Sterilization Chemistry Indicators

Abstract

The present disclosure relates generally to chemical indicators. Specifically, the chemical indicators are useful for monitoring sterilization processes. The chemical indicators include a fluid pathway and a chamber containing a chemical indicator composition.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to chemical indicators for monitoring sterilization processes. [Background technology]

[0002] Medical instruments, particularly surgical instruments, are typically sterilized using steam or other sterilizing gases or liquids before use. A commonly used sterilization process is exposure of the instruments to steam under pressure. Alternative sterilization processes use gases such as ethylene oxide and hydrogen peroxide as sterilants. The use of hydrogen peroxide and other chemical vapor sterilization techniques typically involves operating temperatures much lower than those associated with steam sterilization and is therefore suitable for temperature-sensitive devices, such as those containing plastics.

[0003] Sterilization indicators are used to monitor whether a sterilization process has been performed and / or whether critical sterilization parameters have been met. Sterilization indicators typically include a chemical indicator composition carried on a substrate that changes color during the sterilization process. Sterilization process indicators indicate whether monitored instruments and devices have been exposed to a sterilant, regardless of exposure time. Sterilization integrators, on the other hand, indicate whether monitored instruments and devices have been exposed to a sterilant sufficiently to meet two or more of the critical parameters for sterilization (typically sterilant exposure time, sterilant concentration, and sterilant temperature).

[0004] For gaseous sterilants other than vapor, such as hydrogen peroxide and ethylene oxide, indicator design is challenging due to the tendency of these gases to permeate and then slowly diffuse out of the indicator material and the material of the medical device being sterilized. Sterilant isolation and subsequent slow outgassing can continue to cause the indicator to discolor even after the sterilization process is complete. In the case of hydrogen peroxide sterilization indicator design, an additional factor of concern is the high oxidizing power of hydrogen peroxide, which can cause the indicator color to change too rapidly to be useful for monitoring critical sterilization parameters required by sterilization integrators. Furthermore, as surgical instruments and medical devices become more complex, there continues to be a need to monitor the sterilization of luminal instruments and hard-to-reach surfaces on complex devices. The present disclosure provides solutions to these problems and needs that have been recognized by researchers in the sterilization monitoring field. Summary of the Invention

[0005] FIELD OF THE DISCLOSURE Generally, the present disclosure relates to chemical indicators. More specifically, the present disclosure relates to chemical indicators useful for monitoring a sterilization process. The chemical indicator includes a fluid pathway and a chamber containing a chemical indicator composition.

[0006] In one embodiment, the chemical indicator of the present disclosure comprises: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a fluid path; a chamber; the fluid path includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of the fluid pathway defined by a first sheet, a top of the fluid pathway defined by a second sheet, and sides of the fluid pathway defined by a third sheet, the fluid pathway having a first end defining a first opening and a second end defining a second opening; A first end of the fluid pathway is configured to be in fluid communication with the ambient environment, and a second end of the fluid pathway is configured to be in fluid communication with the chamber.

[0007] See FIG. 1 for a schematic diagram of certain aspects of the above embodiment.

[0008] In some embodiments, the first sheet and the second sheet are substantially impermeable to the sterilant.

[0009] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are intended to facilitate understanding of certain terms used frequently in this application and are not intended to preclude reasonable interpretations of such terms in the context of this disclosure.

[0010] Unless otherwise indicated, all numbers in the description and claims expressing feature sizes, quantities, and physical properties used in the specification and claims should be understood to be modified in all instances by the term "about." Accordingly, unless specifically indicated to the contrary, the numerical parameters set forth in the above specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by one of ordinary skill in the art using the teachings disclosed herein. At the very least, each numerical parameter should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques; however, this is not intended to limit the application of the doctrine of equivalents to the scope of the claims. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0011] The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., a range of 1 to 5 includes, for example, 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within that range.

[0012] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include embodiments having plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0013] As used herein, the term "substantially impermeable" refers to the relative impermeability of a sterilant gas to penetrate the sheet of a chemical indicator. The goal of using a substantially impermeable material is to prevent the transport of a sterilant, such as hydrogen peroxide, through the material so that the sterilant is transported only through the openings and corresponding channels to the chemical indicator composition. In some embodiments, the material allows less than 5% of the sterilant flowing through the openings during a sterilization cycle to be transported through the sheet. In other embodiments, the material allows less than 1%, or less than 0.5%, or less than 0.1% of the sterilant flowing through the openings during a sterilization cycle to be transported through the sheet. Indicators of the present disclosure that include substantially impermeable first and second sheets allow the sterilant gas to travel along the fluid path and contact the chemical indicator composition, but prevent the sterilant gas from contacting the chemical indicator composition by traversing the first and second sheets. Thus, the substantial impermeability of a sheet of the present disclosure can be tested by blocking the flow of sterilizing gas into the fluid pathway opening of an indicator of the present disclosure, and if the color of the indicator changes upon exposure of such altered indicator to sterilizing gas after the sterilization cycle is completed, the sheet is not considered to be substantially impermeable for purposes of the present disclosure.

[0014] The term "directly adjacent" refers to the relative position of two elements, e.g., two sheets or layers that are adjacent to and in contact with each other, with no intermediate sheet or layer separating them. However, the term "directly adjacent" also encompasses situations where one or both elements (e.g., sheets) have been treated with a primer or have their surfaces otherwise modified to affect their properties, for example, by etching, embossing, etc., or by undergoing a surface treatment that may improve adhesion, such as corona or plasma treatment.

[0015] The term "substantially center" refers to a position located within two points A and B (e.g., the end openings of a fluid pathway) that is within 10% in distance in any direction from the geometric midpoint between the two points A and B.

[0016] The term "substantially circular" refers to the shape of element A that can be circumscribed within a donut-shaped area obtained by subtracting the area of ​​circle X from the area of ​​circle Y. Circle X has an area that is 10% smaller than the area of ​​element A, and circle Y has an area that is 10% larger than the area of ​​element A. Circles X and Y are assumed to be concentric in this definition.

[0017] The term "substantially along the entire length" of an element (e.g., a fluid path) refers to a length that is within 10% of the entire length of the element. For example, a chamber that extends substantially along the entire length of a fluid path refers to a chamber whose length is within 10% of the entire length of the fluid path.

[0018] The term "modulate" or "modulates," in the context of transport of a sterilant in a fluid pathway (by flow, diffusion, etc.), refers to the ability to reduce the transport of the sterilant in the fluid pathway in terms of reducing the mass of sterilant moving along the pathway or slowing the transport rate of the sterilant. [Brief explanation of the drawings]

[0019] [Figure 1]1 is an exploded cross-sectional view of one embodiment of a chemical indicator of the present disclosure. [Figure 2] FIG. 1 is a top view of one embodiment of a chemical indicator of the present disclosure. [Figure 3] FIG. 1 is a top view of one embodiment of a chemical indicator of the present disclosure. [Figure 4] FIG. 1 is a top view of one embodiment of a chemical indicator of the present disclosure. [Figure 5] FIG. 1 is a top view of one embodiment of a chemical indicator of the present disclosure. [Figure 6] FIG. 1 is a top view of one embodiment of a chemical indicator of the present disclosure. [Figure 7] 1 is a cross-sectional view of one embodiment of a chemical indicator of the present disclosure. [Figure 8] 1 is a cross-sectional view of one embodiment of a chemical indicator of the present disclosure. [Figure 9] FIG. 1 is a perspective view of a process challenge device including a chemical indicator of the present disclosure. [Figure 10] 1 is a plot showing the extent to which a chemical indicator of the present disclosure changes color under given hydrogen peroxide sterilization conditions. The beginning of the measured distance ("0.0 inches") corresponds to one open end of the indicator. The end of the measured distance ("2.0 inches") corresponds to the other open end of the indicator. [Figure 11] 1 is a plot showing the extent to which another chemical indicator of the present disclosure changes color under given hydrogen peroxide sterilization conditions. The beginning of the measured distance ("0.0 inches") corresponds to one closed end of the indicator. [Figure 12] 1 is a plot showing the extent to which another chemical indicator of the present disclosure changes color under given hydrogen peroxide sterilization conditions. The beginning of the measured distance ("0.0 inches") corresponds to one open end of the indicator. The end of the measured distance ("4.0 inches") corresponds to the other open end of the indicator. [Figure 13] 1 is a plot showing the extent to which another chemical indicator of the present disclosure changes color under given hydrogen peroxide sterilization conditions. The beginning of the measured distance ("0.0 inches") corresponds to one closed end of the indicator. [Figure 14] 1 is a plot showing the extent to which other chemical indicators of the present disclosure changed color under given hydrogen peroxide sterilization conditions. The beginning of the measured distance ("0.0 inches") corresponds to one closed end of each of the indicators. The end of the measured distance ("2.0 inches") corresponds to the closed ends of two indicators and the open ends on the other two indicators.

[0020] In the following description, reference is made to the accompanying drawings described herein. In some instances, the drawings may show, by way of illustration, several specific embodiments of the present disclosure. It is to be understood that other embodiments different from those explicitly shown in the drawings are contemplated and may be made without departing from the scope or spirit of the present disclosure. The following detailed description, therefore, is not to be construed in a limiting sense. DETAILED DESCRIPTION OF THE INVENTION

[0021] Referring now to the drawings, FIG. 1 is an exploded cross-sectional view of one embodiment of a chemical indicator 10 of the present disclosure. Chemical indicator 10 comprises a first sheet 11, a second sheet 12, a third sheet 13, and a fluid pathway 14. While FIG. 1 is an exploded view, one skilled in the art will understand that in one embodiment of a chemical indicator of the present disclosure based on FIG. 1, the first sheet is adjacent to or directly adjacent to the third sheet, and the third sheet is adjacent to or directly adjacent to the second sheet. The first and second sheets define the bottom and top of the fluid pathway. In the embodiment shown, the third sheet includes or is itself a notch or groove created by placing the two sheets proximate to one another. As shown in FIG. 1, the third sheet forms a sidewall of the fluid pathway. Thus, in one embodiment, the fluid pathway is formed by the combination of the first, second, and third sheets. Fluid pathway 14 provides a conduit through which a sterilizing gas, such as hydrogen peroxide, steam, or ethylene oxide, travels during a sterilization cycle to the chamber containing the chemical indicator composition.

[0022] FIG. 2 is a top view of one embodiment of a chemical indicator of the present disclosure. In this illustration, the top sheet (closer to the viewer) is assumed to be transparent so that the sheets can be seen. In this illustration, the indicator dots are on either the first sheet or the second sheet. As shown in FIG. 2, a chemical indicator 210 of the present disclosure has a first end 221 with a first opening 222 in fluid communication with the surroundings and a second end 223 with a second opening 224 in fluid communication with a chamber 225 containing a chemical indicator composition 226. The first opening 222 and the second opening 224 each have a height H and a width W. The height H of the two openings 222 and 224 is the vertical distance across the opening between the first and second sheets, and the width W of the two openings 222 and 224 is the vertical distance across the opening between the sidewalls of the opening formed by a groove or notch in a third sheet. During use, sterilant gas enters first opening 222 and then diffuses along fluid path 214 and through second opening 224 into chamber 225 where it reacts with chemical indicator composition 226 .

[0023] 3 is a top view of one embodiment of a chemical indicator 310 of the present disclosure. As shown in FIG. 3, the chemical indicator 310 of the present disclosure has a first opening 322 in fluid communication with the surroundings and a chamber 325, a second opening 324 in fluid communication with the surroundings, and the same chamber 325 in fluid communication with the first opening 322. The first opening 322 and the second opening 324 each have a height H and a width W. The height H of the two openings 322 and 324 is the vertical distance across the opening between the first and second sheets, and the width W of the two openings 322 and 324 is the vertical distance across the opening between the sidewalls of the opening formed by a groove or notch in the third sheet. The chamber contains a chemical indicator composition 326. During use, the sterilant gas enters the first opening 322 and the second opening 324 and then diffuses along the fluid path 314 to the chemical indicator composition 326 contained on or within the chamber 325, where it reacts with the chemical indicator composition 326.

[0024] 4 is a top view of one embodiment of a chemical indicator 410 of the present disclosure. As shown in FIG. 4, chemical indicator 410 has a first opening 422 and a second opening 424 that are in fluid communication with a chemical indicator composition 426 located on or within chamber 425 via a serpentine fluid path 414. During use, sterilant gas enters first opening 422 and second opening 424 and then diffuses along serpentine fluid path 414 to the chemical indicator composition 426 contained on or within chamber 425, where it reacts with chemical indicator composition 426. First opening 422 and second opening 424 each have a height H and a width W. The height H of the two openings 422 and 424 is the vertical distance across the openings between the first and second sheets, and the width W of the two openings 422 and 424 is the vertical distance across the openings between the sidewalls of the openings formed by the grooves or notches in the third sheet.

[0025] Figure 5 is a top view of one embodiment of a chemical indicator 510 of the present disclosure. As shown in Figure 5, chemical indicator 510 includes multiple fluid pathways 514 and multiple chemical indicator compositions 526. During use, sterilant gas enters and diffuses along each of the multiple fluid pathways 514 to the multiple chemical indicator compositions 526, where it reacts with the chemical indicator compositions 526. Each of the fluid pathways 514 in this embodiment of chemical indicator 510 of the present disclosure may have a length that is different from the length of all of the other fluid pathways 514. Thus, each of the chemical indicator compositions 526 that are in fluid communication with the ambient environment via the multiple fluid pathways 514 may change color after different lengths of exposure to the sterilant.

[0026] Figure 6 is a top view of one embodiment of a chemical indicator 610 of the present disclosure. As shown in Figure 6, chemical indicator 610 is an array of fluid pathways, each in fluid communication with the surroundings and a chemical indicator composition. This array allows for customization of each component to respond to sterilant gas under a specific set of sterilization parameters. Thus, chemical indicator 610 may be suitable for monitoring a number of different sterilization protocols.

[0027] 7 is a cross-sectional view of one embodiment of a chemical indicator 710 of the present disclosure. Chemical indicator 710 includes a first sheet 711, a second sheet 712, and a fluid pathway 714. First sheet 711 defines the bottom of the fluid pathway and, in the embodiment shown, includes notches or grooves that form the sidewalls of the fluid pathway. Second sheet 712 defines the top of the fluid pathway. Fluid pathway 714 is thus integral with first sheet 711. Fluid pathway 714 provides a conduit through which a sterilizing gas, such as hydrogen peroxide, steam, or ethylene oxide, travels to a chamber containing the chemical indicator composition during a sterilization cycle.

[0028] 8 is a cross-sectional view of one embodiment of a chemical indicator 810 of the present disclosure. Chemical indicator 810 includes a first sheet 811, a second sheet 812, and a fluid pathway 814. First sheet 811 defines the bottom of fluid pathway 814. Second sheet 812 defines the top of the fluid pathway and, in the embodiment shown, includes notches or grooves that form the sidewalls of the fluid pathway. Fluid pathway 814 is thus integral with second sheet 812. Fluid pathway 814 provides a conduit through which a sterilizing gas, such as hydrogen peroxide, steam, or ethylene oxide, travels to a chamber containing the chemical indicator composition during a sterilization cycle.

[0029] 9 is a perspective view of a process challenge device including a chemical indicator of the present disclosure. The process challenge device 915 comprises a container 916 having its own fluid path that provides fluid communication between the environment and the internal contents of the container 916 via a first opening 917 and, optionally, a second opening 918. The container 916 houses a chemical indicator 910. During use, sterilant gas enters the first opening 917, passes through the chemical indicator 910, and exits through the second opening 918. The process challenge device 915 may include a constriction 919 that restricts the flow of gas through the container 916.

[0030] As described above, the chemical indicator of the present disclosure includes a first sheet, a second sheet, and a third sheet. Such sheets may be formed from virtually any material that can be fabricated in sheet form. For example, the sheets may be formed from paper, a polymeric material such as a plastic film, or a metal foil, and the individual sheets may be formed from different materials. To be suitable for use in detecting a color change in the chemical indicator composition of the indicator, it is desirable that at least one of the first sheet and the second sheet be somewhat transparent or translucent so that the color change on the indicator can be observed. In some embodiments, at least one of the first sheet and the second sheet must be sufficiently translucent or transparent to observe the color of the indicator. For use of the indicator in monitoring a hydrogen peroxide sterilization process, the sheets are preferably formed from a material other than paper and that does not retain significant amounts of hydrogen peroxide. Particularly suitable materials from which the sheets of the present disclosure can be formed include polyester, vinyl rubber, EPDM rubber, polyethylene, polypropylene, and polystyrene. Preferably, the chemical indicator composition reacts only with a sterilant that reaches the chemical indicator composition by diffusing along a fluid pathway. In one embodiment, at least the first and second sheets should be substantially impermeable to the sterilant.

[0031] The sheets of the chemical indicator of the present disclosure may be adhered to one another by laminating the sheets together using heat and pressure with a laminator. Alternatively, the sheets may be adhered to one another using an adhesive. Preferably, the adhesive should prevent delamination of the three sheets during use and should not adversely affect the sterilant, thereby affecting the color change of the chemical indicator composition. Acceptable adhesives for adhering the sheets to one another include natural adhesives such as rubber-based adhesives, and synthetic adhesives such as synthetic rubber adhesives, acrylic adhesives, and silicone adhesives.

[0032] As described above, the third sheet of the chemical indicator forms the sides of the fluid pathway. In some preferred embodiments, the third sheet may include a groove or cutout region. Alternatively, the third sheet itself is formed from two sheets positioned proximate to one another. In this embodiment, the third sheet includes two substantially coplanar sheets, with the sheets having sides separated from one another by a distance equal to the width W of the fluid pathway for at least a portion of the distance between them. When the third sheet includes a groove or cutout region, the groove or cutout region is created by removing a partial-thickness region of the sheet (to form the groove) or a full-thickness region of the sheet (to form the cutout region). Removal of the thickness of the sheet can be accomplished using a knife or other cutting means, such as a laser cutter. In some embodiments, the first sheet and the third sheet are monolithic, and in some other embodiments, the second sheet and the third sheet are monolithic.

[0033] The fluid pathway of the chemical indicator of the present disclosure is formed from the overlapping portions of the first sheet, the second sheet, and the third sheet. The fluid pathway has a length L. The length L of the fluid pathway can be any convenient length. In one embodiment, the fluid pathway has a length L of 10 cm or less. The fluid pathway has a first opening and a second opening, each of which has a height H and a width W. The height H of the two openings is the vertical distance at the opening between the first sheet and the second sheet, and the width W of the two openings is the vertical distance at the opening between the sidewalls of the opening formed by the groove or notch in the third sheet. In some embodiments, the aspect ratio, which is the ratio of the width to the height (W / H) of the two openings, should be at least 4 (4:1).

[0034] The height of the indicator's fluid path is determined by the height of the third sheet, or alternatively, by the distance between the first and second sheets if one or more additional layers are present that form part of the sides of the fluid path, thereby increasing the height of the fluid path. In indicator configurations that include a third sheet that includes a film layer and an adhesive layer, the number of adhesive and film layers present in the indicator configuration and their respective thicknesses determine the height of the fluid path. The height and width dimensions of the channel, along with the number of openings in the indicator, control the amount of sterilant vapor that enters the indicator during the sterilization process.

[0035] The fluid pathway can provide a process challenge to the indicator. For example, the tortuous fluid pathway shown in FIG. 4 provides a greater challenge to diffusing the sterilant along the fluid pathway to the chamber containing the chemical indicator composition than a straight fluid pathway. Other ways to configure the fluid pathway to provide a process challenge include reducing the height and / or width of the first opening and / or the second opening, treating the walls of the fluid pathway with a chemical that reacts with and decomposes the sterilant, treating the walls with a chemical that absorbs and retains the sterilant, and incorporating a barrier material within the fluid pathway that reduces the flow of sterilant along the pathway, such as to the chemical indicator composition.

[0036] The chemical indicators of the present disclosure may include one fluid path or two or more fluid paths. In some embodiments of the present disclosure, one fluid path is in fluid communication with the surroundings and a chamber containing a chemical indicator composition, as shown in Figure 2. In other embodiments of the present disclosure, two fluid paths are in fluid communication with both the surroundings and a centrally located chamber containing a chemical indicator composition, as shown in Figures 3 and 4. In other embodiments of the present disclosure, several fluid paths are in fluid communication with the surroundings and a chamber containing a chemical indicator composition, as shown in Figures 5 and 6.

[0037] The chemical indicator composition of the disclosed indicator may include one or more dyes and pigments that change from one color to another (including from colorless to colored, or vice versa) upon interaction with a sterilant. In the case of steam sterilants, a typical interaction between the indicator and the sterilant involves the production of sulfur anions, which react with lead or another metal to create black metal sulfides. In the case of ethylene oxide sterilants, a typical interaction between the indicator and the sterilant involves the direct reaction of a dye or pigment with ethylene oxide, resulting in a color change. Another approach to indicating ethylene oxide involves the use of an indicator composition containing a metal salt, which, upon reaction with ethylene oxide, results in a pH change that can be detected by a pH indicator dye. In the case of hydrogen peroxide sterilants, a typical interaction between the indicator and the sterilant involves the oxidation of the indicator dye or pigment. Another approach involves the oxidation of a metal salt, creating highly reactive oxygen radicals that subsequently react with the dye or pigment. The disclosed chemical indicator composition may contain two or more dyes or pigments, or a mixture of one or more dyes and one or more pigments. An example of a dye and pigment mixture is an indicator composition containing a pigment that is stable to interaction with hydrogen peroxide and a dye that reacts with hydrogen peroxide. For example, a red pigment can be combined with an excess of a blue dye to create a predominantly blue chemical indicator composition, which, upon interaction with hydrogen peroxide, can reveal the red pigment by turning it pink due to bleaching (to colorless) of the blue dye by the action of hydrogen peroxide. In some embodiments, the dye or pigment is selected from methane, monoazo, diazo, triazo, diazine, thiazine, cyanine, xanthene, oxazine, anthraquinone, benzodifuranone, phthalocyanine, quinophthalone, and nitro and nitroso colorants, and combinations thereof.

[0038] An overcoat may be applied to the chemical indicator composition. Such an overcoat can reduce or enhance the reactivity of the indicator composition to sterilization gas. For example, an overcoat containing an oxidizable compound, such as mercaptobenzothiazole, retards the reaction of hydrogen peroxide with the indicator composition. The overcoat may also reduce the possibility of transfer of the chemical indicator composition to instruments that may come into contact with the chemical indicator of the present disclosure before, during, or after sterilization. Many compositions may be used as the overcoat. For example, ethyl cellulose is a particularly preferred overcoat material.

[0039] The chemical indicator composition of the present disclosure is located within or on a chamber that is in fluid communication with the fluid pathway. The chemical indicator composition may be disposed within or on the chamber using any convenient printing or coating method, including inkjet printing, knife coating, gravure coating, flexographic coating, and the like. The chamber may be formed in the first or second sheet by removing a portion of the sheet's material to provide a cutout area or by applying pressure to the sheet at elevated temperatures. Alternatively, the chamber may be a completely separate entity that can be applied to the first or second sheet using adhesives or lamination methods. Alternatively, the chamber may be formed in the third sheet of the indicator of the present disclosure using any convenient method, including those listed above. In some embodiments, the chamber is simply the location on the first, second, or third sheet where the indicator is located. For example, the indicator may be coated or applied directly to an area of ​​the first, second, or third sheet, as long as it is in fluid communication with the fluid pathway. With respect to the size of the chamber, the portion of the length of the fluid pathway that it occupies can be relatively small or relatively large. For example, in some embodiments of the present disclosure, the chemical indicator composition extends the entire length of the fluid pathway. What is important about the chamber is that it does not adversely affect the color change of the indicator composition, either by adversely affecting the flow of sterilant along the fluid pathway or by adversely affecting the color change characteristics of the indicator composition.

[0040] The process challenge device of the present disclosure includes a container. The container may be made of any material that is substantially impermeable to the sterilant gas and compatible with the sterilant. For example, the container may be made of a metal such as stainless steel, a plastic such as poly(carbonate), or glass for use in hydrogen peroxide sterilization, but cannot be made of paper. Similarly, the restriction or constriction in the process challenge device may be made of a variety of materials.

[0041] Illustrative Embodiments 1. A chemical indicator comprising: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a fluid path; a chamber; the fluid path includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of the fluid pathway defined by a first sheet, a top of the fluid pathway defined by a second sheet, and sides of the fluid pathway defined by a third sheet, the fluid pathway having a first end defining a first opening and a second end defining a second opening; The chemical indicator, wherein a first end of the fluid pathway is configured to be in fluid communication with the ambient and a second end of the fluid pathway is configured to be in fluid communication with the chamber.

[0042] 2. A chemical indicator comprising: a first sheet that is substantially impermeable to the sterilant; a second sheet substantially impermeable to the sterilant disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a fluid path; a chamber; the fluid path includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of the fluid pathway defined by a first sheet, a top of the fluid pathway defined by a second sheet, and sides of the fluid pathway defined by a third sheet, the fluid pathway having a first end defining a first opening and a second end defining a second opening; The chemical indicator, wherein a first end of the fluid pathway is configured to be in fluid communication with the ambient and a second end of the fluid pathway is configured to be in fluid communication with the chamber.

[0043] 3. A chemical indicator comprising: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between and directly adjacent to the first and second sheets; a fluid path; a chamber; the fluid path includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of the fluid pathway defined by a first sheet, a top of the fluid pathway defined by a second sheet, and sides of the fluid pathway defined by a third sheet, the fluid pathway having a first end defining a first opening and a second end defining a second opening; The chemical indicator, wherein a first end of the fluid pathway is configured to be in fluid communication with the ambient and a second end of the fluid pathway is configured to be in fluid communication with the chamber.

[0044] 4. A chemical indicator comprising: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a first adhesive layer disposed between and immediately adjacent the first and third sheets; a second adhesive layer disposed between and immediately adjacent the second and third sheets; a fluid path; a chamber; the fluid path includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of the fluid pathway defined by a first sheet, a top of the fluid pathway defined by a second sheet, and sides of the fluid pathway defined by a third sheet, the fluid pathway having a first end defining a first opening and a second end defining a second opening; The chemical indicator, wherein a first end of the fluid pathway is configured to be in fluid communication with the ambient and a second end of the fluid pathway is configured to be in fluid communication with the chamber.

[0045] 5. A chemical indicator comprising: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a first fluid path; a second fluid path; and a chamber; each of the first and second fluid paths includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of each of the first and second fluid paths is defined by a first sheet, a top of each of the first and second fluid paths is defined by a second sheet, and a side of each of the first and second fluid paths is defined by a third sheet, each of the first and second fluid paths having a first end defining a first opening and a second end defining a second opening; a first end of the first fluid path configured to be in fluid communication with the ambient environment and a second end of the first fluid path configured to be in fluid communication with the chamber; a first end of the second fluid path configured to be in fluid communication with the chamber and a second end of the second fluid path configured to be in fluid communication with the ambient; The chemical indicator, wherein the chamber is in fluid communication with the surroundings only through the first opening of the first fluid path and the second opening of the second fluid path.

[0046] 6. A chemical indicator comprising: a first sheet that is substantially impermeable to the sterilant; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet, the third sheet being substantially impermeable to the sterilant; a first fluid path; a second fluid path; and a chamber; each of the first and second fluid paths includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of each of the first and second fluid paths is defined by a first sheet, a top of each of the first and second fluid paths is defined by a second sheet, and a side of each of the first and second fluid paths is defined by a third sheet, each of the first and second fluid paths having a first end defining a first opening and a second end defining a second opening; a first end of the first fluid path configured to be in fluid communication with the ambient environment and a second end of the first fluid path configured to be in fluid communication with the chamber; a first end of the second fluid path configured to be in fluid communication with the chamber and a second end of the second fluid path configured to be in fluid communication with the ambient; The chemical indicator, wherein the chamber is in fluid communication with the surroundings only through the first opening of the first fluid path and the second opening of the second fluid path.

[0047] 7. A chemical indicator comprising: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between and directly adjacent to the first and second sheets; a first fluid path; a second fluid path; and a chamber; each of the first and second fluid paths includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of each of the first and second fluid paths is defined by a first sheet, a top of each of the first and second fluid paths is defined by a second sheet, and a side of each of the first and second fluid paths is defined by a third sheet, each of the first and second fluid paths having a first end defining a first opening and a second end defining a second opening; a first end of the first fluid path configured to be in fluid communication with the ambient environment and a second end of the first fluid path configured to be in fluid communication with the chamber; a first end of the second fluid path configured to be in fluid communication with the chamber and a second end of the second fluid path configured to be in fluid communication with the ambient; The chemical indicator, wherein the chamber is in fluid communication with the surroundings only through the first opening of the first fluid path and the second opening of the second fluid path.

[0048] 8. A chemical indicator comprising: A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a first adhesive layer disposed between and immediately adjacent the first and third sheets; a second adhesive layer disposed between and immediately adjacent the second and third sheets; a first fluid path; a second fluid path; and a chamber; each of the first and second fluid paths includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; a bottom of each of the first and second fluid paths is defined by a first sheet, a top of each of the first and second fluid paths is defined by a second sheet, and a side of each of the first and second fluid paths is defined by a third sheet, each of the first and second fluid paths having a first end defining a first opening and a second end defining a second opening; a first end of the first fluid path configured to be in fluid communication with the ambient environment and a second end of the first fluid path configured to be in fluid communication with the chamber; a first end of the second fluid path configured to be in fluid communication with the chamber and a second end of the second fluid path configured to be in fluid communication with the ambient; The chemical indicator, wherein the chamber is in fluid communication with the surroundings only through the first opening of the first fluid path and the second opening of the second fluid path.

[0049] 9. A flat sterilization process challenge device, comprising: A container containing a chemical indicator, the chemical indicator comprising: a chamber containing a chemical indicator composition; A first sheet; a second sheet disposed in overlapping relation to the first sheet; a container comprising: a third sheet disposed between the first sheet and the second sheet, the third sheet including a cut-out area to define a first fluid path; a second fluid path between the ambient and the chemical indicator; Equipped with a first fluid pathway defined by the first sheet, the second sheet, and the third sheet, the fluid pathway including a first opening and a second opening; a first opening providing fluid communication with an interior of the container; A flat sterilization process challenge device, wherein the second opening of the first fluid pathway is in fluid communication with the chamber such that the chamber is in fluid communication with the interior of the container only through the first opening of the fluid pathway.

[0050] 10. A flat sterilization process challenge device, comprising: A container containing a chemical indicator, the chemical indicator comprising: a chamber containing a chemical indicator composition; A first sheet; a second sheet disposed in overlapping relation to the first sheet; a container comprising: a third sheet disposed between the first sheet and the second sheet, the third sheet including a cut-out area to define a first fluid path; a second fluid path between the ambient and the chemical indicator; a first fluid pathway defined by the first sheet, the second sheet, and the third sheet, the first fluid pathway having a length L of 10 cm or less and including a first opening and a second opening; the first opening provides fluid communication with the interior of the container and has a width W and a height H such that the width-to-height aspect ratio W / H is at least 4 (4:1); A flat sterilization process challenge device, wherein the second opening of the first fluid pathway is in fluid communication with the chamber such that the chamber is in fluid communication with the interior of the container only through the first opening of the fluid pathway.

[0051] 11. A flat sterilization process challenge device comprising: A container containing a chemical indicator, the chemical indicator comprising: a chamber containing a chemical indicator composition; A first sheet; a second sheet disposed in overlapping relation to the first sheet; a container comprising: a third sheet disposed between and immediately adjacent to the first and second sheets, the third sheet including a cut-out region for defining a first fluid pathway; a first fluid pathway defined by the first sheet, the second sheet, and the third sheet, the first fluid pathway having a length L of 10 cm or less and including a first opening and a second opening; a second fluid path between the ambient and the chemical indicator; the first opening provides fluid communication with the interior of the container and has a width W and a height H such that the width-to-height aspect ratio W / H is at least 4 (4:1); A flat sterilization process challenge device, wherein the second opening of the fluid pathway is in fluid communication with the chamber such that the chamber is in fluid communication with the interior of the container only through the first opening of the fluid pathway.

[0052] 12. A flat sterilization process challenge device comprising: A container containing a chemical indicator, the chemical indicator comprising: a chamber containing a chemical indicator composition; A first sheet; a second sheet disposed in overlapping relation to the first sheet; a container comprising: a third sheet disposed between the first sheet and the second sheet, the third sheet including a cut-out area to define a first fluid path; a first adhesive layer disposed between and immediately adjacent the first and third sheets; a second adhesive layer disposed between and immediately adjacent the second and third sheets; a first fluid pathway defined by the first sheet, the second sheet, and the third sheet, the first fluid pathway having a length L of 10 cm or less and including a first opening and a second opening; the first opening provides fluid communication with the interior of the container and has a width W and a height H such that the width-to-height aspect ratio W / H is at least 4 (4:1); a second opening of the fluid pathway in fluid communication with the chamber such that the chamber is in fluid communication with the interior of the container only through the first opening of the fluid pathway; A flat sterilization process challenge device, wherein the second opening of the first fluid pathway is in fluid communication with the chamber such that the chamber is in fluid communication with the interior of the container only through the first opening of the fluid pathway.

[0053] 13. A method for monitoring a sterilization process, comprising: placing the chemical indicator of any one of the previous embodiments in a sterilization chamber; performing a sterilization process; and analyzing the chemical indicator to determine whether the sterilization process was successful.

[0054] 14. The chemical indicator of any one of the previous embodiments, wherein the first sheet and the third sheet are combined into a single monolithic layer.

[0055] 15. The chemical indicator of any one of the previous embodiments, wherein the second sheet and the third sheet are combined into a single monolithic layer.

[0056] 16. A chemical indicator according to any one of the preceding embodiments, wherein only one fluid path connects the chamber with the surroundings.

[0057] 17. The chemical indicator of any one of the preceding embodiments, wherein each of the first and second fluid paths, if present, has a length L of 10 cm or less.

[0058] 18. A chemical indicator described in any one of the preceding embodiments, wherein the first opening of the fluid pathway provides fluid communication with the interior of the container and has a width W and a height H, such that the aspect ratio of width to height W / H is at least 4 (4:1).

[0059] 19. The chemical indicator of any one of the preceding embodiments, wherein at least one of the first fluid path or the second fluid path, if present, is linear.

[0060] 20. A chemical indicator described in any one of the preceding embodiments, wherein each of the first fluid path and the second fluid path, if present, comprises a channel having a length, a width, and a height, and the width and height of at least a portion of the channel define the width and height of an opening of the fluid path.

[0061] 21. The chemical indicator of any one of the previous embodiments, wherein the chamber is defined by a cut-out area in the third sheet.

[0062] 22. The chemical indicator of any one of the preceding embodiments, wherein the chamber is substantially centrally located between two openings.

[0063] 23. The chemical indicator of any one of the previous embodiments, wherein the chamber is defined as the portion of the fluid pathway that contains the chemical indicator composition.

[0064] 24. A chemical indicator according to any one of the previous embodiments, wherein the chamber has a substantially circular shape.

[0065] 25. A chemical indicator according to any one of the previous embodiments, wherein the chamber has the same shape as the bottom of the fluid path.

[0066] 26. A chemical indicator according to any one of the previous embodiments, wherein the chamber is a portion along the length of a fluid pathway.

[0067] 27. A chemical indicator according to any one of the previous embodiments, wherein the chamber has a substantially circular shaped portion and a substantially rectangular portion.

[0068] 28. The chemical indicator of any one of the preceding embodiments, wherein the chamber, if present, extends substantially along the entire length of the first fluid path and / or the second fluid path.

[0069] 29. The chemical indicator of any one of the preceding embodiments, wherein the chamber, if present, extends substantially along the entire length of the first fluid path and / or the second fluid path, and the chemical indicator composition is present along substantially the entire length of the chamber.

[0070] 30. The chemical indicator of any one of the previous embodiments, further comprising a second fluid pathway arranged to connect the chamber to the surroundings.

[0071] 31. The chemical indicator of any one of the preceding embodiments, wherein the fluid pathway is configured to allow the sterilant to travel along the fluid pathway in a plane parallel to a plane defined by the first sheet and the second sheet.

[0072] 32. The chemical indicator of any one of the preceding embodiments, wherein the fluid pathway extends from a first edge of the first sheet and the second sheet to a second edge of the first sheet and the second sheet.

[0073] 33. The chemical indicator of any one of the previous embodiments, wherein the chemical indicator is adhered to at least one of the first sheet and the second sheet.

[0074] 34. The chemical indicator of any one of the previous embodiments, wherein the chemical indicator is in contact with at least one of the first sheet and the second sheet.

[0075] 35. The chemical indicator of any one of the previous embodiments, further comprising a barrier material in the fluid pathway to regulate the flow of sterilant.

[0076] 36. The chemical indicator of any one of the previous embodiments, wherein one or both of the first sheet and the second sheet are substantially impermeable to the sterilant.

[0077] 37. A process challenge device comprising one or more chemical indicators according to any one of the preceding embodiments, wherein the chemical indicator is within a container comprising an additional fluid pathway that provides fluid communication between the surroundings and the container.

[0078] 38. A process challenge device comprising one or more chemical indicators according to any one of the preceding embodiments, wherein the chemical indicator is within a container comprising an additional fluid pathway providing fluid communication between the surroundings and the container, the additional fluid pathway being configured to regulate the flow of sterilant to the chemical indicator.

[0079] 39. A flat sterilization process challenge device according to any one of the preceding embodiments, directed to a process challenge device, wherein one or both of the first sheet and the second sheet are substantially impermeable to the sterilant.

[0080] 40. A flat sterilization process challenge device according to any one of the preceding embodiments, directed to a process challenge device, wherein the first sheet and the second sheet are substantially less permeable to the sterilant than the fluid pathway.

[0081] 41. A flat sterilization process challenge device according to any one of the preceding embodiments, directed to a process challenge device, wherein the flow rate of sterilant through the fluid pathway is greater than five times the flow rate of sterilant through the first sheet and the second sheet.

[0082] 42. A flat sterilization process challenge device according to any one of the preceding embodiments, wherein the flat sterilization process challenge device is intended for a process challenge device and the aspect ratio of the length of the fluid pathway to the opening is dimensioned to provide a restriction to the transport of the sterilant (by flow, diffusion, etc.) to reach the chemical indicator composition to mimic a medical device lumen.

[0083] 43. A flat sterilization process challenge device according to any one of the preceding embodiments, directed to the process challenge device, wherein the chemical indicator is centrally positioned relative to the length of the further fluid path to simulate sterilization of the location of the medical device lumen furthest from the periphery.

[0084] 44. The chemical indicator of any one of the preceding embodiments, wherein the fluid pathway is configured to restrict the transport of the sterilant (by flow, diffusion, etc.) to reach the chemical indicator composition for a given sterilization process.

[0085] 45. The chemical indicator of any one of the preceding embodiments, wherein the chemical indicator composition is configured to change color in response to exposure to a given dose of a sterilant.

[0086] 46. ​​The chemical indicator of any one of the previous embodiments, wherein the first sheet, the second sheet, and the third sheet are formed of a polymeric material.

[0087] 47. The chemical indicator of any one of the previous embodiments, wherein the sterilant is selected from hydrogen peroxide, steam, and ethylene oxide.

[0088] 48. The chemical indicator of any one of the preceding embodiments, wherein the chemical indicator is configured to monitor a sterilization process occurring at a temperature of 135°C or less.

[0089] 49. An array of chemical indicators comprising two or more chemical indicators according to any one of the preceding embodiments.

[0090] 50. An array of chemical indicators according to any one of the preceding embodiments, wherein the array is targeted and the fluid pathways of each of the chemical indicators regulate the flow of sterilant in a manner different from each other. [Example]

[0091] General Method for Preparation of Hydrogen Peroxide Indicator An 8-inch-wide piece of clear, untreated poly(ethylene terephthalate) (PET) film (7 mil thick) was attached to a flat surface using adhesive tape. One liner of a 25-inch length of 6-inch-wide transfer tape (3M™ 9996 Transfer Adhesive Tape) was then removed, and the adhesive side of the transfer tape was carefully placed onto the PET film, minimizing air bubble formation between the adhesive layer and the film. (In some examples, as described below, 3M™ 9965 Double-Coated Polyester Diagnostic Tape was placed on the PET film instead of 3M™ 9996 Transfer Adhesive Tape.) A roller was then used to remove any air bubbles that may have formed. This process was repeated to adhere a piece of transfer adhesive tape to the other surface of the PET film. The double-sided PET film was then carefully trimmed to a length of 23 inches and a width of 6 inches. Using an Epilog Mini / Helix Model 8000 high-power 50-watt CO₂ laser engraver, either 60 indicator frames measuring 2 inches long and 0.78 inches wide or 30 indicator frames measuring 4 inches long and 0.78 inches wide were cut from the PET / adhesive construction. Each frame contained a 5 mm wide cutout running centrally through all layers of the PET / adhesive construction along the largest dimension of the frame. (The cutout portion of the construction serves as the side of the fluid path within the indicator.) Next, one of the liners of the PET / adhesive construction / indicator frame was removed, and the indicator frame was pressed into place using the indicator frame's adhesive onto a stripe coating of chemical indicator composition coated onto either a poly(styrene) or polyester substrate. (The indicator frame was positioned onto the stripe coating so that the chemical indicator composition was contained within the generated fluid path.) The other liner of the indicator frame construction was then removed and replaced with untreated 3 mil thick PET or biaxially oriented poly(propylene) film (BOPP), which formed the top of the fluid path.The edges of the indicator were trimmed to remove excess film and adhesive, and one or both ends of the indicator were cut to provide one or more openings to the perimeter of the fluid path. The height of the fluid path in the indicator configuration was 9 mil.

[0092] To prepare indicator constructions with fluid path heights greater than 9 mils, thicker PET films (eg, 5 mil PET films) or more layers of the PET / adhesive construction are used within the indicator construction.

[0093] The chemical indicator composition coated onto the substrate used in some examples was an indicator stripe cut from 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248. Alternatively, some examples used 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248 chemical indicator composition prepared in liquid form and stripe-coated onto a substrate, as described below. Suitable substrates include polyester and polystyrene films. In all examples where 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248 was used in the indicator construction, and in some examples, as described below, the liquid form of the chemical indicator composition was coated onto a substrate, and the dried coated chemical indicator composition was overcoated with a 13% wt / wt solution of ethyl cellulose in methanol, followed by drying at 70° C. for 5 minutes.

[0094] To prepare the indicator compositions used in the examples in liquid form, the following procedure was followed. Step 1: Red Premix: Shellac (81.8 grams) was combined with 6.8 grams of Quindo Red 19 (available from Sun Chemical, Cincinnati, Ohio) and 11.4 grams of 2-propanol and milled overnight using a glass marble in a glass jar on a ball roll mill. Step 2: Separately, 70 grams of shellac, 22.9 grams of Rhoplex I-545 (available from Dow Chemical, Midland, MI), 2.3 grams of triethanolamine (available from Sigma Aldrich, St. Louis, MO), and 0.6 grams of Alkali Blue 6B (available from Sigma Aldrich, St. Louis, MO) were combined. Step 3: The blue mixture from step 2 was combined with 4.2 grams of the red premix from step 1. The mixture was mixed overnight by rolling in a roller mixer. Step 4: The resulting chemical indicator composition was coated onto untreated poly(styrene) film in some examples, or onto untreated polyester film in other examples, using a #8 Meyer bar, and then dried in an oven at 80°C for 5 minutes.

[0095] Common Test Methods for Hydrogen Peroxide Indicators Hydrogen peroxide indicators were prepared as described above and tested for a color change from blue to pink upon exposure to hydrogen peroxide using a Sterrad® 100S Hydrogen Peroxide Sterilization System (available from ASP, Irvine, CA). After exposing the indicators to hydrogen peroxide using a 100S sterilization cycle, the indicators were removed from the sterilizer, placed on a sheet of paper or film, and scanned using a photocopier with the following settings: JPEG image, 300 dpi resolution, and medium color output. The resulting images were then subjected to image analysis using Image J software (a public domain Java-based image processing program). Using the program, each color image was first divided into corresponding red, blue, and green color components (channels). Only the red component of the image was further analyzed. The red intensity values ​​of each image were plotted against distance from each end of the indicator [red intensity (0-255) vs. distance (inches)] using Excel software (available from Microsoft, Seattle, WA). Low red intensity values ​​correspond to low exposure of the chemical indicator composition to hydrogen peroxide (corresponding to the dark areas of the strip images shown in Figures 10-14), while high red intensity values ​​correspond to high exposure of the chemical indicator composition to hydrogen peroxide (corresponding to the light areas of the strip images shown in Figures 10-14). Red intensity values ​​above about 200 correspond to the red color of the chemical indicator composition, typically achieved with full exposure to HO vapor. Red intensity values ​​below about 50 correspond to the blue color of the chemical indicator composition, typically achieved with very little exposure to HO vapor.

[0096] Example 1 Two-inch long hydrogen peroxide indicators were prepared using one layer of the PET / adhesive construction (one layer of 7 mil untreated PET film laminated on both sides with 1 mil thick 3M™ 9996 Transfer Adhesive Tape) and an indicator stripe prepared by coating the 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248 chemical indicator composition as described above. The resulting fluid path height was 9 mil. Both ends of the indicator were cut to provide openings to the periphery at both ends. The indicator was subjected to exposure to hydrogen peroxide vapor using a Sterrad® 100S sterilizer using the standard "100S" sterilization cycle. The results of this test are shown in Table 10. The results show that the central region of the indicator changed from blue to pink, but not as much as the color change at the two ends of the indicator, thus demonstrating successful monitoring of the sterilization process.

[0097] Example 2 Two-inch long hydrogen peroxide indicators were prepared using one layer of the PET / adhesive construction (one layer of 7 mil untreated PET film laminated on both sides with 1 mil thick 3M™ 9996 Transfer Adhesive Tape) and an indicator stripe prepared by coating the 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248 chemical indicator composition as described above. The resulting fluid path height was 9 mil. One end of the indicator was cut to provide an opening to the periphery at one end. The indicator was subjected to exposure to hydrogen peroxide vapor using a Sterrad® 100S sterilizer using the standard "100S" sterilization cycle. The results of this testing are shown in Table 11. The results show that the area of ​​the indicator proximal to the indicator opening changes from blue to pink, the area of ​​the indicator proximal to the closed end of the indicator remains relatively blue, and the central area of ​​the indicator exhibits some pinkness, but not as pink as the area of ​​the indicator proximal to the indicator opening, thus demonstrating successful monitoring of the sterilization process.

[0098] Example 3 A 4-inch long hydrogen peroxide indicator was prepared using one layer of the PET / adhesive construction (one layer of 7 mil untreated PET film laminated on both sides with 1 mil thick 3M™ 9996 Transfer Adhesive Tape) and an indicator stripe prepared by coating the 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248 chemical indicator composition as described above. The resulting fluid path height was 9 mil. The ends of the indicator were cut to provide openings to the periphery at both ends. The indicator was subjected to exposure to hydrogen peroxide vapor using a Sterrad® 100S sterilizer using the standard "100S" sterilization cycle. The results of this test are shown in Table 12. The results show minimal color change from blue in the center region of the indicator, but a change from blue to pink at the two ends of the indicator, thus demonstrating successful monitoring of the sterilization process.

[0099] Example 4 A 4-inch long hydrogen peroxide indicator was prepared using one layer of the PET / adhesive construction (one layer of 7 mil untreated PET film laminated on both sides with 1 mil thick 3M™ 9996 Transfer Adhesive Tape) and an indicator stripe prepared by coating the 3M Comply™ Hydrogen Peroxide Chemical Indicator 1248 chemical indicator composition as described above. The resulting fluid path height was 9 mil. One end of the indicator was cut to provide an opening to the periphery at one end. The indicator was subjected to exposure to hydrogen peroxide vapor using a Sterrad® 100S sterilizer using a standard "100S" sterilization cycle. The results of this test are shown in Table 13. The results show that the region of the indicator proximal to the indicator opening changed from blue to pink, while the region of the indicator proximal to the closed end of the indicator remained relatively blue, with minimal color change from blue in the central region of the indicator, thus demonstrating successful monitoring of the sterilization process.

[0100] Examples 5 to 48 Examples 5-48 demonstrate indicator performance as a function of several configuration variables, as listed in the table below. The indicators were subjected to exposure to hydrogen peroxide vapor using a Sterrad® 100S sterilizer. Performance is characterized using three different responses. Delta Red Intensity is the difference in red intensity between the open and closed ends of the indicator fluid path. Delta Red Intensity values ​​can range from 0 to 255 and are a measurement of blue / red color contrast. Higher Delta Red Intensity values ​​indicate a greater difference in blue / red color balance when comparing the ends of the indicator fluid path. Vmax Red is the maximum value of the first derivative of the red intensity profile over the length of the indicator fluid path. Higher Vmax Red Intensity values ​​indicate a sharper blue-to-red transition across the indicator's moving front. Front location is the position of the indicator's moving front, corresponding to the location along the indicator's fluid path (measured from the open end) where Vmax Red Intensity is observed. Front location is also provided as a percentage of the indicator strip's total length. While all of the indicators exemplified herein represent useful configurations, several of them are preferred: indicator configurations with a delta red intensity value greater than 130, a Vmax red intensity greater than 0.5, a front location greater than 10 mm, or alternatively, a total indicator strip length greater than 20% are preferred.

[0101] [Table 1]

[0102] Examples 49 to 54 Examples 49-54 demonstrate the performance of the indicator as a function of different cycle types in various sterilizers, as listed in the table below. The sterilizers used include the ASP Sterrad® 100S, ASP Sterrad® 100NX, ASP Sterrad® NX, and Sterilucent PSD-85. The results show that the indicator is capable of monitoring hydrogen peroxide sterilization cycles in a variety of sterilizers.

[0103] [Table 2]

[0104] [Table 3]

[0105] [Table 4]

[0106] Examples 55 to 60 Examples 55-60 demonstrate the indicator's ability to distinguish between complete and incomplete sterilization cycles in various sterilizers, as listed in the table below. The sterilizers used included the ASP Sterrad® 100S and the ASP Sterrad® 100NX. An incomplete cycle is equivalent to one-half of a complete cycle. Examples 55-58 further demonstrate the indicator's ability to distinguish complete from incomplete cycles for different loads placed in the sterilization chamber. Load 1 represents two trays of surgical steel instruments, each containing 10.23 lbs of instruments. Load 2 represents two trays of surgical steel instruments, each containing 10.23 lbs of instruments. Additionally, for Load 2, the tray placed on the top rack of the sterilizer also contains two protectant silicone mats (available from Advanced Sterilization Products), while the tray placed on the bottom rack of the sterilizer also contains one protectant silicone mat. The results show that the indicator can distinguish between complete and incomplete cycles for a variety of sterilizers using a variety of load conditions. In an ASP Sterrad® 100S sterilizer using Load Type 1, the front location decreased by a factor of 1.8 for incomplete cycles (indicating a front location closer to the indicator's fluid path opening). In the same sterilizer using Load Type 2, the front location decreased by a factor of 8.5 for incomplete cycles. Finally, in an ASP Sterrad® 100NX sterilizer using Load Type 1, the front location decreased by a factor of 1.2 for incomplete cycles.

[0107] [Table 5]

[0108] [Table 6]

[0109] [Table 7]

[0110] Examples 61 to 63 The following table specifies the composition of each of Examples 61 to 63. Examples 61 and 62 are control examples.

[0111] [Table 8]

[0112] Examples 63 and 64 are working indicators used for comparison with two control examples 61 and 62. All examples were constructed using the method described above. Example 61 corresponds to the same indicator configuration as Examples 63 and 64, except that Sheet 2 is absent. Example 62 corresponds to the same indicator configuration as Examples 63 and 64, except that the fluid pathway is completely sealed at both ends (i.e., the indicator of Example 62 has no openings in the fluid pathway). Indicator Examples 61-63 were subjected to exposure to hydrogen peroxide vapor using a Sterrad® 100S sterilizer. Indicator Example 64 was not exposed to a sterilization cycle. The results of this test are shown in Table 14. The results demonstrate that Comparative Example 63 performed as expected, with a distinct front located approximately 30% of the total length of the indicator strip from the open end of the fluid pathway. In contrast, Control Example 61 did not have a defined front, and the entire length of the indicator strip had an average red intensity value of 240. This indicator reached 94% of the theoretical endpoint color of red intensity (255) along the entire length of the indicator strip. Example 61 demonstrates that without Sheet 2 (i.e., no defined top to the fluid pathway), the indicator does not have a moving front. For Example 62, the results shown in Figure 14 indicate that the average red intensity was 52 along the entire length of the indicator strip. This value is nearly identical to that of Example 64 (average red intensity = 50), which corresponds to an indicator not exposed to a sterilizer. Thus, Example 62 demonstrates that when the indicator fluid pathway openings are sealed, the indicator construction is essentially impermeable to hydrogen peroxide vapor (i.e., Sheets 1, 2, and 3 are impermeable to hydrogen peroxide vapor), and exposure of the chemical indicator composition along the indicator strip occurs only when hydrogen peroxide vapor enters the channel through the openings at one or both ends of the indicator.

Claims

1. A chemical indicator comprising: a first sheet that is substantially impermeable to the sterilant; a second sheet substantially impermeable to the sterilant disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet; a fluid path; a chamber; Equipped with the fluid path includes a bottom, a top, and two sides; the chamber contains a chemical indicator composition; the bottom of the fluid pathway is defined by the first sheet, the top of the fluid pathway is defined by the second sheet, and the sides of the fluid pathway are defined by the third sheet, the fluid pathway having a first end defining a first opening and a second end defining a second opening; a first end of the fluid path configured to be in fluid communication with the ambient environment and a second end of the fluid path configured to be in fluid communication with the chamber; The chemical indicator wherein the chamber is defined by a cut-out area in the third sheet.

2. 1. A flat sterilization process challenge device comprising:

1. A container containing a chemical indicator, the chemical indicator comprising: a chamber containing a chemical indicator composition; A first sheet; a second sheet disposed in overlapping relation to the first sheet; a third sheet disposed between the first sheet and the second sheet, the third sheet including a cutout area for defining a first fluid path; a container comprising: a second fluid path between the ambient and the chemical indicator; Equipped with the first fluid path is defined by the first sheet, the second sheet, and the third sheet, the fluid path including a first opening and a second opening; the first opening provides fluid communication with the interior of the container; the second opening of the first fluid path is in fluid communication with the chamber such that the chamber is in fluid communication with the interior of the container only through the first opening of the fluid path; A flat sterilization process challenge device, wherein the chamber is defined by the cut-out area of ​​the third sheet.

3. The chemical indicator of claim 1 , wherein only one fluid path connects the chamber with the ambient.

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