Sterilization indicator reading apparatus with rapid time response

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 heater sleeve that is thermally coupled within and configured to rapidly heat a biological indicator and provide rapid results of the effectiveness of a sterilization process. The heater sleeve is communicatively coupled with a printed circuit board that controls the heating profile of a biological indicator depending on the desired heating time and desired temperature to provide rapid results of the effectiveness of a sterilization process.

Description

PA100400W002STERILIZATION INDICATOR READING APPARATUS WITH RAPID TIME RESPONSEBACKGROUND

[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 at least one of the source metabolism and growth indicating the sterilization process was effective in destroying all of 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 utilizes 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 presetincubation heating profile or time within the sterilization indicator reading apparatus. Some sterilization indicator reading apparatuses may require an extended time to heat up the biological indicator, thus causing a delay in obtaining results of a sterilization process. Some sterilization indicator reading apparatuses may take over thirty minutes to heat the sample to a desired temperature.SUMMARY

[0008] The present disclosure provides various embodiments of a sterilization indicator reading apparatus including a heater sleeve configured to rapidly heat a biological indicator to a desired temperature.

[0009] It may be desirable for a sterilization indicator reading apparatus to reduce the time to heat a biological indicator in a well, thereby reducing the time to obtain results. For example, conventional incubators may take up to 20 minutes to reach the setpoint temperature. It may be desirable for a sterilization indicator reading apparatus to independently control the heat profile of each well to measure the effectiveness of different types of biological indicators. It may be desirable for a sterilization indicator reading apparatus to provide a heater sleeve with rapid heating allowing the user to shut the heat off when not using the sterilization indicator reading apparatus to save energy.

[0010] In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus includes a housing that includes a top portion, a bottom portion opposite the top portion, and a major side portion. The housing further includes a well disposed into the housing and at least partially defined by a heater sleeve. The well and the heater sleeve are oriented along a well axis extending from a well open end to a well bottom end. The well is configured to receive at least a portion of a biological indicator. The sterilization indicator reading apparatus further includes a heater element coupled to the heater sleeve and an insulating layer coupled to the heater sleeve and the heater element. The heater sleeve includes a first thermal sensor disposed on the heater sleeve. The sterilization indicator reading apparatus further includes a first printed circuit board. The printed circuit board includes a first fluorescence excitation source, a first color sensor, and a first white light source. The first fluorescence excitation source is configured to excite a fluorescently excitable substance in the well. The first color sensor is configured to measure a fluorescence and detect a color in the well. The first white light source is configured to direct light into the well. The printed circuit board further includes a controller circuit including a controller and a memory. The controller and memory are communicatively coupled with the heater sleeve, the heater element, and the first thermal sensor.

[0011] In one or more embodiments of the present disclosure, a sterilization indicator reading apparatus system includes a sterilization indicator reading apparatus described herein and a biological indicator configured to be received at least partially within the heater sleeve and the well of the sterilization indicator reading apparatus. The biological indicator includes a transparent outer tube, a breaker element at least partially surrounding an ampoule and comprising a color indicator, where the ampoule includes a fluorescently responsive substance, and a plurality of spores.

[0012] In one or more embodiments of the present disclosure, a method of using the sterilization indicator reading apparatus system includes disposing the biological indicator at least partially within the heater sleeve and the well of the sterilization indicator reading apparatus. Next, the temperature of the biological indicator communicates with the first thermal sensor disposed on the heater sleeve to the controller which activates a preset heating profile in response to a reading of the first thermal sensor to control a temperature heater sleeve. The temperature of the biological indicator then communicates with the first thermal sensor disposed on the heater sleeve to the controller of the sterilization indicator reading apparatus and deactivates the heater sleeve.

[0013] Some advantages the sterilization indicator reading apparatus of the present disclosure provides are reducing time to heat a biological indicator in a well and thus reducing time to obtain results, independently controlling the heat profile of each well to measure the effectiveness of different types of biological indicators, and providing a heater sleeve with rapid heating allowing the user to shut the heat off when not using the sterilization indicator reading apparatus to save energy.

[0014] 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.

[0015] 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.

[0016] 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 preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure.

[0017] 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.” Thephrases “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.

[0018] As used herein, the term “or” is generally employed in its usual sense including“and / or” unless the content clearly dictates otherwise.

[0019] The term “and / or” means one or all of the listed elements or a combination of any two or more of the listed elements.

[0020] 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).

[0021] 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.).

[0022] 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

[0023] Throughout the specification, reference is made to the appended drawings, where like reference numerals designate like elements, and wherein:

[0024] FIG. 1 is a perspective view of an embodiment of a sterilization indicator reading apparatus;

[0025] FIG. 2A is a perspective view of a biological indicator in a heater sleeve of the sterilization indicator reading apparatus of FIG. 1 ;

[0026] FIG. 2B is a cross-sectional view of the biological indicator in the heater sleeve of FIG. 2A;

[0027] FIG. 2C is a perspective view of a biological indicator in a heater sleeve disposed in the sterilization indicator reading apparatus of FIGS. 1 to 2B;

[0028] FIG. 2D is a schematic side-elevation view of the printed circuit board and a well of the sterilization reading apparatus of FIGS. 1 to 2C;

[0029] FIG. 3A is a perspective view of an embodiment of a biological indicator in a heater sleeve;

[0030] FIG. 3B is a top view of the biological indicator in the heater sleeve of FIG. 3A;

[0031] FIG. 3C is a cross-sectional view of the biological indicator in the heater sleeve of FIGS.3A to 3B;

[0032] FIG. 3D is a perspective view of the heater sleeve of FIGS. 3A to 3C disposed in an embodiment of a sterilization indicator reading apparatus;

[0033] FIG. 4 is a flow diagram of one embodiment of heating control of any one of FIGS. 1 to 3D;

[0034] FIG. 5A is a temperature profde of a biological indicator disposed in a conventional heater block of a sterilization indicator reading apparatus and a temperature profde of a biological indicator disposed in a heater sleeve of FIGS. 1 to 4;

[0035] FIG. 5B is a heating profde of a biological indicator disposed in one embodiment of a heater sleeve of any one of FIGS. 1 to 4; and

[0036] FIG. 5C is a heating profde of a biological indicator disposed in a heater block of a conventional sterilization indicator reading apparatus.DETAILED DESCRIPTION

[0037] The present disclosure provides various embodiments of a sterilization indicator reading apparatus including a heater sleeve configured to rapidly heat a biological indicator to a desired temperature.

[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 sleeve is thermally coupled within each well. The heater sleeve is configured to rapidly heat a biological indicator and provide results of the effectiveness of a sterilization process.

[0039] It may be desirable for a sterilization indicator reading apparatus to heat a biological indicator quickly and reliably to determine the effectiveness of a sterilization process. In one or more embodiments of the present disclosure, the heater sleeve of the sterilization reading apparatus heats the heater sleeve at a rate of 100 degrees per minute.

[0040] It may further be desirable to have a plurality of wells to heat multiple samples at the same time. In an embodiment of the present disclosure, the sterilization reading apparatus has two or more wells configured to receive a biological indicator.

[0041] It may be further desirable to have the ability to heat each well independently. In one or more embodiments of the present disclosure, the heater sleeve of the sterilization reading apparatus is controlled by a printer circuit board independently of other heater sleeves.

[0042] It may further be desirable to have a sterilization indicator reading apparatus with a compact and reliable heater sleeve. In one or more embodiments of the present disclosure, the heater sleeve of the sterilization reading apparatus is formed of sheet metal with a thickness of less than 2 millimeters or less than 1.5 millimeters or ranging from 750 micrometers to 1250 micrometers.

[0043] In may further be desirable to have a sterilization indicator reading apparatus with an energy saving mode (that is, allowing the user to shut the heater sleeve off when not using it) and still heat a biological indicator rapidly when needed. In one or more embodiments of the present disclosure, the heater sleeve of the sterilization reading apparatus has a low thermal mass allowing the heater sleeve to increase from 27 Celsius to 60 Celsius in less time, when compared to a conventional sterilization indicator reading apparatus.

[0044] 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 indicative of the effectiveness of the sterilization process. Moreover, conventional reading apparatuses may utilize 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.

[0045] 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.

[0046] 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.

[0047] 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 top portions, side portions, and bottom potions. In one or more embodiments of the present disclosure, the sterilization indicator reading apparatus includes atop portion, a side portion, and bottom portion.

[0048] A sterilization indicator may include any suitable mechanical components. Examples of suitable mechanical components include wells, covers, vents, graspable portions, filters, spacers, or any other mechanical component 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, heater blocks, heater sleeves, or any other electrical component to assist with determining the effectiveness of a sterilization process in a reliable and timely manner.

[0049] 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.

[0050] 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 sleeve. In some embodiments, the well may be defined by a portion of the heater sleeve and a portion of a transparent material.

[0051] 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 (for example, time, temperature). 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.

[0052] 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.

[0053] The sterilization indicator reading apparatus includes a heater sleeve disposed in the housing. In one or more embodiments presented herein, the sterilization indicator reading apparatus includes any suitable number of heater sleeves coupled to any number of wells. The heater sleeve may be disposed in any suitable position within the housing. In some embodiments, the heater sleeve is coupled with a well. In some embodiments, the heater sleeve forms a part of the well with the housing. In some embodiments, the heater sleeve at least partially surrounds the well of the sterilization indicator reading apparatus.

[0054] The term “sleeve” as provided herein refers to a having a shape designed to fit at least partially around an article taking the form of the article. The sleeve may have a length along a longitudinal axis, a diameter, and a thickness. The length of the sleeve is more than twice the diameter of the sleeve. The sleeve thickness may be less than 10% of the sleeve diameter.

[0055] The term “thickness of the heater sleeve” and variations thereof refers to the lateral distance between a first major surface of an article and a second major surface of an article. The first major surface is a surface that is at least 40% of the total surface area of an article. The second major surface is a surface that is at least 40% of the total surface area of an article. The first major surface of the heater sleeve may define an outer surface of the sleeve. The second major surface of the heater sleeve may define an inner surface of the sleeve.

[0056] The term “length of the heater sleeve” and variations thereof refers to the lateral distance of the well defined by the heater sleeve that is configured to fit at least partially around an article.

[0057] The heater sleeve may be formed by any suitable heat conductive material. Examples of suitable materials include metals, thermally conductive polymers, ceramics, non-thermally conductive polymers, or any combination of two or more. In addition, the heater sleeve may be any suitable shape or size. Specifically, the heater sleeve may be any suitable thickness configured to rapidly heater the well of a sterilization indicator reading apparatus.

[0058] The heater sleeve may be coupled to a heater element that is thermally coupled within the well of a sterilization indicator reading apparatus. 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, silicone heaters, ceramic heaters, radiative heaters, or any combination of two or more. The heater sleeve may include any number of heater elements suitable for heating and maintaining a desired temperature.

[0059] The heater sleeve may further be coupled to a temperature sensor. 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 sleeve.

[0060] The heater sleeve may be coupled to 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. The insulating layer may be disposed in any suitable location on the heater sleeve. In some embodiments, the insulating layer may be disposed on the exterior surface of the heater sleeve. In some embodiments, the insulating layer may be disposed within the heater sleeve.

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

[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 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 any suitable 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 componentmay 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 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.

[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 suitablelocation 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 operates in a wavelength range from 380 nanometers to 750 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, a self-contained ampoule, 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 organisms.

[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 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 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 an 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-methy lumbellifery 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 (mb) or less, 0.7 mE or less, 0.6 mE or less, 0.5 mE or less, 0.4 mE or less, 0.3 mE or less, or 0.2 mE or less. In one or more embodiments of the present disclosure, the volume of the fluorescently responsive substrate may be 0.1 mE or greater, 0.2 mE or greater, 0.3 mE or greater, 0.4 mE or greater, 0.5 mE or greater, 0.6 mE or greater, or 0.7 mE or greater. In one or more embodiments of the present disclosure, the volume of the fluorescently responsive substrate may be 0. 1 mE to 0.8 mb, 0.3 mE to 0.7 m , 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. Examples of suitable transparent materials include glass, plastic, ceramic, or any other transparent material. 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, pierced, crushed, cracked, or broken.

[0088] In one or more embodiments of the present disclosure, the breaker element is a color indicator. The color indicator may be any suitable wavelength from 380 nanometers to 750 nanometers. The breaker element may be any suitable material. Examples of suitable materials includes plastic, 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 ampoule 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. 1 is a perspective view of one embodiment of a sterilization indicator reading apparatus 10 including a housing 100. The housing 100 includes a top portion 110, a bottom portion 120 opposite the top portion, 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 embodiments of the present disclosure the well 150 may include a well opening 152 defined by the top portion of the surface. 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 materialmay 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 130 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 130 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, or friction fitting.

[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 some embodiments, 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 anyother 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 of a biological indicator 200. FIGS. 2A-2D

[0099] FIGS. 2A-2C are various views of one embodiment of a heater sleeve 180 of an embodiment of a sterilization indicator reading apparatus 10 including a biological indicator tube 210. The biological indicator 200 is at least partially disposed in the heater sleeve 180. In some embodiments the biological indicator 200 may be disposed entirely within the heater sleeve 180.

[0100] The heater sleeve 180 may form any suitable amount of a well 150 of a sterilization indicator reading apparatus 10. The amount the heater sleeve 180 forms may be expressed by a percentage of the total surface area of the well 150 that the biological indicator 200 may be positioned in. In some embodiments, the heater sleeve 180 forms 25 percent or less, 30 percent or less of the surface area of the well, 35 percent or less of the surface area of the well, or 40 percent or less of the surface area of the well.

[0101] The heater sleeve 180 may be formed by any suitable material. Suitable materials for heating a well of a biological indicator may include materials that have a high thermal conductivity and a low thermal mass. Examples of suitable materials include metals, ceramics, polymers, or any combination of two or more. In some embodiments, the heater sleeve material is sheet metal formed at least partially around the well of the sterilization indicator reading apparatus. In some embodiments, the heater sleeve material has a thermal conductivity of at least 50 W / mK or greater, at least 75 W / mK or greater, or at least 100 W / mK or greater. In some embodiments, the heater sleeve material has a thermal conductivity of 125 W / mK or less, 100 W / mK or less, or 75 W / mK or less. In some embodiments, the heater sleeve material has a thermal conductivity between 50 W / mK and 125 W / mK. In some embodiments, the heater sleeve material has a thermal conductivity between 75 W / mK and 125 W / mK. In some embodiments, the heater sleeve material has a thermal conductivity between 80 W / mK and 110 W / mK. In some embodiments, the heater sleeve material has a thermal conductivity between 95 W / mK and 105 W / mK.

[0102] In addition, the heater sleeve 180 may be any suitable shape or size. Specifically, the heater sleeve 180 may be any suitable thickness configured to rapidly heater the well of a sterilization indicator reading apparatus. The thickness T180 of the heater sleeve 180 extends from the surface ofthe heater sleeve 180 in contact with the biological indicator 200 to the outer surface 181 of the heater sleeve 180.

[0103] In some embodiments, the thickness T180 of the heater sleeve is 200 pm or greater, 300 pm or greater, 400 pm or greater, 500 or greater, 600 pm or greater, 700 pm or greater, 800 pm or greater, 900 pm or greater, 1000 pm or greater, 1100 pm or greater, 1200 pm or greater. In some embodiments, the thickness T180 of the heater sleeve is 2000 pm or less, 1500 pm or less 1250 pm or less, 1200 pm or less, 1100 pm or less, 1000 pm or less, 900 pm or less, 800 pm or less, 700 pm or less, 600 pm or less, 500 pm or less, 400 pm or less, 300 pm or less. In some embodiments, the thickness T180 of the heater sleeve is between 250 pm and 1250 pm. In some embodiments, the thickness T180 of the heater sleeve is between 750 pm and 1250 pm. In some embodiments, the thickness T180 of the heater sleeve is between 500 pm and 800 pm. In some embodiments, the thickness T180 of the heater sleeve is between 700 pm and 800 pm.

[0104] The heater sleeve 180 may be expressed as a ratio of the heater sleeve thickness T180 to the length of the well 150.

[0105] In some embodiments, the ratio of the heater sleeve thickness T180 to the length of the heater sleeve L180 is 0. 1 or less, 0.05 or less, or 0.025 or less. In some embodiments, the ratio of the heater sleeve thickness T180 to the length of the heater sleeve L180 is 0.01 or greater, 0.025 or greater, or 0.049 or greater.

[0106] The length of the heater sleeve LI 80 is measured by the distance from the bottom of the biological indicator within the heater sleeve to the topmost portion of the biological indicator within the heater sleeve.

[0107] The heater sleeve 180 includes an aperture 190 that defines an opening. The aperture 190 may be any suitable shape or size to facilitate optical communication with at least a part of the biological indicator 200 which is disposed in the heater sleeve 180. In some embodiments, the aperture 190 is configured to provide a window for a plurality of light sources, a plurality of excitation sources, and a plurality of sensors to optically communicate with the biological indicator 200 disposed within the heater sleeve 180.

[0108] 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, a self-contained ampoule, 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.

[0109] 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.

[0110] Disposed 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 may include a color indicator. This feature may provide the desired result of communicating the biological indicator type to the sterilization indicator reading apparatus 10.

[0111] The ampoule 230 contains a fluorescently responsive substrate. To release the fluorescently responsive substrate from the ampoule 230 the breaker element 220 punctures the ampoule 230 to allow the fluorescently responsive substrate to flow into fluid communication with a plurality of spores 250 viewable through the aperture 190 of the heater sleeve 180. The ampoule may contain any suitable volume of a fluorescently responsive substrate.

[0112] FIG. 2C is a perspective view of one embodiment of the a biological indicator in a heater sleeve disposed in the sterilization indicator reading apparatus of FIGS. 1 to 2B. The sterilization indicator reading apparatus 10 includes a well 150 formed at least partially by the heater sleeve 180 wherein a biological indicator 200 is disposed. Furthermore, the sterilization indicator reading apparatus 10 includes a printed circuit board 500 that is adjacent to and aligned with the well 150 and heater sleeve 180. In some embodiments, the aperture 190 of the heater sleeve 180 provides the printed circuit board 500 to optically communicate with the biological indicator 200 disposed in the well 150.

[0113] 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.

[0114] When used herein, the term “aligned” 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” 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.

[0115] In some embodiments the heater sleeve 180 is connected to the housing 100 of the sterilization indicator reading apparatus 10. In some embodiments, the heater sleeve 180 is connected to the printed circuit board 500. Any suitable technique may be used to connect the heater sleeve 180to the printed circuit board 500. Examples of suitable techniques may include mechanically fastening, welding, adhesively connecting, friction fitting, or any other suitable technique.

[0116] In some embodiments, the heater sleeve 180 is thermally isolated from an adjacent heater sleeve within the housing 100. In such a configuration, each heater sleeve may be independently controlled. As a result, the sterilization indicator reading apparatus may simultaneously read a plurality of biological indicators operating one or more different heating profiles. The heater sleeves 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 heater sleeves 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.

[0117] FIG. 2D is a schematic diagram of one embodiment of a printed circuit board and a well of the sterilization reading apparatus of FIGS. 1-2C. 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 defined by the top portion surface 112 through the second region 170 and then through the first region 160 to the bottom well end 156.

[0118] The printed circuit board 500 includes a first fluorescence excitation source 510, a second fluorescence excitation source 512, and a first white light source 520 configured to direct light into the first region 160 of the well. A first color sensor 530 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 white light source 522 configured to direct white 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.

[0119] The printed circuit board may include any suitable number of fluorescent excitation sources, white light sources, and color sensors to provide an effective reading of a biological indicator 200.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] 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 sleeve 180, the first fluorescence excitation source 510, the second fluorescence excitation source 512, the first white light source 520, the first color sensor 530, the second white light source 522, and the second color sensor 532.

[0129] The printed circuit board 500 (that is, the processor and memory) may include algorithms 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.

[0130] In one or more embodiments of the present disclosure, the memory includes a plurality of preset heating profdes. The heating profiles are discussed in further detail herein.

[0131] In FIGS. 3A-3C, various view of one embodiment of the heater sleeve 180 from another embodiment of a sterilization indicator reading apparatus are provided. FIG. 3A is a perspective view of one embodiment of a biological indicator 200 disposed in a heater sleeve 180. The heater sleeve 180 at least partially surrounds the biological indicator 200. In some embodiments, the heater sleeve entirely surrounds the biological indicator.

[0132] The heater sleeve 180 may form or define any suitable amount of a well 150 of a sterilization indicator reading apparatus 10. The amount the heater sleeve 180 forms may be expressed by a percentage of the total surface area of the well 150 that the biological indicator 200 may be positioned in. In some embodiments, the heater sleeve 180 forms 25 percent or less, 30 percent or less of the surface area of the well, 35 percent or less of the surface area of the well, 40 percent or less of the surface area of the well, 45 percent or less of the surface area of the well, or 50 percent or less of the surface area of the well. In some embodiments, the heater sleeve 180 forms or defines 10% to 50% of the surface area of the well. In some embodiments, the heater sleeve 180 forms or defines 15% to 25% of the surface area of the well. In some embodiments, the heater sleeve 180 forms or defines 20% to 25% of the surface area of the well.

[0133] The heater sleeve 180 is coupled to an insulating portion 184 which at least partially surrounds the biological indicator 200. The insulating portion 184 may be any suitable material. Examples of insulating materials include fiberglass, foam, wool, cellulose, aerogel, or any other suitable insulator. The insulating portion 184 may be any suitable size or shape. In some embodiments, the insulating portion 184 forms a cavity configured to position a biological indicator 200 within the cavity. In some embodiments, the insulating portion 184 may be connected to other portions of the well. In some embodiments, the insulating portion 184 may be connected to the printed circuit board 500. In some embodiments, the insulating portion 184 may be connected to a housing of the sterilization indicator reading apparatus.

[0134] The heater sleeve 180 may be formed by any suitable heat conductive material. Suitable materials for heating a well of a biological indicator may include materials that have a high thermal conductivity and a low thermal mass. Examples of suitable materials include metals, ceramics, polymers, or any combination of two or more. In some embodiments, the heater sleeve material is sheet metal formed at least partially around the well of the sterilization indicator reading apparatus. Insome embodiments, the heater sleeve material has a thermal conductivity of at least 50 W / mK or greater, at least 75 W / mK or greater, at least 100 W / mK or greater, at least 125 W / mK or greater, at least 150 W / mK or greater, at least 175 W / mK or greater, at least 200 W / mK or greater, at least 225 W / mK or greater, or at least 250 W / mK or greater. In some embodiments, the heater sleeve material has a thermal conductivity of 275 W / mK or less, 250 W / mK or less, 225 W / mK or less, 200 W / mK or less, 175 W / mK or less, 150 W / mK or less, 125 W / mK or less, 100 W / mK or less, or 75 W / mK or less. In some embodiments, the heater sleeve material has a thermal conductivity between 50 W / mK and 125 W / mK. In some embodiments, the heater sleeve material has a thermal conductivity between 75 W / mK and 125 W / mK. In some embodiments, the heater sleeve material has a thermal conductivity between 130 W / mK and 245 W / mK. In some embodiments, the heater sleeve material has athermal conductivity between 50 W / mK and 275 W / mK.

[0135] In addition, the heater sleeve 180 may be any suitable shape or size. Specifically, the heater sleeve 180 may be any suitable thickness configured to rapidly heater the well of a sterilization indicator reading apparatus. The thickness T180 of the heater sleeve 180 extends from the inner major surface of the heater sleeve 180 that is in contact with the biological indicator 200 to the outer major surface 181 of the heater sleeve 180.

[0136] In some embodiments, the thickness T180 of the heater sleeve is 200 pm or greater, 300 pm or greater, 400 pm or greater, 500 or greater, 600 pm or greater, 700 pm or greater, 800 pm or greater, 900 pm or greater, 1000 pm or greater, 1100 pm or greater, 1200 pm or greater, 1500 pm or greater, 1750 pm or greater, or 1900 pm or greater. In some embodiments, the thickness T180 of the heater sleeve is 2000 pm or less, 1750 pm or less, 1500 pm or less, 1250 pm or less, 1200 pm or less, 1100 pm or less, 1000 pm or less, 900 pm or less, 800 pm or less, 700 pm or less, 600 pm or less, 500 pm or less, 400 pm or less, or 300 pm or less. In some embodiments, the thickness T180 of the heater sleeve is between 250 pm and 2000 pm. In some embodiments, the thickness T180 of the heater sleeve is between 750 pm and 1250 pm. In some embodiments, the thickness T180 of the heater sleeve is between 500 pm and 800 pm. In some embodiments, the thickness T180 of the heater sleeve is between 700 pm and 800 pm.

[0137] The heater sleeve 180 may be expressed as a ratio of the heater sleeve thickness T180 to the length of the well 150. In some embodiments, the ratio of the heater sleeve thickness T180 to the length of the heater sleeve L180 is 0.1 or less, 0.05 or less, or 0.025 or less. In some embodiments, the ratio of the heater sleeve thickness T180 to the length of the heater sleeve L180 is 0.01 or greater, 0.025 or greater, or 0.049 or greater. In some embodiments, the ratio of the heater sleeve thickness T180 to the length of the heater sleeve L180 is 0.001 to 0.05, 0.02 to 0.045, 0.025 to 0.04, or 0.03 to 0.04. In

[0138] The heater sleeve 180 includes an aperture 190 that defines an opening. The aperture 190 may be any suitable shape or size to facilitate optical communication with at least a part of the biological indicator 200 which is disposed in the heater sleeve 180. In some embodiments, the aperture 190 is configured to provide a window for a plurality of light sources, a plurality of excitation sources, and a plurality of sensors to optically communicate with the biological indicator 200 disposed within the heater sleeve 180.

[0139] In one or more embodiments of the present disclosure, connected to the insulating portion 184 is a heater sleeve 180 and connected to the heater sleeve 180 is the heater element 188. The heater element 188 is thermally coupled with the heater sleeve 180. A heater element 188 may be any suitable heating element. Examples of suitable heater elements include polyimide heaters, resistive heaters in silicone, immersion resistive heaters, Peltier devices, silicone heaters, ceramic heaters, radiative heaters, or any combination of two or more.

[0140] The present disclosure may include any other suitable heater sleeve 180 configurations sufficient to heat the biological indicator 200 in a sterilization indicator reading apparatus. In some embodiments, a suitable heater sleeve 180 may include radiative heat, water jacket heaters, infrared heaters, or any combination of two or more.

[0141] FIGS. 3B to 3C show atop view and a corresponding cross-sectional view of the biological indicator in the heater sleeve of FIG. 3A. Wherein the biological indicator 200 is at least partially surrounded by the insulating portion 184 and in contact with the heater sleeve 180 such that when the heater sleeve 180 receives heat from the heating element 188 the biological indicator 200 receives thermal energy from the heater sleeve 180. The heater sleeve 180 maintains heat within the biological indicator 200 via the insulating portion 184 resisting heat transfer.

[0142] In some embodiments, the heater sleeve 180 may include one or more insulating portions 184 and heating elements 188. In one or more embodiments of the present disclosure the heater sleeve 180 includes a heating element 188 disposed in multiple locations. The present disclosure may include any number of heater elements 188 suitable for rapidly heating and maintaining a desired temperature.

[0143] The heater sleeve 180 may include one or more temperature sensors disposed on the heater sleeve 180. 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 sleeve.

[0144] FIG. 3D is a perspective view of the heater sleeve 180 of FIGS. 3A-3C disposed in another embodiment of a sterilization indicator reading apparatus 1000. The sterilization indicator reading apparatus 1000 includes a plurality of wells 1150, at least one printed circuit board 1500, anda housing 1100 which at least partially encloses the plurality of wells 150 and the printed circuit board 1500. A biological indicator 200 is disposed within a well 150. Each of the plurality of wells 150 include a heater sleeve 180 at least partially covered by an insulating layer 184. The first well has the insulating layer 184 removed to further clarify the heater sleeve shape 180.

[0145] In some embodiments, the heater sleeve 180 is thermally isolated from an adjacent heater sleeve in the housing. In such a configuration, each heater sleeve may be independently controlled. As a result, the sterilization indicator reading apparatus may simultaneously read a plurality of biological indicators. Moreover, the heater sleeves 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 heater sleeves 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.

[0146] FIG. 4 is a flow diagram of one embodiment of heating control of any one of FIGS. 1 to 3D. 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.

[0147] 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 capable of being controlled to a desired heating profile based on the biological indicator type.

[0148] In one or more embodiments of the present disclosure, activating the fluorescence detection cycle described in block 650 occurs in response to the second (pre-set) 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.

[0149] 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 heatercontrol 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.

[0150] 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.

[0151] 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, the controller 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.

[0152] 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 detectioncycle, 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.

[0153] 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.

[0154] FIG. 5 A is a temperature profile of the liquid in a biological indicator disposed in a conventional heater block of a sterilization indicator reading apparatus and a temperature profile of a biological indicator disposed in a heater sleeve 180 of FIGS. 1 to 4. The heater sleeve 180 increases the temperature of the liquid in the biological indicator disposed in the well from about 27 degrees Celsius to a desired temperature of 60 degrees Celsius in less than 100 seconds. The conventional heater block of a sterilization indicator reading apparatus increases the temperature of the liquid in the biological indicator disposed in a well from about 23 degrees Celsius to a desired temperature of 60 degrees Celsius in about 290 seconds.

[0155] FIG. 5B is a heating profile of the liquid in a biological indicator and a heater sleeve in one embodiment of a heater sleeve of any one of FIGS. 1 to 4. The heater sleeve 180 of FIGS. 1 to 4 increases temperature at a rate of at least 100 degrees Celsius per minute. The heater sleeve 180 decreases temperature at a rate of at least 30 degrees Celsius per minute. In some embodiments, the heater sleeve may increase temperature at a rate of at least 110 degrees Celsius per minute, at least 120 degrees Celsius per minute, at least 130 degrees Celsius per minute, at least 140 degrees Celsius per minute, or about 150 degrees Celsius per minute, the heater sleeve may increase temperature at a rate from 100 to 150 degrees Celsius per minute, 110 to 150 degrees Celsius per minute, 120 to 140 degrees Celsius per minute, or 130 to 140 degrees Celsius per minute.

[0156] The heater sleeve 180 of FIGS. 1 to 4 increases the temperature of the biological indicator disposed in the well from about 27 degrees Celsius to a desired temperature of 60 degrees Celsius in 120 seconds or less, 110 seconds or less, 100 seconds or less, 90 seconds or less, 80 seconds or less, or 70 seconds or less. In a preferred embodiment of the present disclosure, the heater sleeve 180 increases the temperature of the biological indicator disposed in the well from about 27 degrees Celsius to a desired temperature of 60 degrees Celsius in less than 60 seconds.

[0157] FIG. 5C is a heating profile of a biological indicator disposed in a heater block of a conventional sterilization indicator reading apparatus. The biological indicator increase temperature from about 23 degrees Celsius to a desired temperature of 60 degrees Celsius in about 300 seconds. The heating block of the conventional sterilization indicator reading apparatus, on average, increases temperature at a rate between 40 and 50 degrees Celsius per minute.EXEMPLARY EMBODIMENTS

[0158] 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.

[0159] 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 at least partially defined by a heater sleeve, the well and the heater sleeve oriented along a well axis extending from a well open end to a well bottom end, wherein the well is configured to receive at least a portion of a biological indicator; a heater element coupled to the heater sleeve; an insulating layer coupled to the heater sleeve and the heater element; a first thermal sensor disposed on the heater sleeve; and a first printed circuit board comprising: a first fluorescence excitation source and a first white light source configured to direct light into the well; a first color sensor configured to measure a fluorescence and detect a color in the well; and a controller circuit comprising a controller and a memory, wherein the controller is communicatively coupled with the heater sleeve, the heater element, and the first thermal sensor.

[0160] Embodiment 2 is the sterilization indicator reading apparatus of Embodiment 1, wherein the heater sleeve comprises a thickness from 750 micrometers to 1250 micrometers.

[0161] Embodiment 3 is the sterilization indicator reading apparatus of any one of Embodiments 1 or 2, wherein a plurality of wells are disposed within the housing.

[0162] Embodiment 4 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein each of the plurality of wells within the housing comprises a heater sleeve.

[0163] Embodiment 5 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the heater element further comprises a second thermal sensor.

[0164] Embodiment 6 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the heater sleeve at least partially defines a circumference of the well.

[0165] Embodiment 7 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the heater sleeve is formed by a heat conductive material.

[0166] Embodiment 8 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the controller comprises logic to control a temperature of the heater sleeve.

[0167] Embodiment 9 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, the first printed circuit board further comprises a second white light source and a second color sensor, wherein the second white light source is configured to direct white light into the well, and the second color sensor is optically communicative with the well.

[0168] Embodiment 10 is the sterilization indicator reading apparatus of any one of the preceding Embodiments, wherein the heater sleeve has a thermal conductivity of at least 100 W / (mK).

[0169] 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 heater sleeve and the well of the sterilization indicator reading apparatus, the biological indicator comprising: a transparent outer tube; a breaker element at least partially surrounding an ampoule and comprising a color indicator, wherein the ampoule comprises a fluorescently responsive substance; and a plurality of spores.

[0170] Embodiment 12 is the sterilization indicator system of Embodiment 11, wherein the biological indicator is in direct contact with the heating sleeve.

[0171] Embodiment 13 is the sterilization indicator system of any one of Embodiments 11 to 12, wherein the controller of the sterilization indicator reading apparatus increases the temperature of the heater sleeve when the biological indicator is below a preset temperature.

[0172] Embodiment 14 is the sterilization indicator system of any one of Embodiments 11 to 13, wherein the temperature of the heater sleeve increases at a rate of at least 100 degrees per minute.

[0173] Embodiment 15 is the sterilization indicator system of any one of Embodiments 11 to 14, wherein the controller of the sterilization indicator reading apparatus adjusts the temperature of the heater sleeve when the biological indicator is above a preset temperature.

[0174] Embodiment 16 is the sterilization indicator system of any one of Embodiments 11 to 15, wherein the temperature of the heater sleeve decreases at a rate of at least 30 degrees per minute.

[0175] Embodiment 17 is the sterilization indicator system of any one of Embodiments 11 to 16, wherein the transparent outer tube of the biological indicator transmits greater than 50% of visible light incident on the transparent outer tube.

[0176] Embodiment 18 is the sterilization indicator system of any one of Embodiments 11 to 17, wherein the first excitation source and the first color sensor of the sterilization indicator readingapparatus are optically communicative with the plurality of spores in fluid communication with a fluorescently responsive substance.

[0177] Embodiment 19 is the sterilization indicator system of any one of Embodiments 11 to 18, wherein a second white light source and a second color sensor are optically communicative with the color indicator.

[0178] Embodiment 20 is a method of using the sterilization indicator system of Embodiment 11, the method comprising: disposing the biological indicator at least partially within the heater sleeve and the well of the sterilization indicator reading apparatus; communicating a temperature of the biological indicator with the first thermal sensor disposed on the heater sleeve to the controller; activating the heater sleeve to a preset heating profile in response to a reading of the first thermal sensor to control the temperature of the heater sleeve; communicating the temperature of the biological indicator with the first thermal sensor disposed on the heater sleeve to the controller of the sterilization reading apparatus; and deactivating the heater sleeve.

[0179] Embodiment 21 is the method of Embodiment20, wherein the temperature of the heater sleeve increases at a rate of at least 100 degrees per minute.

[0180] Embodiment 22 is the method of Embodiment20, wherein the temperature of the heater sleeve decreases at a rate of at least 30 degrees per minute.

[0181] Embodiment 23 is the method of any one of Embodiments 20 to 22, the method further comprising activating a second white light source to reflect a color of the color indicator to the second color sensor of the sterilization indicator reading apparatus, communicating a reading of the color indicator from the second color sensor to the controller of the sterilization indicator reading apparatus, and activating a preset heating profile in response to the reading of the color indicator.

[0182] Embodiment 24 is the method of any one of Embodiments 20 to 23, wherein determining when the color of the color indicator is one of a plurality of preset colors indicators.

[0183] Embodiment 25 is the method of any one of Embodiments 20 to 24, wherein the color indicator is a brown color.

[0184] Embodiment 26 is the method of any one of Embodiments 20 to 25, wherein the color indicator is a blue color.

[0185] Embodiment 27 is the method of any one of Embodiments 20 to 26, wherein the color indicator is a pink color.

[0186] Embodiment 28 is the method of any one of Embodiments 20 to 27, wherein when the color is recognized by the second color sensor the controller activates a predetermined fluorescence reading.

[0187] Embodiment 29 is the method of any one of Embodiments 20 to 28, wherein determining whether the sterilization indicator reading apparatus indicates a successful sterilization cycle based on a fluorescence reading.

[0188] Embodiment 30 is the method of any one of Embodiments 20 to 29, wherein the fluorescence reading is a purple color.

Claims

CLAIMSWhat is claimed is:

1. 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 at least partially defined by a heater sleeve, the well and the heater sleeve oriented along a well axis extending from a well open end to a well bottom end, wherein the well is configured to receive at least a portion of a biological indicator; a heater element coupled to the heater sleeve; an insulating layer coupled to the heater sleeve and the heater element; a first thermal sensor disposed on the heater sleeve; and a first printed circuit board comprising: a first fluorescence excitation source and a first white light source configured to direct light into the well; a first color sensor configured to measure a fluorescence and detect a color in the well; and a controller circuit comprising a controller and a memory, wherein the controller is communicatively coupled with the heater sleeve, the heater element, and the first thermal sensor.

2. The sterilization indicator reading apparatus of claim 1, wherein the heater sleeve comprises a thickness from 750 micrometers to 1250 micrometers.

3. The sterilization indicator reading apparatus of any one of claims 1 or 2, wherein a plurality of wells are disposed within the housing.

4. The sterilization indicator reading apparatus of claim 3, wherein each of the plurality of wells within the housing comprises a heater sleeve.

5. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the heater element further comprises a second thermal sensor.

6. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the heater sleeve at least partially defines a circumference of the well.

7. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the heater sleeve is formed by a heat conductive material.

8. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the controller comprises logic to control a temperature of the heater sleeve.

9. The sterilization indicator reading apparatus of any one of the preceding claims, the first printed circuit board further comprises a second white light source and a second color sensor, wherein the second white light source is configured to direct white light into the well, and the second color sensor is optically communicative with the well.

10. The sterilization indicator reading apparatus of any one of the preceding claims, wherein the heater sleeve has athermal conductivity of at least 100 W / (mK).

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 heater sleeve and the well of the sterilization indicator reading apparatus, the biological indicator comprising: a transparent outer tube; a breaker element at least partially surrounding an ampoule and comprising a color indicator, wherein the ampoule comprises a fluorescently responsive substance; and a plurality of spores.

12. The sterilization indicator system of claim 11, wherein the biological indicator is in direct contact with the heating sleeve.

13. The sterilization indicator system of any one of claims 11 or 12, wherein the controller of the sterilization indicator reading apparatus increases the temperature of the heater sleeve when the biological indicator is below a preset temperature.

14. The sterilization indicator system of any one of claims 11 to 13, wherein the temperature of the heater sleeve increases at a rate of at least 100 degrees per minute.

15. The sterilization indicator system of any one of claims 11 to 14, wherein the controller of the sterilization indicator reading apparatus adjusts the temperature of the heater sleeve when the biological indicator is above a preset temperature.

16. The sterilization indicator system of any one of claims 11 to 15, wherein the temperature of the heater sleeve decreases at a rate of at least 30 degrees per minute.

17. The sterilization indicator system of any one of claims 11 to 16, wherein the transparent outer tube of the biological indicator transmits greater than 50% of visible light incident on the transparent outer tube.

18. The sterilization indicator system of any one of claims 11 to 17, 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.

19. The sterilization indicator system of any one of claims 11 to 18, wherein a second white light source and a second color sensor are optically communicative with the color indicator.

20. A method of using the sterilization indicator system of claim 11, the method comprising: disposing the biological indicator at least partially within the heater sleeve and the well of the sterilization indicator reading apparatus; communicating a temperature of the biological indicator with the first thermal sensor disposed on the heater sleeve to the controller; activating the heater sleeve to a preset heating profile in response to a reading of the first thermal sensor to control the temperature of the heater sleeve; communicating the temperature of the biological indicator with the first thermal sensor disposed on the heater sleeve to the controller of the sterilization reading apparatus; and deactivating the heater sleeve.

21. The method of claim 20, wherein the temperature of the heater sleeve increases at a rate of at least 100 degrees per minute.

22. The method of claim 20, wherein the temperature of the heater sleeve decreases at a rate of at least 30 degrees per minute.

23. The method of any one of claims 20 to 22, the method further comprising activating a second white light source to reflect a color of the color indicator to a second color sensor of the sterilization indicator reading apparatus, communicating a reading of the color indicator from the second color sensor to the controller of the sterilization indicator reading apparatus, and activating a preset heating profile in response to the reading of the color indicator.

24. The method of any one of claims 20 to 23, wherein determining when the color of the color indicator is one of a plurality of preset colors indicators.

25. The method of any one of claims 20 to 24, wherein the color indicator is a brown color.

26. The method of any one of claims 20 to 25, wherein the color indicator is a blue color.

27. The method of any one of claims 20 to 26, wherein the color indicator is a pink color.

28. The method of any one of claims 20 to 27, wherein when the color is recognized by a second color sensor the controller activates a predetermined fluorescence reading.

29. The method of any one of claims 20 to 28, wherein determining whether the sterilization indicator reading apparatus indicates a successful sterilization cycle based on a fluorescence reading.

30. The method of any one of claims 20 to 29, wherein the fluorescence reading is a purple color.

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