Process challenge device and manufacturing method thereof

Abstract

A process challenge device for determining the effectiveness of a sterilization procedure is provided. The process challenge device includes a stack including a plurality of test sheets disposed on top of each other. The process challenge device also includes a test indicator disposed within the plurality of test sheets of the stack and surrounded by the plurality of test sheets. The process challenge device also includes a first flexible sheet including a bottom wall on which the stack is received, a plurality of side walls, and a peripheral flange extending from the plurality of side walls. The process challenge device also includes a second flexible sheet disposed on the stack and the peripheral flange, and at least partially engaged with the stack and the peripheral flange. The process challenge device also includes a continuous peripheral seal that couples the second flexible sheet to the peripheral flange. The stack is fully surrounded by the first flexible sheet and the second flexible sheet.

Description

Technical Field

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

[0002] Sterilization of medical devices and hospital equipment may not be effective until the steam sterilant contacts all surfaces of the sterilized material under the appropriate combination of time, temperature and steam quality. In steam sterilizers (such as pre-vacuum steam sterilizers and gravity displacement steam sterilizers), the sterilization process is carried out in three main stages. In the first stage, air (including air trapped in any porous material being processed) is removed. Therefore, the first stage is the air removal stage. The second stage is the sterilization stage, in which the load (i.e., the product being sterilized) is subjected to steam treatment under pressure for a recognized, predetermined time and temperature combination to achieve sterilization. The third stage is the drying stage, in which condensate formed during the first two stages is removed by evacuating the chamber.

[0003] Any air that is not removed from the sterilizer during the air removal phase of the cycle or any air that leaks into the sterilizer during the pressure phase below atmospheric pressure due to, for example, defective gaskets, valves or seals can form air pockets in any porous material present. Such air pockets can form a barrier to steam penetration, thereby preventing sufficient sterilization conditions from being achieved on all surfaces of the load during the sterilization phase. For example, these air pockets can prevent steam from reaching the inner layer of the material, such as hospital linens or fabrics. In some other examples, these air pockets can prevent steam from penetrating the hollow spaces of tubes, catheters and syringe needles, etc. In addition, non-condensable gases (usually air) present in the sterilizer are poor sterilants and may reduce sterilization efficacy. The percentage of non-condensable gases in steam should be less than or equal to 3.5% by volume. Therefore, the presence of air pockets and / or non-condensable gases may affect the steam quality of the steam sterilant. Therefore, due to reduced steam quality, suitable sterilization may not occur. Other factors that may affect steam quality include insufficient steam supply, water quality, degassing, design of the sterilizer chamber, etc.

[0004] It can be said that due to improper steam quality, air removal, sterilization time and temperature, proper sterilization may not occur. In order to monitor whether the sterilization process is carried out at the appropriate temperature, with the appropriate steam quality, air removal and in the appropriate time period, a process interrogation device and / or a Bowie-Dick test device are used. The process interrogation device can be used to evaluate steam parameters such as steam quality, temperature and time of the sterilization procedure. The Bowie-Dick test device is more focused on monitoring the air removal inside the sterilizer chamber. Summary of the invention

[0005] In a first aspect, the present disclosure provides a process query device for determining the effectiveness of a sterilization procedure. The process query device includes a stack including a plurality of test sheets disposed on top of each other. The stack also includes an outer surface. The process query device also includes a test indicator disposed within the plurality of test sheets of the stack and surrounded by the plurality of test sheets. The process query device also includes a first flexible sheet that conforms at least partially to the outer surface of the stack. The first flexible sheet includes a bottom wall on which the stack is received, a plurality of side walls extending from the bottom wall, and a peripheral flange extending from the plurality of side walls and substantially parallel to the bottom wall. The bottom wall of the first flexible sheet and the plurality of side walls together define a sheet cavity therebetween. The sheet cavity receives the stack therein and is sized so that each of the plurality of side walls at least partially engages with the stack. The angle of inclination between each of the plurality of side walls and the bottom wall is 80 to 100 degrees. The process interrogation device also includes a second flexible sheet material disposed on the stack and the peripheral flange of the first flexible sheet and at least partially engaged with the stack and the peripheral flange of the first flexible sheet. The second flexible sheet material covers the stack. The process interrogation device also includes a continuous peripheral seal member that couples the second flexible sheet material to the peripheral flange so that the stack is completely surrounded by the first flexible sheet material and the second flexible sheet material.

[0006] In a second aspect, the present disclosure provides a method for manufacturing a process query device for determining the effectiveness of a sterilization procedure. The method includes: providing a stack, the stack includes a plurality of test sheets arranged on top of each other. The stack also includes an outer surface. The method also includes: placing a test indicator in the plurality of test sheets of the stack. The method also includes: placing the stack on a first flexible sheet. The method also includes: placing the first flexible sheet together with the stack in a frame-shaped object, the frame-shaped object including a frame-shaped object bottom wall, a plurality of frame-shaped object side walls extending from the frame-shaped object bottom wall, a frame-shaped object peripheral flange extending from the plurality of frame-shaped object side walls and substantially parallel to the frame-shaped object bottom wall, and a frame-shaped object cavity defined between the frame-shaped object bottom wall and the plurality of frame-shaped object side walls. The frame-shaped object cavity at least partially receives the first flexible sheet together with the stack therein. Placing the first flexible sheet together with the stack in the frame-shaped object deforms the first flexible sheet to conform to the outer surface of the stack at least partially. The deformation of the first flexible sheet material forms a bottom wall that is at least partially engaged with the bottom wall of the frame-shaped object, a plurality of side walls that extend from the bottom wall and at least partially engage with the corresponding multiple frame-shaped object side walls, and a peripheral flange that extends from the multiple side walls and is substantially parallel to the bottom wall. The peripheral flange of the first flexible sheet material is at least partially engaged with the frame-shaped object peripheral flange. The size of the frame-shaped object cavity is set so that each side wall in the multiple side walls of the first flexible sheet material is at least partially engaged with the stacking body. In addition, the size of the frame-shaped object cavity is set so that the angle of inclination between each side wall in the multiple side walls and the bottom wall of the first flexible sheet material is 80 degrees to 100 degrees. The method also includes: the second flexible sheet material is placed on the stacking body and the first flexible sheet material, so that the second flexible sheet material covers the stacking body, and at least partially engages with the peripheral flange of the stacking body and the first flexible sheet material. The method also includes: forming a continuous peripheral seal between the second flexible sheet and the peripheral flange, thereby connecting the second flexible sheet to the peripheral flange and completely enclosing the stack between the first flexible sheet and the second flexible sheet. The method also includes: removing the first flexible sheet together with the stack from the frame. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The exemplary embodiments disclosed herein may be more completely understood by considering the following detailed description in conjunction with the following drawings. The drawings are not necessarily drawn to scale. The same numerals used in the drawings represent similar components. However, it should be understood that the use of numbers to refer to components in a given figure is not intended to limit the components marked with the same number in another figure.

[0008] Figure 1 is a perspective view of a process challenge device for determining the effectiveness of a sterilization procedure according to one embodiment of the present disclosure;

[0009] Figure 2 According to one embodiment of the present disclosure Figure 1 An exploded view of a stack of process challenge devices, a test indicator and a first flexible sheet;

[0010] Figure 3 According to one embodiment of the present disclosure Figure 1 An exploded view of the stack of process query devices and the first flexible sheet and frame-shaped object;

[0011] Figure 4 According to one embodiment of the present disclosure Figure 1 A perspective view of a stack of a process interrogation device and a first flexible sheet and a frame-shaped object, wherein the first flexible sheet together with the stack is placed in the frame-shaped object;

[0012] Figure 5 is a perspective view of a first flexible sheet after being placed within a frame-shaped object according to one embodiment of the present disclosure;

[0013] Figure 6 According to one embodiment of the present disclosure Figure 4 A stacked body, a first flexible sheet and a frame-shaped object and Figure 1 A perspective view of a process interrogation device of a combination of a second flexible sheet placed on a stack and a first flexible sheet;

[0014] Figure 7 According to one embodiment of the present disclosure Figure 6 A perspective view of a combination of a first flexible sheet, a second flexible sheet and a frame-shaped object, and a sealing plate placed on the second flexible sheet;

[0015] Figure 8 According to one embodiment of the present disclosure Figure 7 A perspective view of a first flexible sheet, a second flexible sheet, a frame-shaped object, and a sealing plate, wherein the first flexible sheet and the second flexible sheet are shown to be at least partially received between the frame-shaped object and the sealing plate;

[0016] Fig. 9 According to one embodiment of the present disclosure Figure 1 Process query device, Figure 3 The frame and Figure 7 A perspective view of a sealing plate of FIG. 1 , wherein the frame and sealing plate are shown removed from the process interrogation device;

[0017] Fig.10 is a perspective view of a frame-shaped object according to another embodiment of the present disclosure;

[0018] Fig.11 is a perspective view of a frame according to yet another embodiment of the present disclosure; and

[0019] Fig.12 is manufactured according to one embodiment of the present disclosure Figure 1 A flow chart of a method of querying a device in the process. DETAILED DESCRIPTION

[0020] In the following description, reference is made to the accompanying drawings which form a part thereof, and in which various embodiments are shown by way of illustration. It should be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. Therefore, the following detailed description should not be construed in a limiting sense.

[0021] As used herein, all numbers should be considered to be modified by the term “about.” As used herein, “a,” “an,” “the,” “at least one,” and “one or more” are used interchangeably.

[0022] As used herein as a modifier of a property or attribute, unless otherwise specifically defined, the term "substantially" means that the property or attribute would be readily recognized by a skilled artisan but does not require absolute precision or a perfect match (e.g., within + / - 20% for a quantifiable property).

[0023] Unless specifically defined otherwise, the term "substantially" means a high degree of approximation (eg, within + / - 10% for a quantifiable property), but likewise does not require absolute precision or a perfect match.

[0024] As used herein, the term "sheet" generally refers to a material having a very high ratio of length or width to thickness. A sheet has two major surfaces defined by a length and a width. Sheets generally have good flexibility and can be used in a variety of applications, including displays. Sheets may also have a thickness or material composition such that they are semi-rigid or rigid. The sheets described in the present disclosure may be composed of various polymeric materials. The sheets may be a single layer, a multilayer, or a blend of different polymers.

[0025] The term "coupled" or "connected" may include a direct physical connection between two or more components, or an indirect physical connection between two or more components connected together through one or more additional components. For example, a first component may be coupled to a second component by being directly connected together or by being connected through a third component.

[0026] The term "non-thermoformable" refers to a sheet that cannot be formed or thermoformed into a desired shape by applying a pressure differential between the sheet and a mold, by applying heat, by a combination of applying heat and applying a pressure differential between the sheet and a mold, or by any thermoforming technique known to those skilled in the art.

[0027] The term "non-moldable" may mean that the member is not easily plastically deformed during use compared to a moldable member.

[0028] Steam sterilizers are widely used in medical centers and hospitals to sterilize medical devices. Frequent testing or monitoring of steam quality may be necessary to ensure the safe use of medical devices in medical treatment. In other words, before subjecting a given load (i.e., medical device) to steam, routine testing may be necessary to check the effectiveness of air removal during the air removal phase of the sterilization procedure. One of the ways to monitor the steam quality of a steam sterilant is the Bowie-Dick test. Generally speaking, the Bowie-Dick test uses an indicator disposed between multiple sheets of paper to form a test pack. In some cases, the indicator is a chemical indicator. In some cases, the indicator is a biological indicator. In some cases, the test pack used in the Bowie-Dick test includes a disposable test pack.

[0029] Typically, the test pack is packaged or placed in a wrapper so that the package can present resistance to various flow paths leading to hidden spaces such as tubes, catheters, and syringe needles (i.e., resistance to steam sterilizers). Conventionally, the test pack is packaged in a wrapper by manually folding various portions of the wrapper. In other words, the user must manually fold the wrapper multiple times to completely stack multiple paper sheets and stack indicators. Such a process may be tedious and time-consuming for the user. In addition, such a process may also fail to provide accurate wrapping of the test pack. In some applications, a machine may be used to avoid manual folding. However, such a machine may increase the cost and complexity of the entire folding process. During the handling of the wrapper, there may also be the possibility of the wrapper separating or unfolding.

[0030] The present disclosure relates to a process query device for determining the effectiveness of a sterilization procedure. The process query device includes a stack including a plurality of test sheets disposed on top of each other. The stack also includes an outer surface. The process query device also includes a test indicator disposed within the plurality of test sheets of the stack and surrounded by the plurality of test sheets. The process query device also includes a first flexible sheet that conforms at least partially to the outer surface of the stack. The first flexible sheet includes a bottom wall on which the stack is received, a plurality of side walls extending from the bottom wall, and a peripheral flange extending from the plurality of side walls and substantially parallel to the bottom wall. The bottom wall of the first flexible sheet and the plurality of side walls together define a sheet cavity therebetween. The sheet cavity receives the stack therein and is sized so that each of the plurality of side walls at least partially engages with the stack. The angle of inclination between each of the plurality of side walls and the bottom wall is 80 to 100 degrees. The process interrogation device also includes a second flexible sheet material disposed on the stack and the peripheral flange of the first flexible sheet and at least partially engaged with the stack and the peripheral flange of the first flexible sheet. The second flexible sheet material covers the stack. The process interrogation device also includes a continuous peripheral seal member that couples the second flexible sheet material to the peripheral flange so that the stack is completely surrounded by the first flexible sheet material and the second flexible sheet material.

[0031] By coupling the second flexible sheet to the peripheral flange of the first flexible sheet via the continuous peripheral seal, the stack including the test indicator is securely stacked within the second flexible sheet and the first flexible sheet. In addition, the continuous peripheral seal facilitates stacking of the stack within the second flexible sheet and the first flexible sheet without the need to manually fold the second flexible sheet and the first flexible sheet.

[0032] Since each of the plurality of side walls is at least partially engaged with the stack and the inclination angle between each of the plurality of side walls and the bottom wall is 80 to 100 degrees, a desired packing density of the stack can be achieved. In some embodiments, the stack comprises from 0.55 g / cm 3 Up to 0.75g / cm 3 Such a packing density of the stack can keep the stack including the test indicator intact within the second flexible sheet and the first flexible sheet, which can ultimately improve the accuracy of the Bowie-Dick test results. Therefore, the process challenge device can accurately determine the effectiveness of the sterilization procedure.

[0033] The present disclosure also relates to a method for manufacturing a process query device for determining the effectiveness of a sterilization procedure. The method includes: providing a stack, the stack includes a plurality of test sheets arranged on top of each other. The stack also includes an outer surface. The method also includes: placing a test indicator in the plurality of test sheets of the stack. The method also includes: placing the stack on a first flexible sheet. The method also includes: placing the first flexible sheet together with the stack in a frame-shaped object, the frame including a frame bottom wall, a plurality of frame side walls extending from the frame bottom wall, a frame peripheral flange extending from the plurality of frame side walls and substantially parallel to the frame bottom wall, and a frame cavity defined between the frame bottom wall and the plurality of frame side walls. The frame cavity at least partially receives the first flexible sheet together with the stack therein. Placing the first flexible sheet together with the stack in the frame deforms the first flexible sheet to conform to the outer shape of the stack at least partially. The deformation of the first flexible sheet material forms a bottom wall that is at least partially engaged with the bottom wall of the frame-shaped object, a plurality of side walls that extend from the bottom wall and at least partially engage with the corresponding multiple frame-shaped object side walls, and a peripheral flange that extends from the multiple side walls and is substantially parallel to the bottom wall. The peripheral flange of the first flexible sheet material is at least partially engaged with the frame-shaped object peripheral flange. The size of the frame-shaped object cavity is set so that each side wall in the multiple side walls of the first flexible sheet material is at least partially engaged with the stacking body. In addition, the size of the frame-shaped object cavity is set so that the angle of inclination between each side wall in the multiple side walls and the bottom wall of the first flexible sheet material is 80 degrees to 100 degrees. The method also includes: the second flexible sheet material is placed on the stacking body and the first flexible sheet material, so that the second flexible sheet material covers the stacking body, and at least partially engages with the peripheral flange of the stacking body and the first flexible sheet material. The method also includes: forming a continuous peripheral seal between the second flexible sheet and the peripheral flange, thereby connecting the second flexible sheet to the peripheral flange and completely enclosing the stack between the first flexible sheet and the second flexible sheet. The method also includes: removing the first flexible sheet together with the stack from the frame.

[0034] The frame is designed so that the inclination angle between each of the plurality of side walls and the bottom wall of the first flexible sheet is 80 to 100 degrees. In addition, since the first flexible sheet is placed in the frame together with the stack, each of the plurality of side walls of the first flexible sheet is at least partially engaged with the stack. This can provide a desired bulk density (e.g., from 0.55 g / cm 3 Up to 0.75g / cm 3Therefore, the proposed manufacturing method can keep the stack including the test indicator intact within the second flexible sheet and the first flexible sheet, which can ultimately improve the accuracy of the Bowie-Dick test result.

[0035] Furthermore, the proposed method of manufacturing the process challenge device does not involve any manual steps of folding the first flexible sheet and / or the second flexible sheet. Therefore, when manufacturing the process challenge device by the proposed method, any errors associated with manual folding of sheets or wrappings are avoided. Furthermore, the proposed method of manufacturing the process challenge device may be easy to perform and may be cost-effective compared to conventional techniques and methods of manufacturing the process challenge device.

[0036] Now referring to the accompanying drawings, Figure 1 is a perspective view of a process challenge device 100 for determining the effectiveness of a sterilization procedure according to one embodiment of the present disclosure. The process challenge device 100 is used to perform a Bowie-Dick test and provides a resistance to a steam sterilant that is substantially the same as the resistance of various flow paths leading to hidden spaces of tubes, catheters, syringe needles, etc.

[0037] The process query device 100 includes a stack 102 (in Figure 2 ), a test indicator 104 and a first flexible sheet 106. Figure 2 According to one embodiment of the present disclosure Figure 1 An exploded view of the stack 102, the test indicator 104 and the first flexible sheet 106 of the process challenge device 100. Figure 2 In the embodiment, for illustrative purposes, the first flexible sheet 106 is shown in an undeformed state. Figure 1 In the process query device 100, the first flexible sheet 106 is in a deformed state. In the illustrated embodiment, the first flexible sheet 106 has a rectangular shape in an undeformed state.

[0038] refer to Figure 1 and Figure 2, stack 102 includes a plurality of test sheets 108 disposed on top of each other. In some embodiments, each of the plurality of test sheets 108 is made of paper, or of paper and polyurethane foam. The presence of polyurethane foam in the paper can help keep the plurality of test sheets 108 with a desired pressure. Each of the plurality of test sheets 108 can be made of porous paper. Therefore, the plurality of test sheets 108 are permeable to the steam sterilizer used in the sterilization procedure and to gas (e.g., ethylene oxide). Stack 102 also includes an outer surface 105. The outer surface 108 of stack 102 is defined by a pair of outer (i.e., top and bottom) test sheets 108 of stack 102 and the combined thickness of the plurality of test sheets 108 when stacked on top of each other. In the illustrated embodiment, the outer surface 108 has a substantially cubic shape because the test sheets 108 are rectangular.

[0039] The test indicator 104 is disposed within and surrounded by a plurality of test sheets 108 of the stack 102. At least some of the plurality of test sheets 108 adjacent to the test indicator 104 may be deformed to surround the test indicator 104 within the stack 102. The test indicator 104 may be a biological indicator or a chemical indicator. In some embodiments, there may be two or more test indicators 104 disposed within and surrounded by the plurality of test sheets 108. The test indicator 104 may be selected for use with the sterilization conditions employed in a particular sterilization procedure. In addition, the test indicator 104 may be selected based on the amount of exposure to the sterilization conditions required for the test indicator 104 to indicate that exposure has occurred. Thus, the selection of the test indicator 104 may be used to increase or decrease the resistance of the process challenge device 100. To manufacture the process challenge device 100, the test indicator 104 is placed within a plurality of test sheets 108 of the stack 102, such as Figure 2 shown.

[0040] In the process of querying the device 100 (in Figure 1 ), the first flexible sheet 106 at least partially conforms to the outer surface 105 of the stack 102. To manufacture the process challenge device 100, once the test indicator 104 is placed within the plurality of test sheets 108 of the stack 102, the stack 102 is placed on the first flexible sheet 106 (in an undeformed state), as shown in FIG. Figure 2 shown.

[0041] Figure 3 According to one embodiment of the present disclosure Figure 1100 and the frame 110. The frame 110 may be a rigid metal member. To manufacture the process query device 100, once the stack 102 is placed on the first flexible sheet 106 (in an undeformed state, Figure 2 As shown in FIG. 1 ), the first flexible sheet 106 together with the stack 102 is placed in the frame 110. Figure 4 According to one embodiment of the present disclosure Figure 1 FIG. 1 is a perspective view of a stack 102 and a first flexible sheet 106 and a frame 110 of a process query device, wherein the first flexible sheet 106 together with the stack 102 is placed in the frame 110 .

[0042] refer to Figure 3 and Figure 4 , frame 110 comprises frame bottom wall 112, a plurality of frame side walls 114 extending from frame bottom wall 112 and a frame perimeter flange 116 extending from a plurality of frame side walls 114 and substantially parallel to frame bottom wall 112.Frame 110 also comprises a frame cavity 118 defined between frame bottom wall 112 and a plurality of frame side walls 114.In the illustrated embodiment, frame bottom wall 112 and a plurality of frame side walls 114 are rectangular.The quantity of frame side walls 114 is four.In addition, frame cavity 118 has a cubic shape.In addition, frame perimeter flange 116 has a rectangular inner edge and an outer edge.

[0043] When the first flexible sheet 106 is placed in the frame 110 with the stack 102, the frame cavity 118 at least partially receives the first flexible sheet 106 in the frame 110 with the stack 102. In addition, placing the first flexible sheet 106 in the frame 110 with the stack 102 deforms the first flexible sheet 106 to at least partially conform to the outer surface 105 of the stack 102. Figure 5 is a perspective view of the first flexible sheet 106 after being placed within the frame 110 according to one embodiment of the present disclosure. In other words, Figure 5 is a perspective view of the first flexible sheet 106 in a deformed state.

[0044] refer to Figures 3 to 5 After the first flexible sheet 106 is deformed, the first flexible sheet 106 includes: a bottom wall 120 (in Figure 5), the bottom wall receiving the stack 102 thereon; a plurality of side walls 122 extending from the bottom wall 120; and a peripheral flange 124 extending from the plurality of side walls 122 and substantially parallel to the bottom wall 120. In other words, after the first flexible sheet 106 is deformed, the bottom wall 120 of the first flexible sheet 106 is formed, which is at least partially engaged with the frame-shaped bottom wall 112. In addition, after the first flexible sheet 106 is deformed, the plurality of side walls 122 of the first flexible sheet 106 are formed, which are at least partially engaged with the corresponding plurality of frame-shaped side walls 114. In addition, after the first flexible sheet 106 is deformed, the peripheral flange 124 of the first flexible sheet 106 is formed, which is at least partially engaged with the frame-shaped peripheral flange 116.

[0045] The bottom wall 120 and the plurality of side walls 122 of the first flexible sheet 106 together define a sheet cavity 126 therebetween. The sheet cavity 126 receives the stack 102 therein, and its size is set so that each of the plurality of side walls 122 is at least partially engaged with the stack 102. Specifically, the size of the frame-shaped cavity 118 is set so that each of the plurality of side walls 122 of the first flexible sheet 106 is at least partially engaged with the stack 102. In addition, the size of the frame-shaped cavity 118 is set so that the inclination angle α between each of the plurality of side walls 122 and the bottom wall 120 of the first flexible sheet 106 is 80 to 100 degrees. Such values ​​of the inclination angle α between each of the plurality of side walls 122 of the first flexible sheet 106 and the bottom wall 120 can help the stack 102 obtain a desired packing density, which will be discussed later in the specification. In some embodiments, the inclination angle α can be about 90 degrees.

[0046] In the illustrated embodiment, the bottom wall 120 and the plurality of side walls 122 of the first flexible sheet 106 are rectangular. The number of the side walls 122 is four. In addition, the sheet cavity 126 has a cubic shape. In addition, the peripheral flange 124 has a rectangular inner edge and an outer edge.

[0047] Reference again Figure 1 The process query device 100 further includes a second flexible sheet 128, which is disposed on the stack 102 (in Figure 3 The second flexible sheet 128 covers the stack 102. In the illustrated embodiment, the second flexible sheet 128 is rectangular. Figure 6 According to one embodiment of the present disclosure Figure 4 The stack 102, the first flexible sheet 106 and the frame 110 and Figure 1FIG. 1 is a perspective view of the process challenge device 100 of the combination of the second flexible sheet 128 placed on the stack 102 and the first flexible sheet 106 .

[0048] To manufacture the process challenge device 100, once the first flexible sheet 106 is placed within the frame 110 together with the stack 102, the second flexible sheet 128 is placed over the stack 102 and the first flexible sheet 106 so that the second flexible sheet 128 covers the stack 102 and is at least partially engaged with the peripheral flange 124 of the stack 102 and the first flexible sheet 106.

[0049] In some embodiments, each of the first flexible sheet 106 and the second flexible sheet 128 has no area greater than or equal to 0.5 mm 2 . This prevents any unrestricted and uneven flow of steam sterilant through the first flexible sheet 106 and the second flexible sheet 128. Any unrestricted and uneven flow of steam sterilant may damage any test results provided by the process query device 100. In some embodiments, each of the first flexible sheet 106 and the second flexible sheet 128 is non-thermoformable and non-moldable. Therefore, each of the first flexible sheet 106 and the second flexible sheet 128 may not be formed or thermoformed into a desired shape by applying a pressure difference between the corresponding flexible sheet and the mold, by applying heat, by applying heat and applying a pressure difference between the corresponding flexible sheet and the mold, or by any thermoforming technology known to those skilled in the art. In addition, each of the first flexible sheet 106 and the second flexible sheet 128 may not be easily plastically deformed when used. In some embodiments, each of the first flexible sheet 106 and the second flexible sheet 128 is permeable to the steam sterilant used in the sterilization procedure and to gases (such as ethylene oxide).

[0050] In some embodiments, each of the first flexible sheet 106 and the second flexible sheet 128 is made of nonwoven material.Nonwoven material means a fabric or fiber web having a structure of a single fiber or thread, which is interwoven in a manner that is not identifiable as in a knitted fabric.Nonwoven fabrics or fiber webs have been formed by many processes (such as, for example, meltblown processes, spunbond processes, and bonded carded fiber web processes).In some embodiments, the nonwoven material includes a three-layer spunbond-meltblown-spunbond (SMS) structure.In the SMS structure of the nonwoven material, the outermost layer of the SMS structure provides mechanical protection for the internal contents, and the middle layer is primarily responsible for microbial filtration.In some embodiments, the nonwoven material includes at least a portion of polyolefin fibers (i.e., polypropylene or polyethylene).The permeability of the nonwoven material can be in the range of about 15 cubic feet per minute (CFM) to about 500 CFM.

[0051] Reference again Figure 1 The process interrogation device 100 also includes a continuous peripheral seal 130 that couples the second flexible sheet 128 to the peripheral flange 124 of the first flexible sheet 106 so that the stack 102 (at Figure 3 106 and the first flexible sheet 106 are completely surrounded by the first flexible sheet 106 and the second flexible sheet 106. In some embodiments, the continuous peripheral seal 130 is a heat seal. The peripheral flange 124 of the second flexible sheet 128 and the first flexible sheet 106 can be heat-sealed together using a heat sealing device (e.g., a heat sealer). In some embodiments, the continuous peripheral seal 130 is an ultrasonic seal. The peripheral flange 124 of the second flexible sheet 128 and the first flexible sheet 106 can be ultrasonically sealed together using an ultrasonic sealing device (e.g., an ultrasonic sealer). The continuous peripheral seal 130 helps to stack the stack 102 as desired within the second flexible sheet 128 and the first flexible sheet 106 without the need to manually fold the second flexible sheet 128 and the first flexible sheet 106.

[0052] In some embodiments, in order to form a continuous peripheral seal 130 between the second flexible sheet 128 and the peripheral flange 124 of the first flexible sheet 106, each of the first flexible sheet 106 and the second flexible sheet 128 has a melting temperature (sealing temperature) greater than 130° C. and less than 220° C. However, in some embodiments, each of the first flexible sheet 106 and the second flexible sheet 128 may also have a melting temperature of about 110° C. or about 240° C.

[0053] After forming the continuous perimeter seal 130 to couple the second flexible sheet 128 to the perimeter flange 124 of the first flexible sheet 106, the stack 102 includes from 0.55 g / cm 3 Up to 0.75g / cm 3 In some embodiments, stack 102 comprises a bulk density of about 0.63 g / cm 3 Such a packing density of the stack 102 can keep the stack 102 including the test indicator 104 intact within the second flexible sheet 128 and the first flexible sheet 106, which can ultimately improve the accuracy of the Bowie-Dick test results. Therefore, the process challenge device 100 can accurately determine the effectiveness of the sterilization procedure.

[0054] In some embodiments, the first flexible sheet 106 further includes a first tab 132 disposed adjacent to the continuous perimeter seal 130 and not sealed to the second flexible sheet 128. The first tab 132 is formed by bending one of the edges of the first flexible sheet 106 prior to forming the continuous perimeter seal 130. The second flexible sheet 128 includes a second tab 134 disposed adjacent to the continuous perimeter seal 130 and not sealed to the first flexible sheet 106. The second tab 134 is formed by bending a corresponding edge of the second flexible sheet 128 prior to forming the continuous perimeter seal 130. Additionally, the first tab 132 and the second tab 134 are not sealed to each other.

[0055] After the sterilization process is completed, the operator can pull the first tab 132 and the second tab 134 to unseal the first flexible sheet 106 and the second flexible sheet 128, thereby accessing the test indicator 104 to evaluate the results of the Bowie-Dick test. Therefore, including the first tab 132 and the second tab 134 can make the process of opening the process challenge device 100 easier.

[0056] Figure 7 According to one embodiment of the present disclosure Figure 6 A perspective view of a combination of a first flexible sheet 106, a second flexible sheet 128, and a frame 110 and a sealing plate 136 placed on the second flexible sheet 128. In some embodiments, a continuous perimeter seal 130 is formed by using a sealing plate 136 (in Figure 1 Specifically, the second flexible sheet 128 and the peripheral flange 124 of the first flexible sheet 106 are at least partially received between the sealing plate 136 and the frame peripheral flange 116. Figure 8 yes Figure 7 106, the second flexible sheet 128, the frame 110, and the sealing plate 136, wherein the first flexible sheet 106 and the second flexible sheet 128 are shown as being at least partially received between the frame 110 and the sealing plate 136. The sealing plate 136 is pressed onto the second flexible sheet 128 and the peripheral flange 124 to form a continuous peripheral seal 130, thereby coupling the first flexible sheet 106 to the second flexible sheet 128.

[0057] After the continuous perimeter seal 130 is formed, the sealing plate 136 and the frame 110 are removed. Fig. 9 is a perspective view of a process challenge device 100 , a frame 110 , and a sealing plate 136 , wherein the frame 110 and the sealing plate 136 are shown removed from the process challenge device 100 , according to one embodiment of the present disclosure.

[0058] Fig.10FIG. 1 is a perspective view of a frame 110 ′ according to an embodiment of the present disclosure. Figure 3 10 is substantially similar and functionally equivalent to the frame 110 shown in , wherein common components are referred to by the same reference numerals. However, the frame 110' has a two-piece construction (rather than the one-piece construction of the frame 110). The two-piece construction of the frame 110' allows the stack 102 and the first flexible sheet 106 to be easily received in the frame cavity 118. In other words, the two-piece construction of the frame 110' can facilitate the first flexible sheet 106 to be inserted into the frame 110' together with the stack 102. In addition, the two-piece construction of the frame 110' can facilitate the frame 110' to be removed from the process query device 100.

[0059] Fig.11 is a perspective view of a frame 110 ″ according to an embodiment of the present disclosure. Figure 3 The frame 110 shown in FIG. 1 is substantially similar and functionally equivalent, wherein common components are designated by the same reference numerals. However, the frame 110 ″ includes a plurality of vacuum channels 138 located therein to facilitate the first flexible sheet 106 (in Figure 3 10 ′ is positioned in the frame cavity 118. The vacuum channel 138 creates a vacuum in the frame cavity 118, thereby improving the positioning of the first flexible sheet 106 and the stack 102 in the frame 110 ′.

[0060] Fig.12 is manufactured according to one embodiment of the present disclosure Figure 1 Flowchart of the method 200 of the process query device 100. Figures 2 to 12 At step 202, the method 200 includes: providing a stack 102 (in Figure 2 and Figure 3 ), the stack includes a plurality of test sheets 108 disposed on top of each other. At step 204, method 200 includes: placing a test indicator 104 (on Figure 2 ) is placed in a plurality of test sheets 108 of the stack 102. At step 206, the method 200 includes: placing the stack 102 on the first flexible sheet 106 (in Figure 3 ).

[0061] At step 208, the method 200 includes placing the first flexible sheet 106 together with the stack 102 in the frame 110 (in Figure 3 and Figure 4). Placing the first flexible sheet 106 together with the stack 102 in the frame 110 deforms the first flexible sheet 106 to at least partially conform to the outer surface 105 of the stack 102. Figure 5 The deformation of the frame (shown in FIG) forms a bottom wall 120 that is at least partially engaged with the frame bottom wall 120, a plurality of side walls 122 that extend from the bottom wall 120 and at least partially engage with the corresponding plurality of frame side walls 114, and a peripheral flange 124 that extends from the plurality of side walls 122 and is substantially parallel to the bottom wall 112.

[0062] At step 210, the method 200 includes: placing the second flexible sheet 128 (at Figure 6 and Figure 7 ) is placed on the stack 102 and the first flexible sheet 106 so that the second flexible sheet 128 covers the stack 102 and is at least partially engaged with the peripheral flange 124 of the stack 102 and the first flexible sheet 106.

[0063] At step 212, the method 200 includes forming a continuous peripheral seal 130 between the second flexible sheet 128 and the peripheral flange 124 (at Figure 1 and Fig. 9 ), thereby coupling the second flexible sheet 128 to the peripheral flange 124 and completely enclosing the stack 102 between the first flexible sheet 106 and the second flexible sheet 128. In some embodiments, the continuous peripheral seal 130 is formed by heat sealing. In some embodiments, the continuous peripheral seal 130 is formed by ultrasonic sealing. In some embodiments, forming the continuous peripheral seal 130 includes: at least partially receiving the second flexible sheet 128 and the sealing plate 136 (in Figure 7 and Figure 8 ) and the peripheral flange 124 between the frame-shaped peripheral flange 116. In some embodiments, forming a continuous peripheral seal 130 provides 0.55g / cm 3 Up to 0.75g / cm 3 The bulk density.

[0064] In some embodiments, the method 200 further includes: using a plurality of vacuum channels 138 (in the Fig.11 ) to position the first flexible sheet 106 in the frame-shaped cavity 118. In some embodiments, the method 200 further includes: bending one of the edges of the first flexible sheet 106 to form a first protrusion 132 (at the Figure 1). The method 200 also includes: bending the corresponding edge of the second flexible sheet 128 to form a second protrusion 134 (at Figure 1 As described above, the first and second tabs 132, 134 are not sealed to each other.

[0065] At step 214, the method 200 further includes removing the first flexible sheet 106 together with the stack 102 from the frame 110, such as Fig. 9 shown.

[0066] Furthermore, compared to techniques for manufacturing conventional process challenge devices, the method 200 of manufacturing the process challenge device 100 of the present disclosure does not involve any manual steps of folding the first flexible sheet 106 and / or the second flexible sheet 128. Therefore, compared to conventional techniques, the proposed method 200 of manufacturing the process challenge device 100 may be easier to perform.

[0067] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.

[0068] Although specific embodiments have been illustrated and described herein, it will be appreciated by those skilled in the art that a variety of alternative and / or equivalent implementations may replace the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptation or variation of the specific embodiments discussed herein. Therefore, the present disclosure is intended to be limited only by the claims and their equivalents.

Claims

1. A process query device for determining the effectiveness of a sterilization procedure, the process query device comprising: a stack comprising a plurality of test sheets disposed on top of each other, the stack further comprising an outer surface; a test indicator, the test indicator being disposed within the plurality of test sheets of the stack and surrounded by the plurality of test sheets; a first flexible sheet material, the first flexible sheet material at least partially conforming to the outer surface of the stack, the first flexible sheet material comprising a bottom wall receiving the stack thereon, a plurality of side walls extending from the bottom wall, and a peripheral flange extending from the plurality of side walls and substantially parallel to the bottom wall, wherein the bottom wall of the first flexible sheet material and the plurality of side walls together define a sheet cavity therebetween, wherein the sheet cavity receives the stack therein and is sized such that each of the plurality of side walls at least partially engages the stack, wherein the angle of inclination between each of the plurality of side walls and the bottom wall is 80 to 100 degrees; a second flexible sheet material, the second flexible sheet material being disposed on the peripheral flange of the stack and the first flexible sheet material and at least partially engaged with the peripheral flange of the stack and the first flexible sheet material, the second flexible sheet material covering the stack; and A continuous peripheral seal couples the second flexible sheet material to the peripheral flange such that the stack is completely surrounded by the first and second flexible sheets.

2. The process challenge device of claim 1, wherein the continuous perimeter seal is a heat seal.

3. The process interrogation device of claim 1, wherein the continuous perimeter seal is an ultrasonic seal.

4. A process interrogation device according to claim 1, wherein the first flexible sheet further includes a first tab, the first tab is disposed adjacent to the continuous peripheral seal and is not sealed to the second flexible sheet, and wherein the second flexible sheet includes a second tab, the second tab is disposed adjacent to the continuous peripheral seal and is not sealed to the first flexible sheet.

5. The process challenge device of claim 1, wherein the stack comprises 0.55 g / cm 3 Up to 0.75g / cm 3 The bulk density.

6. The process challenge device of claim 1, wherein each of the first flexible sheet and the second flexible sheet is made of a nonwoven material.

7. The process challenge device of claim 6, wherein the nonwoven material comprises a three-layer spunbond-meltblown-spunbond (SMS) construction.

8. The process challenge device of claim 6, wherein the nonwoven material comprises at least a portion of polyolefin fibers.

9. The process interrogation device of claim 1, wherein each of the first flexible sheet material and the second flexible sheet material has a melting temperature greater than 130°C and less than 220°C.

10. The process challenge device of claim 1, wherein each of the first flexible sheet material and the second flexible sheet material is permeable to a steam sterilant used in the sterilization procedure and to a gas.

11. The process challenge device of claim 1, wherein each of the plurality of test sheets is made of paper, or paper and polyurethane foam.

12. The process interrogation device of claim 1, wherein each of the first flexible sheet and the second flexible sheet has no area greater than or equal to 0.5 mm 2 any opening.

13. The process challenge device of claim 1, wherein each of the first flexible sheet material and the second flexible sheet material is non-thermoformable and non-moldable.

14. A method of manufacturing a process challenge device for determining the effectiveness of a sterilization procedure, the method comprising: providing a stack comprising a plurality of test sheets disposed on top of each other, the stack further comprising an outer surface; placing a test indicator within the plurality of test sheets in the stack; placing the stack on a first flexible sheet; The first flexible sheet material is placed together with the stacked body in a frame-shaped object, the frame-shaped object comprising a frame-shaped bottom wall, a plurality of frame-shaped side walls extending from the frame-shaped bottom wall, a frame-shaped peripheral flange extending from the plurality of frame-shaped side walls and substantially parallel to the frame-shaped bottom wall, and a frame-shaped object cavity defined between the frame-shaped bottom wall and the plurality of frame-shaped side walls, wherein the frame-shaped cavity at least partially receives the first flexible sheet material together with the stacked body therein, wherein placing the first flexible sheet material together with the stacked body in the frame-shaped object deforms the first flexible sheet material to at least partially conform to the outer surface of the stacked body, wherein the deformation of the first flexible sheet material forms a bottom wall at least partially engaged with the frame-shaped bottom wall, a plurality of side walls extending from the bottom wall and at least partially engaged with corresponding plurality of frame-shaped side walls, and a peripheral flange extending from the plurality of side walls and substantially parallel to the bottom wall, the peripheral flange of the first flexible sheet material at least partially engaging with the frame peripheral flange, wherein the size of the frame-shaped object cavity is set so that: Each of the plurality of side walls of the first flexible sheet is at least partially engaged with the stack; and The inclination angle between each of the plurality of side walls of the first flexible sheet and the bottom wall is 80 degrees to 100 degrees; placing a second flexible sheet material on the stack and the first flexible sheet material so that the second flexible sheet material covers the stack and at least partially engages the peripheral flanges of the stack and the first flexible sheet material; forming a continuous peripheral seal between the second flexible sheet and the peripheral flange, thereby coupling the second flexible sheet to the peripheral flange and completely enclosing the stack between the first flexible sheet and the second flexible sheet; as well as The first flexible sheet together with the stack is removed from the frame.

15. The method of claim 14, wherein the continuous peripheral seal is formed by heat sealing.

16. The method of claim 14, wherein the continuous peripheral seal is formed by ultrasonic sealing.

17. The method of claim 14, wherein forming the continuous perimeter seal comprises at least partially receiving the second flexible sheet material and the perimeter flange between a sealing plate and the frame perimeter flange.

18. The method according to claim 14, further comprising: before forming the continuous perimeter seal, bending one of the edges of the first flexible sheet to form a first tab; as well as before forming the continuous peripheral seal, bending corresponding edges of the second flexible sheet to form a second tab; Wherein the first tab and the second tab are not sealed to each other.

19. The method according to claim 14, further comprising: A plurality of vacuum channels in the frame are used to position the first flexible sheet in the frame cavity.

20. The method of claim 14, wherein forming the continuous perimeter seal provides the stack with a pressure of 0.55 g / cm 3 Up to 0.75g / cm 3 The bulk density.

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