color sensor, the second white light source, and the second color sensor are communicatively coupled to the processor.

[0155] Embodiment 2 is the sterilization indicator reading apparatus of Embodiment 1, wherein a plurality of wells are disposed within the housing.

[0156] Embodiment 3 is the sterilization indicator reading apparatus of Embodiment 2, wherein each of the plurality of wells within the housing are optically communicative with at least a first fluorescence excitation source, a first white light source, a first color sensor, a second white light source, and a second color sensor.

[0157] Embodiment 4 is the sterilization indicator reading apparatus of Embodiments 2 or 3, wherein the first printed circuit board comprises a plurality of excitation sources, a plurality of white light sources, and a plurality of color sensors which are in optical communication with the plurality of wells within the housing.

[0158] Embodiment 5 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the first white light source or the second white light source is a light emitting diode.

[0159] Embodiment 6 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the second color sensor detects when a biological indicator is present in the well.

[0160] Embodiment 7 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the second color sensor detects when a biological indicator is not present in the well.

[0161] Embodiment 8 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the memory of controller circuit comprises one or more preset heating profdes.

[0162] Embodiment 9 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the memory of controller circuit comprises two or more preset heating profdes.

[0163] Embodiment 10 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the controller executes a preset heating profde in response to a reading value of the second color sensor.

[0164] Embodiment 11 is a sterilization indicator system, comprising: the sterilization indicator reading apparatus of Embodiment 1 ; and a biological indicator configured to be received at least partially within the well of the sterilization indicator reading apparatus, the biological indicator comprising: a transparent outer tube; an ampoule disposed within the transparent outer tube containing a fluorescently responsive substance; a breaker element disposed within the transparent outer tube and at least partially surrounding the ampoule, wherein the breaker element further comprises a color indicator, and wherein the color indicator is optically communicative with the second color sensor and the second white light source of the sterilization indicator reading apparatus, wherein the breaker element is aligned with the second region of the well; and a plurality of spores disposed within the transparent outer tube and aligned with the first region of the well.

[0165] Embodiment 12 is the sterilization indicator system of Embodiments 11, wherein the breaker element is configured to reflects a visible light wavelength from 380 nm to 750 nm.

[0166] Embodiment 13 is the sterilization indicator system of cl Embodiments aims 11 or 12, wherein the second color sensor further comprises an infrared sensor.

[0167] Embodiment 14 is the sterilization indicator system of any of Embodiments 11 to 13, wherein the transparent outer tube transmits greater than 50% of visible light incident on the transparent outer tube.

[0168] Embodiment 15 is the sterilization indicator system of any of Embodiments 11 to 14, wherein the first excitation source and the first color sensor of the sterilization indicator reading apparatus are optically communicative with the plurality of spores in fluid communication with a fluorescently responsive substance.

[0169] Embodiment 16 is a method of using the sterilization indicator system of Embodiment 11, the method comprising: disposing the biological indicator at least partially within the well of the sterilization indicator reading apparatus; activating the second white light source to reflect the color of the color indicator to the second color sensor of the sterilization indicator reading apparatus; communicating a color indicator reading value of the second color sensor to the controller of the sterilization indicator reading apparatus; and activating a preset heating profile in response to the color indicator reading value of the second color sensor.

[0170] Embodiment 17 is the method of Embodiment 16, wherein determining when the color indicator reading value is one of a plurality of preset colors indicators.

[0171] Embodiment 18 is the method of any one of Embodiments 16 or 17, wherein the color indicator is a brown color.

[0172] Embodiment 19 is the method of any one of Embodiments 16 to 18, wherein the color indicator is a blue color.

[0173] Embodiment 20 is the method of any one of Embodiments 16 to 19, wherein the color indicator is a pink color.

[0174] Embodiment 21 is the method of any one of Embodiments 16 to 20, wherein when a color indicator reading value is not one of a plurality of preset color indicators the sterilization indicator reading apparatus indicates an error.

[0175] Embodiment 22 is the method of Embodiment 21 , wherein the error indicated by the sterilization indicator reading apparatus prevents activation of the heater.

[0176] Embodiment 23 is the method of any one of Embodiments 16 to 22, wherein the memory of the sterilization indicator reading apparatus comprises instructions when a biological indicator is recognized in a well the controller activates the sterilization indicator reading apparatus.

[0177] Embodiment 24 is the method of any one of Embodiments 16 to 23, wherein the memory of the sterilization indicator reading apparatus comprises instructions when a biological indicator is recognized in a well the controller displays the type of biological indicator.

[0178] Embodiment 25 is the method of any one of Embodiments 16 to 24, wherein when the color is recognized by the second color sensor the controller activates a predetermined fluorescence reading.

[0179] Embodiment 26 is the method of any one of Embodiments 16 to 25, wherein determining whether the sterilization indicator reading apparatus indicates a successful sterilization cycle based on a fluorescence reading.

[0180] Embodiment 27 is the method of any one of Embodiments 16 to 26, wherein the fluorescence reading is a purple color.

[0181] Embodiment 28 is the method of any one of Embodiments 16 to 27, wherein the method further comprises a first time to determine when a biological indicator is in the well, wherein the first time is less than 1 second.

[0182] Embodiment 29 is the method of any one of Embodiments 16 to 28, wherein a second time is to determine the color of the breaker element of a biological indicator in the well, wherein the second time is less than 1 second.

[0183] Embodiment 30 is the sterilization indicator reading apparatus of any one of Embodiments 1-15, wherein the first region is optically isolated from the second region.

Claims

CLAIMS1. A sterilization indicator reading apparatus, comprising: a housing comprising atop portion, a bottom portion opposite the top portion, and a major side portion; a well disposed into the housing and oriented along a well axis extending from a well open end to a well bottom end, wherein the well comprises a first region and a second region, and the first region and the second region are spaced apart along the well axis, and wherein the well is configured to receive at least a portion of a biological indicator; a heater thermally coupled to a portion of the well; a first printed circuit board disposed within the housing and aligned with the well axis, the first printed circuit board further comprising: a first fluorescence excitation source and a first white light source configured to direct light into the first region of the well; a first color sensor configured to measure the fluorescence and detect the color in the first region of the well; wherein the first fluorescent excitation source, the first white light source, the first color sensor on the first printed circuit board adjacent to the first region, a second white light source configured to direct white light into the second region in the well; a second color sensor optically communicative within the second region in the well, wherein the second white light source and the second color sensor are disposed on the first printed circuit board adjacent to the second region; and a controller circuit comprising a processor and a memory, wherein the heater, the first fluorescence excitation source, the first white light source, the first color sensor, the second white light source, and the second color sensor are communicatively coupled to the processor.

2. The sterilization indicator reading apparatus of claim 1, wherein a plurality of wells are disposed within the housing.

3. The sterilization indicator reading apparatus of claim 2, wherein each of the plurality of wells within the housing are optically communicative with at least a first fluorescence excitation source, a first white light source, a first color sensor, a second white light source, and a second color sensor.

4. The sterilization indicator reading apparatus of any one of claims 2 or 3, wherein the first printed circuit board comprises a plurality of excitation sources, a plurality of white light sources, anda plurality of color sensors which are in optical communication with the plurality of wells within the housing.

5. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the first white light source or the second white light source is a light emitting diode.

6. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the second color sensor detects when a biological indicator is present in the well.

7. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the second color sensor detects when a biological indicator is not present in the well.

8. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the memory of controller circuit comprises one or more preset heating profiles.

9. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the memory of controller circuit comprises two or more preset heating profiles.

10. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the controller executes a preset heating profile in response to a reading value of the second color sensor.

11. A sterilization indicator system, comprising: the sterilization indicator reading apparatus of claim 1 ; and a biological indicator configured to be received at least partially within the well of the sterilization indicator reading apparatus, the biological indicator comprising: a transparent outer tube; an ampoule disposed within the transparent outer tube containing a fluorescently responsive substance; a breaker element disposed within the transparent outer tube and at least partially surrounding the ampoule, wherein the breaker element further comprises a color indicator, and wherein the color indicator is optically communicative with the second color sensor and the second white light source of the sterilization indicator reading apparatus, wherein the breaker element is aligned with the second region of the well; and a plurality of spores disposed within the transparent outer tube and aligned with the first region of the well.

12. The sterilization indicator system of claim 11, wherein the breaker element is configured to reflects a visible light wavelength from 380 nm to 750 nm.

13. The sterilization indicator system of claims 11 or 12, wherein the second color sensor further comprises an infrared sensor.

14. The sterilization indicator system of any of claims 11 to 13, wherein the transparent outer tube transmits greater than 50% of visible light incident on the transparent outer tube.

15. The sterilization indicator system of any of claims 11 to 14, wherein the first excitation source and the first color sensor of the sterilization indicator reading apparatus are optically communicative with the plurality of spores in fluid communication with a fluorescently responsive substance.

16. A method of using the sterilization indicator system of claim 11, the method comprising: disposing the biological indicator at least partially within the well of the sterilization indicator reading apparatus; activating the second white light source to reflect the color of the color indicator to the second color sensor of the sterilization indicator reading apparatus; communicating a color indicator reading value of the second color sensor to the controller of the sterilization indicator reading apparatus; and activating a preset heating profile in response to the color indicator reading value of the second color sensor.

17. The method of claim 16, wherein determining when the color indicator reading value is one of a plurality of preset colors indicators.

18. The method of any one of claims 16 or 17, wherein the color indicator is a brown color.

19. The method of any one of claims 16 to 18, wherein the color indicator is a blue color.

20. The method of any one of claims 16 to 19, wherein the color indicator is a pink color.

21. The method of any one of claims 16 to 20, wherein when a color indicator reading value is not one of a plurality of preset color indicators the sterilization indicator reading apparatus indicates an error.

22. The method of claim 21, wherein the error indicated by the sterilization indicator reading apparatus prevents activation of the heater.

23. The method of any one of claims 16 to 22, wherein the memory of the sterilization indicator reading apparatus comprises instructions when a biological indicator is recognized in a well the controller activates the sterilization indicator reading apparatus.

24. The method of any one of claims 16 to 23, wherein the memory of the sterilization indicator reading apparatus comprises instructions when a biological indicator is recognized in a well the controller displays the type of biological indicator.

25. The method of any one of claims 16 to 24, wherein when the color is recognized by the second color sensor the controller activates a predetermined fluorescence reading.

26. The method of any one of claims 16 to 25, wherein determining whether the sterilization indicator reading apparatus indicates a successful sterilization cycle based on a fluorescence reading.

27. The method of any one of claims 16 to 26, wherein the fluorescence reading is a purple color.

28. The method of any one of claims 16 to 27, wherein the method further comprises a first time to determine when a biological indicator is in the well, wherein the first time is less than 1 second.

29. The method of any one of claims 16 to 28, wherein a second time is to determine the color of the breaker element of a biological indicator in the well, wherein the second time is less than 1 second.

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