BACKGROUND OF THE INVENTION

[0001] It is well known that heat destroys microorganisms. The presence of moisture accelerates this destruction by denaturing or coagulation of the proteins making up the microorganisms. Most microorganisms contain sufficient water so that moderate heat alone, e.g. 80°C-100°C, will destroy the microorganism. Many bacterial spores, on the other hand, contain substantially no water and require elevated temperatures in excess of 150°C for their destruction where dry heat is used. Hence, the destruction of such organisms is generally carried out in the presence of steam in steam sterilizers.

[0002] There are two basic types of steam sterilizers (autoclaves) - a gravity displacement autoclave and a prevacuum type sterilizer. In the gravity displacement autoclaves, steam is admitted at the top or the sides of the sterilizing chamber and, because the steam is lighter than air, forces air out the bottom of the chamber through a drain vent. Gravity displacement autoclaves are primarily used to process laboratory media, water, pharmaceutical products, regulated medical waste, and nonporous articles whose surfaces have direct steam contact. For gravity displacement sterilizers the penetration time into porous items is prolonged because of incomplete air elimination. For example, decontamination of 10 lbs of

microbiological waste requires at least 45 minutes at 121°C, because the entrapped air remaining in a load of waste greatly retards steam permeation and heating efficiency.

[0003] Prevacuum type sterilizers are similar to the gravity

displacement sterilizers except they are fitted with a vacuum pump (or ejector) to ensure air removal from the sterilizing chamber and load before the steam is admitted. By removing air, nearly instantaneous steam penetration can be provided even into porous loads.

[0004] Bowie-Dick type air removal tests are used to detect air leaks and inadequate air removal in prevacuum sterilizers. In the Bowie -Dick test, a commercially available Bowie-Dick-type test indicator is placed in the center of a test pack consisting of folded 100% cotton surgical towels prepared according to a standard test method, such as American National Standards Institute

(ANSI)/ Association for the Advancement of Medical Instrumentation

(AAMiyinternational Organization for Standards (ISO) 11140-5:2007. The test pack

LP 4545779.1 \ 35495-90648PCT is placed horizontally in the front, bottom section of a sterilizer rack, near the door and over the drain, in an otherwise empty chamber, and the sterilizer is tested.

Successful air removal is verified by a uniform color change in the Bowie-Dick-type test indicator after exposure to saturated steam at 134°C for 3.5min ± 5 sec and/or at 12FC for 15min ± 5 sec.

[0005] Inadequate air removal can result in an inadequate sterilization process, since air that is not removed from the chamber can interfere with steam contact. Thus, the air removal test is performed each day the vacuum-type steam sterilizer is used, before the first processed load. The test packs can be prepared using freshly laundered cotton surgical towels. ANSI/AAMI/ISO 11140-5:2007 requires that the towels to be folded to a size 250 mm ± 20mm in one direction and 300 mm ± 20mm in the other direction, and that the height of the test pack to be between 250 mm and 280 mm. Thus, preparation for the air removal test for users can be labor intensive, time consuming and cost prohibitive. Disposable air removal test systems including disposable test packs have been developed, but they are still costly and create waste from disposing test packs after each use.

[0006] Therefore, there is a need for an improved air removal test system that can provide indication for successful air removal in prevacuum type sterilizers.

BRIEF SUMMARY OF THE INVENTION

[0007] In one aspect, a test strip for verifying adequate air removal during a sterilization cycle of a pre -vacuum type sterilizer is provided. The test strip includes a base element, a solid indicator chemical, a wicking material, a film and a coated paper. The base element is formed from a thermally conductive material having a length and a width, and having a recess formed therein. The solid indicator chemical is deposited in the recess. The wicking material is positioned at least in part in contact with the solid indicator chemical, and extends less than the length and width of the base element. The film is positioned over the base element, the wicking material, and the solid indicator chemical. The coated paper is disposed over the film, and includes a window. The widow is arranged away from the solid indicator chemical such that a portion of the wicking material is visible through the window. The test strip is configured such the solid indicator chemical liquefies and wicks along the wicking material during a pre-vacuum sterilization cycle and changes a color of the wicking material. Further, the test strip is configured to verify adequate air removal when the color change covers the portion of the wicking material visible through the window.

[0008] In another aspect, an air removal test system for verifying adequate air removal during a sterilization cycle of a pre -vacuum type sterilizer is provided. The test system includes a specimen holder and the above described test strip. The specimen holder includes a tubular body defining an interior chamber, a closure cap sealable on a first end of the tubular body, and an end plug arranged in a second end of the tubular body. The end plug provides a single ingress and egress flow path into and out of the interior chamber. The test strip is placed in the interior chamber of the specimen holder, which is then placed in a pre-vacuum type sterilizer. In the sterilizer, the solid indicator chemical liquefies and wicks along the wicking material during a pre-vacuum sterilization cycle and changes a color of the wicking material. The test strip is configured to verify adequate air removal when the color change covers the portion of the wicking material visible through the window.

[0009] In one embodiment, the base element has an adhesive backing, for example, an acrylic adhesive. The solid indicator chemical is salicylamide, ethoxy benzomide or similar chemical, and can also include a dye. For example, the solid indicator chemical can include blue color dye present in a concentration of about 0.01 percent by weight of the indicator chemical. Further, the film is a cast polypropylene having a thickness of about 2.0 to 2.2 mils or about 3.0 to 3.2 mils. The base element can be aluminum having a thickness of about 3 mils. Further, the coated paper can have an adhesive backing and an acrylic coating thereon.

[0010] These and other features and advantages of the present invention will be apparent from the following detailed description, in conjunction with the appended claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0011] The benefits and advantages of the present invention will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0012] FIG. 1 is a top plan view of an air removal test strip according to an embodiment;

[0013] FIG. 2 is a cross-sectional view taken along line 2—2 of FIG. 1; [0014] FIG. 3 is a top perspective view of the test strip of FIG. 1 with a paper layer, an adhesive layer, and a film layer peeled off;

[0015] FIG. 4 is an exploded view of a specimen holder according to an embodiment; and

[0016] FIG. 5 is a cross-sectional view of the specimen holder of FIG.

4.

DETAILED DESCRIPTION OF THE INVENTION

[0017] While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification of the invention and is not intended to limit the invention to the specific embodiment illustrated.

[0018] FIGS. 1-3 show an embodiment of a test strip 10 for detecting air leaks and inadequate air removal in a pre-vacuum type sterilizer. The strip 10 is configured to work with a reusable specimen holder, such as those disclosed in US 7,718,125, US 7,740,802, US 7,790,105, and US 7,811,516, which are commonly assigned to the assignee of the present application, the entire contents of which are incorporated herein by reference. A specimen holder 100 according to an

embodiment is shown in FIGS. 4-5. In use, the test strip 10 is placed in the specimen holder 100 as shown in FIG. 5, which is then placed in a pre-vacuum type sterilizer for a pre-vacuum sterilization cycle to determine whether an adequate air removal in the sterilization has been achieved.

[0019] As shown in FIG. 1, the strip 10 has an open window 12 through which the wicking of an indicator chemical 14 (FIG. 2) can be observed to determine whether adequate air removal in the prevacuum has occurred as will be described below. FIG. 2 is a cross-sectional illustration of the strip 10. The strip 10 generally includes a base element 16, an adhesive layer 22, a wicking element 20, a film layer 26, an adhesive layer 30, a paper layer 28, and a solid indicator chemical 14. The base element 16 is formed from a foil or other high-heat transfer material. The adhesive layer 22 is provided on the base element 16 as a continuous layer covering substantially the entire top surface of the base element 16. The base element 16 has a length L ₁₆ and a width W ₁₆ . In this embodiment, the base element 16 is formed from an aluminum foil. A depression or recess 18 is formed in the base element 16 and the adhesive layer 22. The indicator chemical 14, which is a temperature sensitive chemical formulation, is provided in the recess 18 between the adhesive layer 22 and the wicking element 20.

[0020] The wicking element 20, such as a wicking paper is positioned on the base element 20 attached by the adhesive layer 22. FIG. 3 shows a top view of the strip with the film layer 26, the adhesive layer 30, and the paper layer 28 peeled away to illustrate the wicking element 20 arranged on the base element 20 and the adhesive layer 22. As shown, the wicking element 20 has a width W ₂ o and a length L ₂ o that is less than the width W ₁₆ and the length L ₁₆ of the base element 16. The wicking element 20 is generally centered on the base element 16 and over the indicating chemical 14 in the recess 18, such that an end portion 32 of the wicking element 20 is in contact with the indicator chemical 14. The wicking element 20 extends longitudinally along the base element 16, such that at least some portion of the wicking element is securely attached to the base element 20 by the adhesive layer 22. In this manner, the indicator chemical 14 and the wicking element 20 are bounded within the four sides of the test strip 10.

[0021] The film 26 is applied over the wicking element 20, and adhered to the base element 16 by the adhesive layer 22. The film 26 has

substantially the same width and length as the base element 16, and thus, it is attached to the base element 16 by the adhesive layer 22 in the peripheral areas around the wicking element 20. The film 26 is a transparent film, as will be discussed in more detail below. The paper layer 28 is provided with the adhesive layer 30, and applied over the film 26. The paper layer 28 and the adhesive layer 30 include the window 12 that is cut out (as seen in FIGS. 1-3) to allow for visual indication within the window 12, through the film 26.

[0022] In exemplary test strips 10, the foil element 16 and the adhesive layer 22 are formed using a 3/1000 inch (3 mil) thick adhesive label. The adhesive layer 22 on the foil 16 (to adhere to the wicking element 20 and the film 26) is an acrylic adhesive. The paper layer 28 and the adhesive layer 30 are formed from an acrylic coated paper.

[0023] The film layer 26 is formed from a cast polypropylene having a thickness of about 2.0 to 2.2 mils or 3.0 to 3.2 mils. The wicking element 20 is formed from a suitable wicking material, for example, a wicking material

commercially available from Whatman Inc. of Piscataway, New Jersey under the product identifier Whatman 1. This wicking material is a low-ash, qualitative paper having a basis weight of about 66 grams per square meter (g/m ) and a caliper or thickness of about 7.3 thousandths of an inch (mils).

[0024] The indicator chemical 14 is salicylamide, ethoxy benzomide or a similar chemical, having a colorant added in a concentration of about 0.01 percent by weight. An example of one colorant is a blue color dye.

[0025] The window 12, which is formed in the paper layer 28 and the adhesive layer 30, extends over an area of the surface of the paper layer 28 less than the entirety of the length of the paper 28. Further, the window 12 has a length L ₁₂ and a width Wi2, which are less than the length L ₂ o and the width W ₂ o of the wicking element 20. The window 12 is arranged over the wicking element 20, such that only a portion of the wicking element 20 is visible through the film layer 26 and the window 12.

[0026] The test strip 10 is configured such that when the test strip 10 is inserted in the specimen holder 100 and placed in a pre-vacuum type sterilizer chamber, the test strip 10 can indicate whether adequate air removal has occurred during a sterilization cycle, which provides saturated steam at 134°C for 3.5min ± 5 sec and/or at 121°C for 15min ± 5 sec, as does a Bowie-Dick-type test indicator system prepared according to ANSI/AAMI/ISO 11140-5:2007. During a sterilization cycle, the indicator chemical 14 liquefies and wicks along the wicking material 20. In preferred embodiments, adequate air removal is verified when the liquefied indicator chemical wicks passed the window 12. That is, the color of the liquefied indicator chemical, for example, blue, must cover substantially the entire portion of the wicking material 20 visible through the window 12 to indicate that air has been adequately removed from the sterilizer chamber during a pre-vacuum sterilizing cycle.

Therefore, the window 12 is sized and arranged at a precalculated distance from the location of the indicator chemical 14 according to particular pre-vacuum steam sterilization parameters.

[0027] In one embodiment, the test strip 10 has a length L ₁₆ of about 4 inches and a width W ₁₆ of about 3/4 inches. The wicking element 20 has a length L ₂ o of about 3 3/8 inches and a width Wi ₆ of about 1/4 inches, and arranged generally in the middle of the base element 16 as shown in FIG. 3. The indicator chemical 14 is placed under the end portion 32 of the wicking element 20 as shown in FIG. 2. The window 12 has a length L ₁₂ of about 1 inches and a width W ₁₂ of about 3/16 inches, and is arranged longitudinally away from the indicator chemical 14. In this embodiment, the window 12 is positioned away from an end 34 of the wicking element 20 a distance L36 of about 15/16 inches. The window 12 is arranged over the wicking element 20, such that the wicking of the liquefied indicator chemical 14 can be observed through the window 12. In this embodiment, adequate air removal during a steam sterilization cycle is verified when the color change or a dark bar formed from the wicking of the liquefied indicator chemical covers substantially the entire area of the wicking element 20 visible through the window 12.

[0028] Various embodiments of the strip 10 can be configured to work with reusable specimen holders, such as sterilization challenge specimen holders disclosed in US 7,718,125, US 7,740,802, US 7,790,105, and US 7,811,516, the entire contents of which are incorporated herein by reference. An exemplary specimen holder 100 is shown in FIGS. 4-5. The holder 100 includes a hollow tubular body 102, a closure cap 104 and an end plug 106. The body 102 can be covered or enveloped in an insulating layer (not shown.)

[0029] The body 102 includes an internal thread 120 at one open end

122. The closure cap 104 includes a gripping portion 124 and a depending plug 126 having an external thread 128 (to mate to the threaded 120 opening) to close the holder 100. A seal 130 such as the illustrated O-ring can fitted onto the cap 104 to provide a gas-tight seal between the closure cap 104 and the body 102. In a present holder 100, the gripping portion 124 is textured or knurled (as indicated at 132) to facilitate rotating or turning the cap 104. The gripping portion 124 can include a flattened portion (a flat 134) so that when the holder 100 is laid on its side, it will be prevented from rolling.

[0030] The end plug 106 provides a single ingress and egress flow path into and out of the interior or chamber 136 when the cap 104 is in place on the body 102 and permits drawing a vacuum in the holder 100 and introducing a sterilization fluid, such as steam, into to the holder 100 in a controlled manner. The plug 106 includes a body 138 having a recess or well 140 formed therein that defines an inner wall 142. The body 138 includes a spiral formed channel or groove 144 in an outer wall 146 thereof. The outer wall 146 includes a peripheral recess or channel 148 formed adjacent to a sealing lip 150 at an end 152 of the plug 106.

[0031] The spiral formed channel 144 opens at a first end 152 into the peripheral recess 148 and spirals around the body 138 extending to about the opposite end 156 of the plug 106. In a present plug 106, the opposite end 156 (which is the end at the chamber 136 side of the plug 106), includes a chamfer 158 at which the spiral formed groove 144 ends. In a present plug 106, the transition from the peripheral channel 148 to the grooved region 145 is also chamfered as indicated at 160.

[0032] The plug 106 includes an opening 162 through the wall 146 at the peripheral recess 148. The opening 162 provides communication between outside of the holder 100 (the environs E) and the interior or chamber 136 of the holder 100. Communication is provided from the environs E, through the opening 162, into the recess 148, through the spiral groovel44 and into the chamber 136. The chamfers 158, 160 at both ends of the spiral groove 144 (or grooved region 145) provide for a smooth transition into and out of the groove 144 and prevent excessive resistance to flow through the groove 144. The groove 144, is smooth, as by being formed by machining, but provides a tortuous ingress and egress path between the environs E and the chamber 136.

[0033] The plug 106 is friction fitted into the chamber body 102. In this manner the lip 150 is snug up to the interior wall 137 of the body 102 and provides an external seal between the environs E and the peripheral recess 148.

Moreover the plug body outer wall 146, at the grooved region 145 (between the chamfers 158, 160) also is snug up to the interior wall 137 of the body 102 and provides a seal between the recess 148 and the chamber 136 and the groove 144. It will be appreciated that the interior wall 137 of the body, at the plug 106 is smooth, unlike the threads 120 formed in the cap 104 end. In that there is no machining necessary at interior wall 137 the smooth surface (unlike threads) proper "mating" of the plug 106 and body 102 is enhanced.

[0034] A present holder 100 is formed from aluminum. Many different materials are contemplated for use, including various other metals, steels, alloys and the like. Suitable polymers may also be used, as will be appreciated by those skilled in the art. Due to the thermal conditions to which the holder 100 is subjected, each of the parts of the present holder 100 (the body 102, the cap 104 and the plug 106) is preferably formed from a similar material. This is to prevent the parts from expanding and contracting at different rates, and in different proportions from one another. It is also contemplated that different materials having similar thermal properties can also be used, where appropriate. [0035] It will also be appreciated from the above -provided discussion that the spiral groove 144 must be formed or machined to within a fairly tight tolerance. In a present holder 100, a plug 106 having an overall length of about 1 inch is formed with a groove 144 having a cross-sectional area of 0.00031 inches'. The groove 144 is formed using a 1/16 inch grooving tool having a rounded or curved profile, and cut to a depth of about 0.011 inches ±0.0005 inches (about 1/3 of a circle having a 1/16 inch diameter). The groove 144 has width of about 0.045 inches.

Cross-sectional areas of up to about 0.001 inches can be used, however, the length of the plug 106 (and the spiral groove 144) is formed commensurately longer. For example, in a groove 144 having a cross-sectional area of 0.000553 inches", the groove 144 must be formed in a plug 106 having a length of about 2 inches (compared to a 1 inch plug 106 for the 0.00031 inches area). It has been found that the cross- sectional area of the groove 144 is best formed at less than about 5.5 E-4 inches . The grooves 144 are formed in the plug 106 at a rate (density) of about 10 turns per linear inch of plug 106.

[0036] In use, the test strip 10 is placed in the holder 100 and the holder 100 is placed inside of the sterilizer chamber. The sterilizer chamber is evacuated and steam is then introduced into the device. Following a sterilization cycle, the specimen holder 100 is removed from the sterilizer chamber, and the test strip 10 is checked to verify whether air was adequately evacuated during the sterilization cycle as described before.

[0037] All patents referred to herein, are hereby incorporated herein by reference, whether or not specifically done so within the text of this disclosure.

[0038] In the present disclosure, the words "a" or "an" are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0039] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover all such modifications as fall within the scope of the invention.