Process challenge device and disinfection system

Abstract

A process challenge device for determining the effectiveness of a disinfection procedure includes a pouch. The pouch includes an inner surface defining an interior storage space of the pouch, an outer surface opposite the inner surface, an inner film including polypropylene (PP), and an outer film including polyethylene terephthalate (PET). The outer membrane is disposed directly adjacent to and in contact with the inner membrane. The process challenge device also includes a test indicator received within the internal storage space of the pouch. The total thickness of the bag is equal to the sum of the thickness of the inner film and the thickness of the outer film. The total thickness is greater than or equal to 62 microns and less than or equal to 65 microns. The pouch has a water vapor transmission rate (WTVR) of greater than 0.5 g / m2 / 24 hours and less than 3 g / m2 / 24 hours.

Description

Technical Field

[0001] The present disclosure relates generally to a process challenge device and a sterilization system, and more particularly to a process challenge device for determining the effectiveness of a sterilization procedure. Background Art

[0002] Sterilization of medical and hospital equipment can be ineffective unless the steam sterilant contacts all surfaces of the material being sterilized under the appropriate combination of time, temperature, and steam quality. In steam sterilizers, such as pre-vacuum steam sterilizers and gravity displacement steam sterilizers, the sterilization process is performed in three main phases. In the first phase, air is removed, including air trapped in any porous materials being processed. Thus, the first phase is the air removal phase. The second phase is the sterilization phase, in which the load (i.e., the item being sterilized) is subjected to steam under pressure for a recognized, predetermined time and temperature combination to achieve sterilization. The third phase is the drying phase, in which condensation formed in the first two phases is removed by evacuating the chamber.

[0003] Any air not removed from the sterilizer during the air removal phase of the cycle, or any air that leaks into the sterilizer during the subatmospheric pressure phase due to, for example, a faulty gasket, valve, or seal, can form air pockets in any porous materials present. These air pockets can create a barrier to steam penetration, preventing adequate sterilization conditions from being achieved on all surfaces of the load during the sterilization phase. For example, these air pockets can prevent steam from reaching the inner layers of materials such as medical linens or fabrics. In other examples, these air pockets can prevent steam from penetrating hollow spaces within tubes, catheters, syringe needles, and the like. Furthermore, the presence of non-condensable gases (typically air) within the sterilizer is a poor sterilant and can reduce sterilization efficacy. The volume percentage of non-condensable gases in steam should be less than or equal to 3.5%. Therefore, the presence of air pockets and / or non-condensable gases can affect the steam quality of the steam sterilizer. Consequently, due to the reduced steam quality, proper sterilization may not be achieved. Several other factors that can affect steam quality include insufficient steam supply, water quality, degassing, and sterilizer chamber design.

[0004] It can be argued that proper sterilization may not occur due to inadequate steam quality, air removal, time, and sterilization temperature. To monitor whether the sterilization process is at an adequate temperature, with adequate steam quality and air removal, and for an adequate period of time, a process interrogation device and / or a Bowie-Dick test device are used. A process interrogation device can be used to assess steam parameters such as steam quality, temperature, and the duration of the sterilization process. A Bowie-Dick test device focuses more on monitoring air removal within the sterilization chamber. Summary of the Invention

[0005] In a first aspect, the present disclosure provides a process challenge device for determining the effectiveness of a sterilization procedure. The process challenge device includes a bag. The bag includes an inner surface defining an internal storage space of the bag and an outer surface opposite the inner surface. The bag also includes an inner film comprising at least 95% by weight polypropylene (PP). The inner film includes the inner surface. The bag also includes an outer film attached to the inner film and comprising at least 95% by weight polyethylene terephthalate (PET). The outer film is directly adjacent to and in contact with the inner film on the opposite side of the inner surface. The outer film includes the outer surface. The process challenge device includes a test indicator received in the internal storage space of the bag. The total thickness of the bag is equal to the sum of the thickness of the inner film and the thickness of the outer film. The total thickness is greater than or equal to 62 microns and less than or equal to 65 microns. The bag has a viscosity greater than 0.5 g / m 2 / 24 hours and less than 3g / m 2 / 24-hour water vapor transmission rate (WTVR).

[0006] In a second aspect, the present disclosure provides a sterilization system. The sterilization system includes a steam sterilizer comprising a sterilization chamber configured to receive a steam sterilant therein. The sterilization system includes a process query device removably received within the sterilization chamber and configured to determine the effectiveness of a sterilization procedure. The process query device includes a bag. The bag includes an inner surface defining an internal storage space of the bag and an outer surface opposite the inner surface. The bag also includes an inner film comprising at least 95% by weight polypropylene (PP). The inner film includes the inner surface. The bag also includes an outer film attached to the inner film and comprising at least 95% by weight polyethylene terephthalate (PET). The outer film is directly adjacent to and in contact with the inner film on an opposite side of the inner surface. The outer film includes the outer surface. The process query device also includes a test indicator received within the internal storage space of the bag. The total thickness of the bag is equal to the sum of the thickness of the inner film and the thickness of the outer film, and the total thickness is greater than or equal to 62 microns and less than or equal to 65 microns. 2 / 24 hours and less than 3g / m 2 / 24-hour water vapor transmission rate (WTVR). BRIEF DESCRIPTION OF THE DRAWINGS

[0007] A more complete understanding of the exemplary embodiments disclosed herein may be obtained by considering the following detailed description in conjunction with the following drawings. The drawings are not necessarily drawn to scale. Like numbers used in the drawings refer to like components. However, it should be understood that the use of a number to refer to a component in a given figure is not intended to limit the component labeled with the same number in another figure.

[0008] Figure 1 is a schematic block diagram of a disinfection system according to an embodiment of the present disclosure;

[0009] Figure 2 is a schematic top view of a process challenge device of a disinfection system according to an embodiment of the present disclosure;

[0010] Figure 3 According to the embodiment of the present disclosure, Figure 2 A cross-sectional side view of the process challenge device taken along line AA' is shown; and

[0011] Figure 4 According to one embodiment of the present disclosure Figure 3 Schematic enlarged view of section X of the bag of the process interrogation device. DETAILED DESCRIPTION

[0012] In the following description, reference is made to the accompanying drawings, which form a part thereof, and in which various embodiments are shown by way of illustration. It should be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. Therefore, the following detailed description should not be construed in a limiting sense.

[0013] As used herein, all numbers should be considered to be modified by the term “about.” As used herein, “a,” “an,” “the,” “at least one,” and “one or more” are used interchangeably.

[0014] Unless specifically defined otherwise, the term "about" means a close approximation (eg, within + / - 5% for a quantifiable property), but again does not require absolute precision or a perfect match.

[0015] As used herein as a modifier of a characteristic or property, unless otherwise specifically defined, the term "generally" means that the characteristic or property would be readily discernible by one of ordinary skill but does not require absolute precision or a perfect match (e.g., within + / - 20% for a quantifiable property).

[0016] Unless specifically defined otherwise, the term "substantially" means a high degree of approximation (eg, within + / - 10% for a quantifiable characteristic), but again does not require absolute precision or a perfect match.

[0017] Terms such as identical, equal, consistent, constant, exact, etc. are to be understood as within the usual tolerances or measurement errors applicable to the particular situation, without requiring absolute precision or a perfect match.

[0018] As used herein, the terms "first" and "second" are used as identifiers. Therefore, such terms should not be interpreted as limiting the present disclosure. The terms "first" and "second" can be interchangeable in embodiments of the present disclosure when used in conjunction with features or elements.

[0019] As used herein, “at least one of A and B” should be understood to mean “only A, only B, or both A and B”.

[0020] As used herein, the term "configured to" and the like are at least as restrictive as the term "adapted to" and require actual design intent to perform the specified function, not merely the physical ability to perform such function.

[0021] As used herein, the terms "layer," "sheet," and "film," or variations thereof, are used to describe an article having a small thickness relative to its length and width.

[0022] Steam sterilizers are widely used in medical centers and hospitals to sterilize medical equipment. Frequent testing or monitoring of steam quality can be crucial to ensuring the safe use of medical equipment in medical treatments. In other words, before subjecting the steam to a given load (i.e., medical equipment), periodic tests may be necessary to check the effectiveness of air removal during the air removal phase of the sterilization process. One method for monitoring the steam quality of steam sterilizers is to use a process interrogation device.

[0023] A steam flush pressure pulse (SFPP) sterilizer is a type of sterilizer that uses a series of steam flushes and pressure pulses to remove air from the sterilization chamber and / or medical devices during the preconditioning phase and prior to exposure. SFPP sterilizers are used to sterilize medical devices with components or surfaces with lumens that inhibit steam from contacting all surfaces. SFPP sterilizers use an extended cycle with multiple pulses during the preconditioning phase to remove air from difficult-to-sterilize surfaces, such as lumens in medical devices.

[0024] Typically, a process challenge device containing the medical device to be sterilized and an indicator is placed within the sterilization chamber of an SFPP sterilizer to monitor effective sterilization. The indicator monitors a defined resistance to steam during the sterilization process. The indicator can be used to evaluate the performance of a defined sterilization process. To effectively sterilize medical devices, the process challenge device should simulate the resistance / resistance presented by the medical device used during the sterilization process. The process challenge device provides a repeatable challenge of the sterilization process by representing the worst-case steam conditions that will be experienced within the sterilization chamber. While such process challenge devices have been useful, they are not always convenient for use within extended cycles with longer steam exposures.

[0025] The present disclosure relates to a process challenge device for determining the effectiveness of a sterilization procedure. The process challenge device includes a bag. The bag includes an inner surface defining an internal storage space of the bag and an outer surface opposite the inner surface. The bag also includes an inner film, the inner film including at least 95% by weight of polypropylene (PP). The inner film includes the inner surface. The bag also includes an outer film attached to the inner film and including at least 95% by weight of polyethylene terephthalate (PET). The outer film is directly adjacent to and in contact with the inner film on the opposite side of the inner surface. The outer film includes the outer surface. The process challenge device includes a test indicator received in the internal storage space of the bag. The total thickness of the bag is equal to the sum of the thickness of the inner film and the thickness of the outer film. The total thickness is greater than or equal to 62 microns and less than or equal to 65 microns. The bag has a viscosity greater than 0.5 g / m 2 / 24 hours and less than 3g / m 2 / 24-hour water vapor transmission rate (WTVR).

[0026] The disclosed process challenge device is a bag of dual-film construction, comprising a polypropylene inner film and a polyethylene terephthalate outer film. The disclosed overall thickness and WTVR of the bag provide the desired resistance to steam sterilizers and can therefore help determine the effectiveness of a sterilization procedure. To effectively sterilize medical devices, the disclosed process challenge device is capable of simulating the challenge / resistance presented by medical devices used during sterilization. Thus, the polypropylene inner film and polyethylene terephthalate outer film can represent worst-case conditions for steam sterilizers within a sterilization chamber.

[0027] In some embodiments, the process interrogation device of the present disclosure can monitor extended cycles of a steam flush pressure pulse (SFPP) sterilizer. It should be noted that the process interrogation device can be used to monitor extended cycles with longer steam exposures. Furthermore, compared to conventional process interrogation devices, the process interrogation device of the present disclosure can provide relatively greater resistance to steam sterilants, with a longer disinfect time, enabling test indicators to withstand a long preconditioning phase before exposure to sterilization. Therefore, the process interrogation device of the present disclosure can facilitate the development of more resistant biological or chemical indicator devices that are exposed to longer periods of steam within a sterilization chamber.

[0028] Now refer to the figure, Figure 11 is a schematic block diagram of a sterilization system 100 according to one embodiment of the present disclosure. The sterilization system 100 includes a steam sterilizer 102, which includes a sterilization chamber 104 configured to receive a steam sterilant therein. The sterilization chamber 104 may have one or more environmental conditions. In some cases, the environmental conditions may be related to the conditions inside the sterilization chamber 104 and may include time, sterilant, temperature, pressure, or a combination thereof. In some embodiments, the sterilization chamber 104 may be made of various materials, such as, but not limited to, steel, metal, polymer, or any other material. When steam is used as the steam sterilant, the goal of the sterilization process is to bring the steam into contact with all surfaces of the article being sterilized at an appropriate temperature and for an appropriate period of time.

[0029] The sterilization system 100 includes a process challenge device 106 that is removably received within the sterilization chamber 104 and configured to determine the effectiveness of a sterilization procedure. The process challenge device 106 can be configured to perform a Bowie-Dick test and provide resistance to a steam sterilant. In some embodiments, the process challenge device 106 can be adapted to determine the effectiveness of a sterilization procedure selected from the group consisting of: a 121°C gravity process, a 121°C pre-vacuum process, a 121°C SFPP process, a 132°C gravity process, a 132°C pre-vacuum process, a 132°C SFPP process, a 134°C pre-vacuum process, a 134°C SFPP process, a 135°C gravity process, a 135°C pre-vacuum process, and a 135°C SFPP process. SFPP refers to a steam purge pressure pulse sterilization cycle, and pre-vacuum refers to a pre-vacuum or vacuum-assisted sterilization cycle.

[0030] The process interrogation device 106 includes a test indicator 107. In some embodiments, the test indicator 107 can be a biological indicator (BI) or a chemical indicator (CI). Biological indicators can include viable microorganisms with a defined resistance to the sterilization process and can indicate the effectiveness of the sterilization procedure. Chemical indicators can include one or more chemicals that can visually change their color to indicate the effectiveness of the sterilization procedure. The test indicator 107 can be selected for use with the sterilization conditions employed in a particular sterilization process. Furthermore, the test indicator 107 can be selected based on the amount of exposure to the sterilization condition required for the test indicator 107 to indicate that exposure has occurred. Thus, the selection of the test indicator 107 can be used to increase or decrease the resistance of the process interrogation device 106.

[0031] In some other embodiments, the process challenge device 106 may include, but is not limited to, any type of consumer or industrial product, medical product, pharmaceutical product, or food product that is sterilized within the sterilization chamber 104 .

[0032] Figure 2is a schematic top view of a process challenge device 106 according to one embodiment of the present disclosure. The process challenge device 106 includes a bag 108. Figure 3 According to one embodiment of the present disclosure, Figure 2 A cross-sectional side view of the process challenge device 106 is shown taken along line AA'.

[0033] refer to Figure 2 and Figure 3 , the bag 108 includes an inner surface 110 that defines an interior storage space 112 of the bag 108. The test indicator 107 is received within the interior storage space 112 of the bag 108. In some embodiments, two or more test indicators 107 can be received within the interior storage space 112 of the bag 108. The bag 108 also includes an outer surface 113 opposite the inner surface 110. In some embodiments, the bag 108 does not have any through-holes extending from the inner surface 110 to the outer surface 113.

[0034] In some embodiments, the bag 108 further includes a perimeter seal 114 that seals the interior storage space 112 of the bag 108. In some embodiments, the perimeter seal 114 is a heat seal. In some embodiments, the perimeter seal 114 may be an ultrasonic seal. In other embodiments, the interior storage space 112 of the bag 108 may be sealed with an adhesive, including a pressure-sensitive adhesive. In some cases, the bag 108 may include a flexible sheet that can be folded so that one or more side walls of the flexible sheet overlap, thereby creating the interior storage space 112 of the bag 108. The perimeter seal 114 may connect the overlapping side walls of the bag 108.

[0035] Bag 108 also includes an inner film 116 comprising at least 95% by weight polypropylene (PP). Inner film 116 includes inner surface 110. In some embodiments, inner film 116 comprises at least 99% by weight polypropylene. In some examples, the polypropylene can be cast polypropylene (CPP), oriented polypropylene (OPP), or any combination thereof. In some other examples, inner film 116 can also comprise nylon.

[0036] The bag 108 also includes an outer film 118 attached to the inner film 116 and comprising at least 95% by weight polyethylene terephthalate (PET). In some embodiments, the outer film 118 comprises at least 99% by weight polyethylene terephthalate. Polyethylene terephthalate is a polyester that refers to a homopolymer or copolymer having ester bonds between monomer units, or a homopolymer or copolymer of an alkyl aromatic ester, including but not limited to amorphous polyethylene terephthalate (APET), polyethylene furanoate (PEF), glycol-modified polyethylene terephthalate (PETG) and polybutylene terephthalate (PBT); or a copolymer of terephthalate and isophthalate, including but not limited to polyethylene terephthalate / isophthalate copolymers, such as isophthalic acid (IPA) (modified polyethylene terephthalate (PETI)). The outer film 118 is disposed directly adjacent to and in contact with the inner film 116 on the opposite side of the inner surface 110 . Specifically, the outer film 118 includes an outer surface 113 .

[0037] Figure 4 is a cross-section X (at Figure 3 ). Figures 2 to 4 , the bag 108 has a total thickness T3 that is equal to the sum of the thickness T1 of the inner film 116 and the thickness T2 of the outer film 118. In some embodiments, the thickness T1 of the inner film 116 is equal to the thickness T2 of the outer film 118. In some other embodiments, the thickness T1 of the inner film 116 is different from the thickness T2 of the outer film 118. The total thickness T3 is greater than or equal to 62 microns and less than or equal to 65 microns.

[0038] refer to Figures 1 to 4 , bag 108 has a value greater than 0.5 g / m 2 / 24 hours and less than 3g / m 2 / 24 hours water vapor transmission rate (WTVR) or moisture vapor transmission rate (MVTR). In some embodiments, the WVTR / MVTR of the bag 108 is 0.96 g / m 2 / 24 hours. MVTR is the mass (in grams) of steam sterilant that passes through a given area (in square meters) of the bag 108 at a specific temperature and humidity within a given time period. In other words, MVTR is the amount of steam sterilant that passes through the bag 108 as steam enters the interior of the sterilization chamber 104 during the sterilization process. WVTR is hereinafter interchangeably referred to as MVTR.

[0039] The process challenge device 106 is formed into a dual-film construction in the form of a bag 108, including a polypropylene inner film 116 and a polyethylene terephthalate outer film 118. The disclosed total thickness T3 and WTVR of the bag 108 can provide the desired resistance to steam sterilizers and can therefore help determine the effectiveness of the sterilization procedure. In order to effectively sterilize medical devices, the process challenge device 106 can simulate the challenge / resistance presented by medical devices used during the sterilization process. Therefore, the polypropylene inner film 116 and the polyethylene terephthalate outer film 118 can represent the worst-case conditions for steam sterilizers within the sterilization chamber 104.

[0040] In some embodiments, the process interrogation device 106 can monitor extended cycles of a steam flush pressure pulse (SFPP) sterilizer. It should be noted that the process interrogation device 106 can be used to monitor extended cycles with longer steam exposures. Furthermore, compared to conventional process interrogation devices, the process interrogation device 106 of the present disclosure can provide relatively greater resistance to steam sterilants, with a longer disinfect time, enabling the test indicator 107 to withstand a long preconditioning phase before exposure to sterilization. Thus, the process interrogation device 106 can facilitate the development of more resistant biological or chemical indicator devices that are exposed to longer periods of steam within the sterilization chamber 104. MVTR measurement method

[0041] MVTR can be measured using a modified Payne cup method. A sample with a diameter of 1.5 inches is cut using a circular die cutter, ensuring that the sample is large enough to completely cover the oval hole of the two adhesive foil rings. The backing is removed from the two adhesive foil rings and the sample is placed between the adhesive-containing surfaces of the two foil adhesive rings. The oval holes of each adhesive foil ring are carefully aligned with each other. Finger pressure is used to form a foil assembly that is flat, wrinkle-free, and has no void areas in the exposed sample area (i.e., the sample assembly is placed between the adhesive foil rings).

[0042] Use a plastic beaker to fill a 4oz glass bottle with approximately 50mL of water. Place the rubber gasket on the bottle mouth and place the foil assembly on the rubber gasket in the center of the bottle. Then loosely screw the bottle cap onto the bottle.

[0043] Place the bottles upright in a wire basket. Place the wire basket with the bottles in sterilization chamber 104 at 40°C and 20% relative humidity for 4 to 6 hours. At the end of the 6 hours (bottle conditioning), tighten the bottle caps in sterilization chamber 104 so that the specimens are flush with the caps (no bulging) and the rubber gaskets are in place.

[0044] Remove the wire basket from the sterilization chamber 104 and immediately weigh the bottle to the nearest 0.01 g to obtain the initial weight W1 (see Formula 1). The bottle is then placed upright in the wire basket and returned to the sterilization chamber 104 for 18 to 24 hours. Record the date and time (in hours) when the bottle is placed in the sterilization chamber 104. After time h1, remove the basket and immediately weigh the bottle to the nearest 0.01 g to obtain the final weight W2. Record the date and time (in hours) when the bottle is removed from the sterilization chamber 104.

[0045] Calculate in g / m according to the formula 1 provided below 2 / 24 hours moisture vapor transmission rate (MVTR) of the sample: MVTR (g / m 2 / 24 hours) = ((W1 - W2) * 24) / (A * T) (Formula 1) Where W1 is the initial weight of the bottle in grams; W2 is the final weight of the bottle in grams; 24 is MVTR normalized to 24 hours; A is the exposed area of the sample in square meters; and T is the time, in hours, that the sample spends in the sterilization chamber 104, ie, h2 - h1. test Test 1

[0046] Tests were performed to determine the MVTR of three different bags having different thicknesses. The three different bags included bag 108 (e.g., Figure 2 As shown, the bag 108 comprises a plurality of bags (e.g., bag A, bag B, and bag B). Specifically, bag 108 is composed of PP and PET and has a thickness of 62 to 65 microns. Bag A is composed of metalized PET and has a thickness of 84 to 89 microns. Bag B is composed of foil (made of metal) and has a thickness of 108 to 112 microns. Furthermore, each of bag 108, bag A, and bag B carries 1.5 kg of surgical instruments.

[0047] In this test, each of bag 108, bag A, and bag B was placed in sterilization chamber 104 ( Figure 1 The temperature in the sterilization chamber 104 of the steam sterilizer 102 is maintained at approximately 132°C.

[0048] For each of bag 108, bag A, and bag B, the average MVTR is expressed in grams per square meter per 24 hours (g / m 2 The average MVTR measurements are summarized in Table 1 provided below.

[0049] The data in Table 1 show that when the bag 108 was sterilized in the sterilization chamber 104, the average MVTR recorded was 0.96 g / m 2 In addition, when bag A was sterilized in sterilization chamber 104, the average MVTR recorded was 0.012 g / m 2 / 24 hours. The data shows that as the thickness of bag A increases (relative to the thickness of bag 108), the average MVTR of bag A decreases. Specifically, the average MVTR of bag 108 is almost 8 times more effective than that of bag A. In addition, when bag B was sterilized in sterilization chamber 104, an average MVTR of 0.0004 g / m was recorded. 2 / 24 hours. Therefore, the thickness of bags A and B negatively impacts the average MVTR of the respective bags. Since bag 108 has the highest average MVTR, the surgical instruments loaded within bag 108 are properly sterilized. Therefore, the process interrogation device 106 of bag 108 can accurately determine the effectiveness of the sterilization process. Test 2

[0050] Tests were performed to determine the performance of biological indicators contained within three different bags. The three different bags included bag 108 (e.g., Figure 2 ), bag A, and bag B. In addition, each of bag 108, bag A, and bag B carries 1.5 kg of surgical instruments. In addition, during testing, test indicator 107 can be a biological indicator received within each of bag 108, bag A, and bag B.

[0051] In this test, each of bag 108, bag A, and bag B was placed in sterilization chamber 104 ( Figure 1 ) and undergo a sterilization process. The temperature within sterilization chamber 104 of steam sterilizer 102 was maintained at approximately 132°C. Furthermore, the biological indicators contained within each of bags 108, bag A, and bag B were incubated for 0 minutes and 6 minutes. A test was performed on the biological indicators within each of bags 108, bag A, and bag B to identify fluorescence indicating complete inactivation of the test microorganisms or survival / growth of at least a portion of the test microorganisms after exposure to the sterilization process.

[0052] The performance of each biological indicator received within the corresponding bag at 0 minutes and 6 minutes is summarized in Table 2 provided below.

[0053] The data in Table 2 shows that bag 108 passed the biological indicator survival test at 0 minutes of exposure and passed complete kill after 6 minutes of exposure to the steam sterilization cycle. Complete kill means that the exposure time (i.e., 6 minutes) was sufficient to inactivate the viable microorganisms of the biological indicator. Bag A passed the biological indicator survival test at 0 minutes of exposure, but failed to achieve complete kill after 6 minutes of exposure to the steam sterilization cycle. Bag B passed the biological indicator survival test at 0 minutes of exposure and failed to achieve complete kill after 6 minutes of exposure to the steam sterilization cycle.

[0054] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.

[0055] Although specific embodiments have been illustrated and described herein, it should be understood by those skilled in the art that various alternative and / or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptation or variation of the specific embodiments discussed herein. Therefore, the present disclosure is intended to be limited only by the claims and their equivalents.

Claims

1. A process challenge device for determining the effectiveness of a sterilization procedure, the process challenge device comprising: A bag comprising: an interior surface defining an interior storage space of the bag; an outer surface opposite to the inner surface; an inner film comprising at least 95 wt.% polypropylene (PP), said inner film comprising said inner surface; and an outer film attached to the inner film and comprising at least 95% by weight polyethylene terephthalate (PET), wherein the outer film is positioned directly adjacent to and in contact with the inner film on an opposite side of the inner surface, the outer film comprising the outer surface; and a test indicator received within the interior storage space of the bag; in: The total thickness of the bag is equal to the sum of the thickness of the inner film and the thickness of the outer film, the total thickness being greater than or equal to 62 microns and less than or equal to 65 microns; and The bag has a thickness greater than 0.5 g / m 2 / 24 hours and less than 3g / m 2 / 24-hour water vapor transmission rate (WTVR).

2. The process challenge device of claim 1, wherein the bag is free of any through-holes extending from the inner surface to the outer surface.

3. The process challenge device of claim 1, wherein the bag further comprises a perimeter seal such that the interior storage space of the bag is sealed. The process challenge device of claim 3 , wherein the perimeter seal is a heat seal.

5. The process challenge device of claim 1 , wherein the WVTR of the bag is 0.96 g / m 2 / 24 hours. The process challenge device of claim 1 , wherein the test indicator is a biological indicator or a chemical indicator.

7. The process challenge device of claim 1 , wherein the inner film comprises at least 99% by weight polypropylene.

8. The process challenge device of claim 1, wherein the outer film comprises at least 99% by weight polyethylene terephthalate.

9. The process challenge device of claim 1, wherein a thickness of the inner membrane is equal to a thickness of the outer membrane.

10. The process interrogation device of claim 1, wherein the thickness of the inner membrane is different from the thickness of the outer membrane.

11. A disinfection system, comprising: a steam sterilizer comprising a sterilization chamber configured to receive a steam sterilant therein; and a process challenge device removably received within the sterilization chamber and configured to determine the effectiveness of the sterilization procedure, the process challenge device comprising: A bag comprising: an interior surface defining an interior storage space of the bag; an outer surface opposite to the inner surface; an inner film comprising at least 95 wt.% polypropylene (PP), said inner film comprising said inner surface; and an outer film attached to the inner film and comprising at least 95% by weight polyethylene terephthalate (PET), wherein the outer film is positioned directly adjacent to and in contact with the inner film on an opposite side of the inner surface, the outer film comprising the outer surface; and a test indicator received within the interior storage space of the bag; in: The total thickness of the bag is equal to the sum of the thickness of the inner film and the thickness of the outer film, the total thickness being greater than or equal to 62 microns and less than or equal to 65 microns; and The bag has a thickness greater than 0.5 g / m 2 / 24 hours and less than 3g / m 2 / 24-hour water vapor transmission rate (WTVR).

12. The disinfection system of claim 11, wherein the bag is free of any through-holes extending from the inner surface to the outer surface.

13. The disinfection system of claim 11, wherein the bag further comprises a perimeter seal such that the interior storage space of the bag is sealed.

14. The disinfection system of claim 13, wherein the perimeter seal is a heat seal.

15. The disinfection system of claim 11, wherein the bag has a WVTR of 0.96 g / m 2 / 24 hours.

16. The disinfection system of claim 11, wherein the test indicator is a biological indicator or a chemical indicator.

17. The disinfection system of claim 11, wherein the inner film comprises at least 99% by weight polypropylene.

18. The disinfection system of claim 11, wherein the outer film comprises at least 99% by weight polyethylene terephthalate.

19. The disinfection system of claim 11, wherein the thickness of the inner film is equal to the thickness of the outer film.

20. The disinfection system of claim 11, wherein the thickness of the inner film is different from the thickness of the outer film.

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