Pouch with frangible seal

Abstract

A wipe sachet has a first compartment containing a first chemical, a second compartment containing a second chemical, and a third compartment containing a dry wipe. A first coupling assembly (a first frangible seal) couples the first compartment to the second compartment and has a closed configuration in which the first compartment is not in communication with the second compartment, and an open configuration in which the first compartment is in communication with the second compartment. A second coupling assembly (a second frangible seal) couples the second compartment to the third compartment and has a closed configuration in which the second compartment is not in communication with the third compartment, and an open configuration in which the second compartment is in communication with the third compartment. When ready for use, the first frangible seal is broken to mix the bleach in the first compartment with the WFI in the second compartment. The user then breaks the second frangible seal to soak the wipe in the third compartment with the bleach / WFI mixture from the first and second compartments.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 62 / 990,220, filed March 16, 2020, and U.S. Provisional Application No. 63 / 077,313, filed September 11, 2020, which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to a wiping kit for deactivation, purification, disinfection, or cleaning in a cleanroom environment, and its preparation and usage methods. Background Technology

[0004] A clean or controlled environment is a space designed, maintained, and controlled to prevent particulate and microbial contamination of products. Clean environments include cleanrooms and clean workspaces (such as hooded workspaces), collectively referred to as cleanrooms. Cleanrooms are typically designed for use in manufacturing facilities and medical research and treatment facilities in the pharmaceutical, biotechnology, and healthcare industries, to name just a few. Sterile cleanroom environments can be classified according to various classification schemes, including the International Organization for Standardization (“ISO”) cleanroom standards, where the highest level of sterilization is ISO 1 cleanroom and normal ambient air (without sterilization) is classified as ISO 9.

[0005] Certain chemical compositions are used in cleanrooms, including, for example, bactericides such as phenol, detergents, quaternary ammonium compounds, peracetic acid, and various sporicidal agents such as peracetic acid, bleach, and hydrogen peroxide. Disinfectants and sporicidal agents are used in cleanrooms to disinfect cleanroom surfaces. In some cleanroom environments, such as those in the healthcare industry, surfaces are exposed to certain hazardous chemicals. In those cases, chemicals are needed to deactivate and decontaminate hazardous chemicals on work surfaces to reduce the occupational exposure risk to technicians and other personnel in the cleanroom, as well as to the products or chemicals being prepared in the cleanroom. Methods for deactivating, decontaminating, and disinfecting / cleaning surfaces exposed to hazardous chemicals must comply with the requirements of the United States Pharmacopeia (USP). <800> and USP <797> The requirements outlined in [the document] are insufficient for this purpose. Conventional cleanroom sterilization methods are inadequate because they do not adequately deactivate hazardous chemicals, but simply disperse the chemicals onto the affected surfaces. Furthermore, products that may be capable of deactivating hazardous chemicals are unsuitable for use in ISO 5-classified cleanrooms.

[0006] Furthermore, non-naturally sterile chemical compositions need to be sterilized before entering the cleanroom to avoid the risk of contamination. Such compositions can be sterilized by filtration within the cleanroom or by sterilization before entering the cleanroom.

[0007] To sterilize the composition outside a cleanroom, the concentrated composition is either final sterilized by irradiation or aseptically processed. For final irradiation sterilization, the composition is placed in a container, double-bagded, and then placed in a lined cardboard box. The entire cardboard box is then final sterilized by irradiation. A procedure for final irradiation sterilization of a composition is described, for example, in U.S. Patent No. 6,123,900 to Vellutato, the disclosure of which is incorporated herein by reference. However, some chemicals used in cleanrooms cannot be irradiated due to their chemical composition and structure. For example, certain chemicals used in cleanrooms to deactivate and purify hazardous drugs cannot be irradiated. This presents problems for introducing such chemicals into the cleanroom environment and complicates the sterilization process.

[0008] Therefore, this invention relates to a deactivation wiping kit that improves the deactivation, purification, and disinfection / cleaning of harmful drugs on sterile surfaces in cleanrooms. The deactivation wiping kit of this invention can also be irradiated outside the cleanroom environment for more efficient transfer and introduction into the cleanroom. Summary of the Invention

[0009] One aspect of the invention is to provide a wiping pouch having a plurality of compartments separated by one or more brittle seals. The wiping pouch may have a first compartment containing dried wiping material, a second compartment having a one-way filling valve connected thereto, and a connecting assembly (e.g., a brittle seal) connecting the first compartment to the second compartment. In a closed configuration, the first compartment is not in communication with the second compartment (e.g., in air or liquid communication). In an open configuration, the first compartment is in communication with the second compartment. Attached Figure Description

[0010] A more thorough understanding of the invention and its many accompanying advantages will readily become apparent when considered in conjunction with the accompanying drawings and by referring to the following detailed description, in which:

[0011] Figure 1 This is a front perspective view of the deactivation wipe kit according to an embodiment of the present invention;

[0012] Figure 2 A front view of the first pouch of a deactivation wiping kit with a one-way valve according to an embodiment of the present invention;

[0013] Figures 3A to 3E for Figure 2 A perspective view of the one-way valve shown;

[0014] Figure 4 A flowchart outlining the steps of a method for preparing a deactivation wiping kit according to an embodiment of the present invention;

[0015] Figure 5 A flowchart outlining the steps of a method using a deactivation wiping kit according to an embodiment of the present invention;

[0016] Figure 6 A perspective view of a pouch according to another embodiment of the present invention, having a sidewall on the longitudinal side between a first pouch layer and a second pouch layer;

[0017] Figure 7 This is a perspective view of a small bag, in which the longitudinal and transverse sides of the first and second bag layers are directly heat-sealed to each other without sidewalls;

[0018] Figure 8 A front view of a pouch according to an embodiment of the present invention, which has three compartments;

[0019] Figure 9 for Figure 8 A front view of the small bag;

[0020] Figure 10 For small bags with three compartments of different sizes;

[0021] Figure 11 for Figure 10 Front sectional view;

[0022] Figure 12 for Figure 10 Side view;

[0023] Figure 13 for Figure 10 Top view;

[0024] Figure 14 It shows Figure 10 Example size; and

[0025] Figure 15 Another embodiment of the invention with two compartments is shown. Detailed Implementation

[0026] Now for reference Figure 1This illustrates a deactivation swab kit 100. As used more fully herein, the term "swab kit" is used to refer to the deactivation swab kit 100. In one embodiment, the swab kit 100 comprises three pouches 102, 104, and 106. Each of these pouches contains a swab impregnated with a different chemical substance used to deactivate and clean hazardous pharmaceuticals and to disinfect work surfaces in a cleanroom environment. In use, a technician applies each swab from each of pouches 102, 104, and 106 sequentially to the contaminated work surface, such that the swab from the first pouch 102 is used first, followed by the swab from the second pouch 104, and finally the swab from the third pouch 106. When used in this manner, the deactivation swab kit 100 deactivates, cleans, and disinfects / cleans most hazardous pharmaceuticals from work environments used for mixing sterile formulations, such as ISO 5 cleanrooms, as proposed by the United States Pharmacopeia (USP). <800> and USP <797> The cited text.

[0027] In one embodiment, the first sachet 102 contains a 5.25% hypochlorite solution, such as sodium hypochlorite (e.g., commercially available from Veltek Associates, Inc. of Malvern, PA). The composition is a wiping agent impregnated in the solution. It is the primary agent for deactivating (one or more) harmful drugs. It deactivates potentially active drugs that may be present on the compounded surface, and makes the surface safe and clean for future use by the handler, and ensures that the compounded formulation complies with the USP for patient protection protocols. <797> USP for the preparation of sterile preparations and for use in hazardous drugs <800> Compliance (handling in a medical setting). While sodium hypochlorite is preferred, any chemical known to deactivate harmful drugs may be used to impregnate the wiping agent in the first pouch 102, including but not limited to potassium permanganate and alkaline potassium permanganate.

[0028] The second small packet 104 contains 2% thiosulfate, such as sodium thiosulfate (e.g., THIO-WIPE, commercially available from Vitec Associates). TMThe wiping agent is impregnated in the solution. In a preferred embodiment, the thiosulfate is USP grade. This composition is used to remove hypochlorite solution residues from treated work surfaces. The thiosulfate neutralizes hypochlorite, a corrosive material, on the surface to maintain its structure and integrity. It also acts as a purifier for the work surface. While sodium thiosulfate is preferred, any known chemical that purifies and neutralizes hypochlorite-treated work surfaces can be used. Therefore, the sodium thiosulfate solution cleans, purifies, and neutralizes the sodium hypochlorite solution and previously deactivated hazardous agents. It improves the overall lifespan of aseptic mixing equipment and maintains compliance with USP standards. <797> and USP <800> .

[0029] The third sachet 106 contains 70% isopropyl alcohol (IPA) (e.g., commercially available from Vitec Associates). The wiping agent, impregnated in the solution, acts as a disinfectant. In a preferred embodiment, the IPA is USP grade. This wiping agent further cleans and disinfects the treated surface and restores it to its original, safe state for workers. While IPA is preferred, any known chemicals for cleaning and disinfecting work surfaces can be used, including but not limited to sterile water or known disinfectants such as phenol, quaternary ammonium compounds, peracetic acid (POAA), and H2O2. Therefore, the IPA provides additional protection against contaminants present on the mixing surface. After deactivating the work surface, additional disinfection is required to maintain the critical, controlled working environment used for mixing sterile products.

[0030] All three chemicals used in each of sachets 102, 104, and 106 are prepared with water for injection (WFI) and filtered through 0.2 microns. Once the surface has been fully treated with all three wipes, it is restored to its natural composition.

[0031] Each of the wipes contained in pouches 102, 104, and 106 is preferably formed of a nonwoven, non-shedding material designed to be clean, have good absorbency, and provide good surface coverage. The wipes should have good non-shedding properties because fibers from the wipes should not easily detach from the wipes to avoid contaminating cleanroom work surfaces. In one embodiment, the wipes in the first pouch 102 are formed of 100% polypropylene, while the wipes in the second pouch 104 and the third pouch 106 are formed of 100% polyester. In this embodiment, the material of each wipe is selected for compatibility with the specific chemicals present in each of pouches 102, 104, and 106. Each of these materials produces a fabric-like wipe that is strong, has good non-shedding particle properties, and is compatible with the chemicals impregnated therein and with use in a controlled environment. In one embodiment, the wipe is about 9” x 12” in size, which allows it to handle a surface area of ​​about six (6) square feet.

[0032] In one embodiment, the wipe in the first pouch 102 is 162XL-4019, No. 48 polyester, which has an ALOX coating bonded to 150 (6 mil) white polyethylene. This particular substrate retains the active hypochlorite but other suitable wipes can be provided. Furthermore, this wipe material minimizes hypochlorite-related degradation and instability caused by exposure to organic materials. In one embodiment, a single wipe is provided in each pouch 102, 104, 106; however, more than one wipe may be provided in any one or all of pouches 102, 104, and 106.

[0033] Pouches 102, 104, and 106 are designed as flexible packaging structures for wiping materials. Pouches 102, 104, and 106 are preferably formed of materials that provide a barrier against moisture, air, and light, and have good chemical resistance to maintain their structural integrity during irradiation and when finally stored in a cleanroom. In one embodiment, each pouch 102, 104, and 106 is formed of a multilayer structure comprising layers of coated polyester, low-density polyethylene, aluminum foil, hydroxypropyl cellulose, and / or linear low-density polyethylene. For example, pouches 102, 104, and 106 may be Glenroy Inc.'s ExpressWeb EFS174, which is attached to this document and incorporated herein by reference. When prepared as a multilayer structure, these materials provide both hermetically and liquid-tight seals and have high chemical resistance (as the stability of the finished product can be affected by light, oxygen, and organic substances). They also help maintain the active agents in each chemical substance, thereby extending their shelf life. Each of sachets 102, 104, and 106 preferably includes a notch or perforation 212, such as Figure 2 As shown, in the first pouch 102, a notch 212 may be formed on the side of pouches 102, 104, and 106, allowing a user to tear open pouches 102, 104, and 106 by pulling on the side of the pouch at the notch 212. Therefore, in use, a technician pulls along the perforation to tear open pouches 102, 104, and 106 to obtain the soaked wipes contained therein.

[0034] In order to introduce the deactivation wiping kit 100 into a cleanroom, it (and its contents) must first be sterilized. In one embodiment, a portion of the deactivation wiping kit 100 is irradiated to avoid introducing contaminants into the environment. Second pouch 104 and third pouch 106 contain chemicals that can be ultimately irradiated sterilized, such as those described herein. Therefore, assembled pouches 104, 106 can undergo known final irradiation sterilization. However, first pouch 102 contains chemicals that cannot be ultimately irradiated sterilized (i.e., sodium hypochlorite). Thus, first pouch 102 is configured differently from second pouch 104 and third pouch 106 such that chemicals can be added after first pouch 102 has been sterilized.

[0035] like Figure 2 As shown, the first pouch 102 is designed with a one-way valve 208 located at its end 210, and the pouch 102 contains a wiping agent 209. Figures 3A to 3EThe valve 208, shown more fully in the diagram, allows fluid to flow through it only in one direction. Thus, the first pouch 102, containing only dried swabs, can be subjected to final irradiation sterilization together with the second pouch 104 and the third pouch 106 (each containing swabs and a corresponding chemical substance). Then, when pouches 102, 104, and 106 are transferred to the cleanroom, the first pouch 102 can be aseptically filled with a sterile hypochlorite solution via the one-way valve 208 to impregnate the dried swabs contained therein. The sterile hypochlorite solution can have any concentration suitable for determination by one of ordinary skill in the art. For example, a hypochlorite concentration of 5.25% is used. At this point, the deactivated swab kit 100 is fully ready for use in a cleanroom. The swabs intended for use in the kit can have any conventional size known in the art, exemplary being 3”×4”, 4”×6”, 9”×9”, 9”×12”, or 12”×12”.

[0036] exist Figure 4 The process for preparing the deactivation wipe kit 100 is outlined in the flowchart. Each sachet 102, 104, and 106 can be prepared sequentially or simultaneously by different technicians. Therefore, steps 400, 402, and 404 can be performed sequentially or simultaneously. As described more fully below, each step utilizes the aforementioned chemical substances and materials.

[0037] In step 400, the dried wiping material is placed into a first pouch 102 and airtightly sealed to form a first closed or sealed container or pouch. In this step, no chemicals are present in the first pouch 102. A first solution, such as a thiosulfate solution (e.g., THIO-WIPE), will be used. TM The soaked swab is placed in a second pouch 104 and airtightly sealed to form a second closed or sealed container or pouch, step 402. A second solution, such as 70% IPA (by concentration), is then used (e.g., The soaked wiping material is placed into a third pouch 106 and airtightly sealed to form a third closed or sealed container or pouch, step 404. In step 406, each of pouches 102, 104, and 106 is airtightly sealed to enclose the contents of each pouch. In one embodiment, the airtight seal is a liquid-tight and airtight seal of pouches 102, 104, and 106, such as a heat seal. Although the heat seal (step 406) is shown as a separate step, it may be part of each of the filling processes of steps 400, 402, and 404.

[0038] Assemble each of the first sealed pouch 102, the second sealed pouch 104, and the third sealed pouch 106 in preparation for irradiation sterilization, step 408. Assemble each of the first sealed pouch 102, the second sealed pouch 104, and the third sealed pouch 106 together and place them in a first container, such as a first plastic bag, and then hermetically seal the first plastic bag to form a first closed or sealed pouch shell, step 410. Optionally, the first sealed pouch shell may be placed in a second container, such as a second plastic bag, and then hermetically seal the second plastic bag to form a second closed or sealed pouch shell. In one embodiment, the first and second plastic bags are heat-sealed polyethylene bags. The second (or first) sealed pouch shell is then placed in a plastic-lined bag (e.g., a polyethylene bag) and sealed and placed in a box or other container. The liner is then closed (e.g., by knotting or by fasteners (ties)) and the box is closed to form a closed package, step 412. The container and its sealed contents are then subjected to final irradiation sterilization using known techniques and equipment, step 414, and can be transported to an irradiator for sterilization to form a sterilized sealed container. Irradiation sterilizes the container and its contents, including plastic bags, swabs, pouches, and solutions.

[0039] The irradiated box (sterilized closed container) is then transferred to a clean environment, and the sterilized closed pouch shell is removed from the plastic-lined bag. The sterilized first, second, and third sealed pouches are then removed from the innermost sealed plastic bag, step 416. At this point, the second sealed pouch 104 and the third sealed pouch 106 are ready for use. However, the first sealed pouch 102 must be filled with deactivating chemicals. In one embodiment, the first sealed pouch 102 is aseptically filled with a sterile hypochlorite solution in a clean room via a one-way valve 208, step 418. In this step, as the first pouch 102 is filled with solution, the solution is allowed to permeate the dried wipes in the pouch 102, thereby preparing hypochlorite-permeable wipes. Valve 208 may be designed to close automatically, but other suitable valve designs are available.

[0040] Once valve 208 is closed, the first sealing pouch 102 forms a first closed or sealed filler pouch, which is also ready for use. Optionally, the first sealing filler pouch 102 may be continuously hermetically sealed in a first container, and optionally then hermetically sealed in a second container, such as a plastic bag, to form a first (and second) first filler pouch shell. Once the first sealing filler pouch 102 (or the first filler pouch shell / second filler pouch shell) is ready for use, it is matched with one of an irradiated second sealing pouch 104 and one of an irradiated third sealing pouch 106 to form a deactivated wiping kit 100. Optionally, the deactivated wiping kit 100 may be continuously hermetically heat-sealed in a first container (e.g., a polyethylene bag), and optionally then hermetically heat-sealed in a second container (e.g., a polyethylene bag), such as a plastic bag. Multiple wiping kits 100 are then placed together in a carton with a plastic liner. The plastic liner may be closed (e.g., by knotting or by fasteners (ties)) and the carton is closed to form a final closed package. The box can then be shipped to the customer for use.

[0041] Alternative processes for preparing the deactivation wiping kit 100 can also be performed. The drying, wiping, and placement of the material in the first pouch 102 (step 400) can be performed before, during, or after placing the thiosulfate-impregnated wiping material into the second pouch 104 (step 402) and before, during, or after placing the IPA-impregnated wiping material into the third pouch 106 (step 404). Similarly, the placement of the thiosulfate-impregnated wiping material into the second pouch 104 (step 402) and the placement of the IPA-impregnated wiping material into the third pouch 106 (step 404) can occur in any order relative to the preparation of the other pouches, provided that all three pouches 102, 104, and 106 can be prepared prior to the heat-sealing step, if packaged together in the same box. However, the irradiated second and third pouches can be packaged together in a separate box from the first final pouch.

[0042] Furthermore, it should be understood that other suitable techniques can be used to irradiate and sterilize pouches 102, 104, and 106. For example, multiple pouches 102, 104, and / or 106 can be heat-sealed in the same or different individual first (and optionally second) plastic bags. In one embodiment, each sealed pouch 102, 104, 106 can be individually packaged in single or double bags (i.e., heat-sealed in a first plastic bag (and optionally consecutive second plastic bags) to form corresponding first and second sealed outer shells for the first, second, and third sealed pouches), then placed in a carton liner and box for sterilization. In another embodiment, multiple first sealed pouches 102 can be heat-sealed together in a first bag to form a first outer shell, multiple second sealed pouches 104 can be heat-sealed in a second bag to form a second outer shell, and multiple third sealed pouches 106 can be heat-sealed in a third bag to form a third outer shell; and the first, second, and third outer shells can be placed in a liner and box and irradiated simultaneously.

[0043] Furthermore, multiple first sealed pouches 102 can be individually packaged in single or double bags and placed in a first box; multiple second sealed pouches 104 can be individually packaged in single or double bags and placed in a second box; and multiple third pouches 106 can be individually packaged in single or double bags and placed in a third box. Alternatively, multiple first sealed pouch shells can be placed in a first box for irradiation, and multiple second and third pouch shells can be placed together in a second box for irradiation. Additionally, the first and second containers can be any suitable containers, such as pouches, and the first pouch 102, second pouch 104, and third pouch 106 can be any suitable containers.

[0044] Therefore, the end user receives a single box containing multiple kits, each kit having a sealed pouch sterilized first, second, and third time. Figure 5This document outlines the method for using the deactivation wiping kit 100. Once the kit arrives at the customer's location, the kit and its liner are opened (e.g., in a cleanroom or benchtop area). The kit 100 can then be removed from the kit for use and brought into the cleanroom. The heat-sealed bag is opened and pouches 102, 104, and 106 are removed. As described in step 500, the first pouch 102 is opened (e.g., by tearing through perforation 212) and the hypochlorite-impregnated wiping material is removed. The wiping material is then applied to the contaminated work surface to deactivate (one or more) hazardous agents, step 502. Next, the second pouch 104 is opened and the thiosulfate-impregnated wiping material is removed, step 504. The wiping material is then applied to the work surface that was just treated with the hypochlorite-impregnated wiping material, step 506, to clean the surface and remove any hypochlorite residue that may still be present on the surface. The third pouch 106 is then opened and the IPA-impregnated wiping material is removed, step 508. Finally, the wiping agent is applied to the work surface to disinfect and clean it, making it safe for use by technicians or workers, step 510. Once each wiping agent has been used consecutively on the surface, any harmful substances present are deactivated and purified, and the surface is disinfected and safe for use by technicians.

[0045] Therefore, various variations of the invention are apparent within its scope. The first, second, and third pouches may be individually packaged in single / double pouches (i.e., hermetically sealed within the first pouch and a successive second pouch). Alternatively, the second and third pouches may be packaged together in single / double pouches for irradiation and delivery to the end user; and may be packaged in a box with the double-packed first filled pouch shell, or separately from the single / double-packed first filled pouch shell. Other variations are possible within the spirit and scope of the invention. For example, the end user may receive a first box containing the first sterilized sealed pouch and a second box containing the second and third sterilized sealed pouches. Furthermore, although the invention is described as being used with three pouches, each containing a different solution, other suitable numbers of pouches and solutions, such as two, four, or more, may be provided.

[0046] For example, in Figure 6 , Figure 7 Another exemplary non-limiting example of the invention is shown below. Here, an alternative example of a first pouch 250 is shown. The pouch 250 has two polyethylene layers 270, 272, which are positioned at the edges (or as shown below). Figure 7 As shown, they are directly sealed to each other, or as... Figure 6The bag (shown with sidewalls) is heat-sealed to define an internal space 274 therebetween. The bag is substantially rectangular in shape, having two longitudinal sides and two transverse sides, the transverse sides being substantially perpendicular to the longitudinal sides. A transverse connecting assembly (e.g., a fragile seal 260) is formed in the middle to define a first compartment 252 and a second compartment 254. The first compartment 252 has a first layer 270a, a second layer 272a, and an internal space 274a therebetween, and the second compartment 254 has a first layer 270a, a second layer 272a, and an internal space 274b therebetween. The fragile seal 260 is substantially parallel to the transverse sides and extends over the entire width of the bag 250. The first compartment 252 and the second compartment 254 are completely liquid-tight, such that liquid cannot flow from the first compartment 252 to the second compartment 254, and vice versa.

[0047] During operation, through the two longitudinal sides of layers 270 and 272 (or as... Figure 7 As shown, they are directly sealed to each other, or as... Figure 6 The layers 270 and 272 (with sidewalls shown) are heat-sealed and a fragile heat seal 260 is applied to form a pouch 250. A dried wipe 256 is then placed in the interior space 274b of the second compartment 254, and the bottom lateral side is heat-sealed to completely enclose the wipe 256 within the second compartment 254. Laser notches 262 can be formed along at least a portion of the second compartment 254, extending across the entire width of the pouch 250 as shown here. Furthermore, a valve 258 is located on the top lateral side, and the entire top lateral side of both layers 270 and 272 is heat-sealed to engage the valve 258 at the top of the first compartment 252. The entire pouch 250 is then sterilized by irradiation.

[0048] Here, liquid is filled into the interior space of the first compartment 252 through valve 258. In one embodiment, the liquid is a disinfectant, such as bleach, which is filtered and aseptically filled into the first compartment 252 within the cleanroom. The pouches 250 are then packaged for delivery to the cleanroom for use, for example by consecutively double-packing them in two polyethylene bags and placing them in a plastic liner, and then placing them in a cardboard box for delivery.

[0049] The fragile seal 260 is weaker than the outer heat seal. The fragile seal 260 can be formed (e.g., by bonding at a lower heat). When the wipe 256 is ready for use, the user opens the outer packaging. The user then presses the first compartment 252 and / or the second compartment 254, which breaks the fragile seal 260. The internal spaces 274a, 274b of the first compartment 252 and the second compartment 254 are then in liquid communication with each other, thereby breaking the seal 260 and releasing liquid from the first compartment 252 to contact the wipe 256 in the second compartment. The fragile seal 260 does not weaken the outer plastic layer forming the pouch 250, so the pouch 250 is liquid-proof and no liquid leaks out of the pouch 250. Once the liquid is absorbed by the wipe 256, the user opens the second compartment 254 along the laser-etched groove 262. The user then removes the wet wipe 256 from the internal space 274 for use in a cleanroom.

[0050] In this way, the liquid does not come into contact with the wipe 256 until it is used, which can be important in cases where the liquid (e.g., bleach) might degrade the wipe 256. This extends the product's shelf life. It should also be noted that the pouch 250 can be formed in any suitable manner, although a fragile heat seal 260, notches 262, and two longitudinal seals can be formed before the wipe 256 is introduced, so that the wipe 256 is not accidentally stuck or damaged by any of these operations. However, in another embodiment, the bottom transverse side and the two longitudinal sides can be heat-sealed. The wipe 256 can then be placed inside the pouch 250, and the fragile heat seal 260 and the top transverse heat seal applied. In another embodiment of the invention, the wipe 256 can be placed between two layers 270, 272, and then all seals are formed simultaneously, including the fragile seal 260 and the heat seals along the longitudinal sides and on the top and bottom transverse sides.

[0051] Figure 6 The double compartments 252 and 254 of the small bag 250 can be used together with the second small bag 104 and the third small bag 106 for applications involving Figures 1 to 5 In systems and methods. For example, a pouch 250 containing dried wiping material 256 can be irradiated together with a second pouch 104 and a third pouch 106. However, Figure 6 The dual-compartment bag 250 also has its own independent purpose and can be used in other suitable applications without needing to be used with the second bag 104 and the third bag 106. For example, when only a single wipe is needed, bag 250 can be used alone.

[0052] It should also be noted that the present invention shows and describes a pouch 250 having two compartments 252, 254 separated by a fragile seal 260. The two compartments 252, 254 are directly connected to each other and separated by the fragile seal 260, such that when the seal 260 is opened, the compartments 252, 254 are in liquid communication with each other. It should be noted that, within the spirit and scope of the invention, the two compartments can be otherwise positioned in communication with each other without using a fragile seal, for example, by using a valve or other connecting device or assembly.

[0053] Furthermore, it should be noted that the fragile seal 260 is shown extending across the entire width of the pouch 250. Note that the fragile seal 260 does not necessarily need to extend across the entire width. For example, a portion of the seal 260 may be a fully heat-sealed seal permanently separating the first compartment 252 from the second compartment 254, and a portion of the seal 260 may be a fragile seal that can be opened to release liquid from the first compartment 252 into the second compartment 254.

[0054] In addition, such as Figure 7 As shown, the fragile seal 260 seals the first layer 270 directly onto the second layer 272 (which is flat), such that the two layers 270, 272 merge together at the seal. Therefore, the first layer 270 is directly sealed to the second layer 272 without any other material in between. In this way, the seal 260 forms a tapered region between the first compartment 252 and the second compartment 254. The seal 260 can have any suitable thickness, either small enough to form a line or pinch, or wide enough to form a flat region. In one embodiment, the seal 260 can have a thickness of approximately 0.3125 inches, the first compartment can have a length of approximately 5.3125 inches, the second compartment can have a length of approximately 6.375 inches, and the pouch can have a width of approximately 4.5 inches and a total length of approximately 12 inches. The first compartment can hold approximately 30 mL of liquid or solution, and the second compartment can hold one or more folded 12×12 woven wipes. Additionally, as shown, the seal 260 need not be linear, but may have other shapes, such as curved ones. In another embodiment of the invention, the first compartment 252 may have the same dimensions as the second compartment 254, or have different dimensions that are smaller or larger than the second compartment 254. The first and second compartments may typically be square or rectangular, or other suitable sizes and shapes.

[0055] As shown, Figure 7 This shows that the longitudinal sides of the first layer 270 and the second layer 272 are directly heat-sealed to each other. And... Figure 6The pouch 250 is shown to have sidewalls extending between the longitudinal sides of the first layer 270 and the second layer 272 of the first compartment 252 and / or the second compartment 254. The sidewalls allow the layers 270, 272 to be separated on the longitudinal sides, thus enabling them to retain more liquid, substance, or product within the compartments 252, 254. The sidewalls are heat-sealed to the first layer 270 and the second layer 272. For example, the sidewalls may be substantially rectangular and taper to a point or rectangle, with the first longitudinal side attached to the first layer 270 and the second longitudinal side attached to the second layer 272. Each longitudinal side of the pouch 250 may have one side sealed in the middle by a brittle seal 260, or there may be two longitudinal sides, one for the first compartment 252 and one for the second compartment 254. In operation, the sidewalls can be heat-sealed to layers 270, 272 in a single heat-sealing operation that applies a heat seal to each longitudinal side of the sidewall, or in two heat-sealing operations that apply a heat seal to the first longitudinal side and a heat seal to the second longitudinal side.

[0056] In another embodiment, additional lateral brittle seals may be provided to define two or more liquid-tight compartments within the bag. For example, a first compartment containing a first product (e.g., a dry wipe), a liquid, or a substance; a second compartment containing a second product, liquid, or substance; and a third compartment containing a third product, liquid, or substance. These compartments may be arranged such that they are all in communication with each other when the brittle seal is broken, or the second compartment may be located between the first and second compartments, such that the first and third compartments communicate only with the second compartment. Furthermore, the brittle seals may have different break points or be broken individually, such that, for example, the first brittle seal can be broken to release contents from the first compartment into the second compartment, and then the second brittle seal can be broken to release contents from the first and second compartments into the third compartment.

[0057] refer to Figures 8 to 9 An embodiment of the invention is illustrated. A pouch 300 has a pouch body 310 formed by a first layer 301 and a second layer 303. The pouch 300 has an outer peripheral seal and an inner seal. The outer peripheral seal is located on the longitudinal and transverse sides and forms a first longitudinal side or sidewall 305, a second longitudinal side or sidewall 307, a top portion or top wall 309, and a bottom portion or bottom wall 311, defining the outer periphery of the pouch 300. The pouch is substantially rectangular in shape, whereby the top portion 309 and the bottom portion 311 are transverse and orthogonal to the first longitudinal side 305 and the second longitudinal side 307.

[0058] The internal seal is a connecting assembly comprising an internal transverse seal 313 and an internal compartment seal 315. The internal transverse seal 313 extends transversely across the entire width of the pouch 300 from the first longitudinal side 305 to the second longitudinal side 313. The internal transverse seal 313 is closer to the top end 309 of the pouch than to the bottom end 311. The internal transverse seal 313 is substantially parallel to the top end 309 and bottom end 311 of the pouch. The internal compartment seal 315 extends from approximately the middle of the internal transverse seal 313 to the top end 309 of the pouch, substantially parallel to the longitudinal sides 305 and 307, thereby making the third compartment 340 longer than the first compartment 320 and the second compartment 330.

[0059] The inner seal and the outer seal together form various internal compartments of the pouch 300. In the illustrated embodiment, the inner seal forms a first compartment 320 having a first internal space, a second compartment 330 having a second internal space, and a third compartment 340 having a third internal space. The first compartment 320 retains a first chemical substance (such as bleach) within its first internal space and is defined by a first longitudinal seal, a top seal, an inner transverse seal 313, and an inner compartment seal 315. The second compartment 330 retains a second chemical substance (such as WFI) within its second internal space. Thus, the first and second chemical substances remain separate from each other during manufacturing, transportation, and storage, and can be combined just before use to prevent degradation of the chemicals before use and extend shelf life.

[0060] In the illustrated embodiment, the internal compartment seal 315 is located at the center of the internal transverse seal 313 and the top portion 309, so that the first compartment 320 and the second compartment 330 are of equal size. However, the internal compartment seal 315 may be formed closer to one of the longitudinal sides 305, 307, so that the first compartment 320 and the second compartment 330 have different sizes. Furthermore, other internal seals defining additional compartments may be provided. And, although compartments 320, 330, and 340 are shown arranged side-by-side, the compartments may be formed entirely within the other compartments. Although the internal seals 313 and 315 are shown in contact with each other, the seals may be formed in any suitable location and do not need to be in contact with each other. Therefore, the compartments have various configurations.

[0061] As further shown, a first port or valve 312 is provided in the first compartment 320, and a second port or valve 314 is provided in the second compartment 330. Valves 312 and 314 are unidirectional and allow liquid to be filled into the first internal space of the first compartment 320 and the second internal space of the second compartment 330. Although valves 312 and 314 are shown at the top 309 of the pouch, valves may be provided elsewhere, such as on the front (i.e., formed in the first layer 301) and / or the back (i.e., formed in the second layer 303) of the pouch.

[0062] The first seal 315 and the second seal 313 can be configured such that they can be broken individually; for example, the first seal 315 can be broken without breaking the second seal 313. For instance, the first seal 315 can be weaker than the second seal 313. Alternatively, the first seal 315 can be positioned sufficiently separate from and / or at an angle to the second seal 313. Thus, a user can engage the pouch body 310 near the respective seals 315, 313 to selectively break the first seal 315 without breaking the second seal 313, to combine the bleach contained in the first compartment 320 with the WFI contained in the second compartment 330, and to allow the bleach and WFI to mix together. The user can then subsequently break the second seal 313 to release the combined bleach and WFI formulation onto the dry wipe 302.

[0063] The third compartment 340 holds the product (such as wiping material 302) in a third internal space. Compartments 320, 330, and 340 are liquid-tight and separated from each other. In this way, the third compartment 340 remains separate from the liquids in the first and second compartments 320 and 330, ensuring the wiping material remains dry during manufacturing, transportation, and storage. Liquids can be mixed and introduced into the dry wiping material 302 just before use to prevent degradation and extend shelf life. When the pouch 310 is ready for use, the internal seals 313 and 315 can be opened to saturate the wiping material 302 with the liquid contained in the first and second compartments 320 and 330 to deactivate and / or purify hazardous drugs and disinfect work surfaces in a cleanroom environment. It should be noted that the pouch and compartments include walls on their respective sides or ends.

[0064] An entrance or cover 304 is provided in the third compartment 340, which allows the wipe 302 to be removed when ready for use. Figure 8 , Figure 9In the illustrated embodiment, the cap 304 is a press-fit and sealant cap. An opening 308 is formed in the top layer 301 of the third compartment 340. The cap 304 is larger than the opening 308 and is applied above and around the opening 308. The cap 304 has an access pull tab 306, which can be opened and then closed and resealed by the user. Thus, when the user is ready to remove the wipes, the user opens the third compartment 340 by peeling back the access pull tab 306, exposing the soaked wipes 302. The user then removes the desired number of wipes 302 by pulling them through the opening 308 and the access pull tab opening, and presses the access pull tab 306 back into position to seal and close the third compartment 340.

[0065] In an alternative embodiment, a peel and seal cap 304 is not required. Instead, the user can access the wipe 302 through a notch or perforation in the side 342 of the third compartment 340. The notch may be formed in the side 342 of the third compartment 340, allowing the user to tear open the third compartment 340 by pulling on the side of the pouch at the notch. Thus, in use, a technician pulls along the perforation to tear open the two layers of the pouch to access the soaked wipe contained therein.

[0066] Therefore, the first compartment 320 has a bottom side or bottom end portion 321 formed by the inner transverse seal 313, a first longitudinal side 322 formed by a portion of the first longitudinal side 305 of the pouch, a top side or top portion 323 formed by a portion of the top portion 309 of the pouch, and a second longitudinal side 324 formed by the inner compartment seal 315. As further shown, the inner compartment seal 315 may be formed as a burst or shatterproof seal, configured to open when a user applies a certain amount of pressure to the seal 315. The shatterproof seal may include the entire inner compartment seal 315, or, as shown, only a portion of the inner compartment seal 315. The inner compartment seal 315 may form the entire second longitudinal sidewall 324, or, as shown, only a portion of the second longitudinal sidewall 324.

[0067] The second compartment 330 has a bottom side or bottom end portion 331 formed by the inner compartment seal 315, a first longitudinal side 332 formed by the inner compartment seal 315, a top side or top end portion 333 formed by a portion of the top end portion 309, and a second longitudinal side 334 formed by a portion of the second longitudinal side 307 of the pouch. The third compartment 340 has a bottom side or bottom end portion 341 as the bottom pouch end portion 311, a first longitudinal side 342 formed by a portion of the first longitudinal side 305 of the pouch, a top end portion or top side 343 formed by the inner transverse seal 313, and a second longitudinal side 344 formed by a portion of the second longitudinal side 307 of the pouch. Therefore, the first side 305 of the pouch forms the first longitudinal side 322 of the first compartment 320 and the first longitudinal side 342 of the third compartment 340, and the second longitudinal side 307 of the pouch forms the first longitudinal side 334 of the second compartment 330 and the first longitudinal side 344 of the third compartment 340. Furthermore, the top portion 309 of the pouch forms the top portion 323 of the first compartment 320 and the top portion 333 of the second compartment 330. The internal transverse seal 313 may form the entire bottom 331, or, as shown, only a portion of the bottom 331.

[0068] In order to introduce pouch 300 into the cleanroom, it (and its contents) must first be sterilized. In one embodiment, a portion of pouch 300 is irradiated to prevent the introduction of contaminants into the environment. The swabs 302 and WFI in the second compartment 330 can be subjected to final irradiation sterilization, such as by the methods described herein. Thus, pouch 310 can undergo known final irradiation sterilization. However, the first compartment 320 contains chemicals that cannot be subjected to final irradiation sterilization (i.e., bleach). Therefore, pouch 310 is configured such that after the swabs 302 in the third compartment 340 have been sterilized, the chemicals can be added to the first compartment 320 (and optionally the WFI in the second compartment 330).

[0069] The pouch 300 is designed with a first one-way valve 312 and a second one-way valve 314 located at the top portions 323 and 333 of each of the first compartment 320 and the second compartment 330, respectively. These valves 312 and 314 allow fluid to flow through them in only one direction. Therefore, the pouch 300, which contains only dried wipes 302 in the third compartment 340 and optionally WFI in the second compartment 330, can be subjected to final irradiation sterilization. Then, when the pouch 300 is transferred to the cleanroom, the first compartment 320 can be aseptically filled with sterile bleach via the first one-way valve 208 to impregnate the dried wipes contained therein. The sterile bleach solution can have any concentration suitable for determination by a person skilled in the art. At this point, the pouch 300 is fully ready for use in the cleanroom. The wipes intended for assembly may have any conventional size known in the art, exemplarily 3”×4”, 4”×6”, 9”×9”, 9”×12”, or 12”×12”.

[0070] The process for preparing the pouch 300 is outlined here. These steps may be performed sequentially or simultaneously. As described more fully below, each step utilizes the aforementioned chemicals and materials. Layers 301 and 303 of the pouch body 310 are hermetically and heat-sealed along left side 322, left side 342, right side 334, right side 344, top 323, top 333, and bottom 341, as well as inner walls 321, inner walls 324, and inner walls 331, to form the corresponding sides of the pouch and compartments. First port 312 and second port 314 are integrally sealed to the top end 323 of the first compartment 320 and the top end 333 of the second compartment 330, respectively. Then, a first burst seal 315 and a second burst seal 313 are formed in the pouch body 310.

[0071] At this stage, the right side 344 of the third compartment 340 has an opening 345 therein, allowing the dried swab 302 to be placed in the third compartment 340. The right side of the third compartment 340 is then hermetically sealed to form a closed or sealed third compartment. At this point, there are no chemicals in the pouch 300. Optionally, at this point, WFI can be filled into the second compartment through the second port 314. The sealed pouch 310 is then assembled in preparation for irradiation sterilization. For example, the pouch 300 can be placed in a first plastic bag, which is then hermetically sealed to form a first closed or sealed pouch shell. Optionally, the first sealed pouch shell can be placed in a second container, such as a second plastic bag, which is then hermetically sealed to form a second closed or sealed pouch shell. In one embodiment, the first and second plastic bags are heat-sealed polyethylene bags. The second (or first) sealed pouch shell is then placed in a plastic-lined bag (e.g., a polyethylene bag), sealed, and placed in a box or other container. The liner is then sealed (e.g., by knotting or fastening (ties)) and the box is closed to form a sealed package. The box and sealed contents are then subjected to final irradiation sterilization using known techniques and equipment, and can be transported to an irradiator for sterilization to form a sterilized sealed container. Irradiation sterilizes containers and their contents, including plastic bags, swabs, pouches, and solutions.

[0072] The irradiated box (sterilized closed container) is then transferred to the clean environment, and the sterilized closed pouch shell is removed from the plastic-lined bag. The sterilized pouch 300 is then removed from the innermost sealed plastic bag. At this point, bleach is aseptically filled into the first compartment 320 within the cleanroom via one-way valve 312. Furthermore, if WFI was not previously filled into the second compartment 330, it can be filled at this time via the second port 314. Valves 312 and 314 are designed to close automatically, but other suitable valve designs are available.

[0073] Once valves 312 and 314 are closed, pouch 300 forms a closed or sealed filler pouch, ready for use. Optionally, pouch 300 may be continuously and hermetically sealed in a first container, and optionally then hermetically sealed in a second container, such as a plastic bag or polyethylene bag, to form a first (and second) first filler pouch shell. Multiple wipe pouches 300 are then placed together into a carton with a plastic liner. The plastic liner may be closed (e.g., by knotting or by fasteners (ties)) and the carton is closed to form a final sealed package. The carton can then be shipped to the customer for use.

[0074] Alternative processes for preparing the pouch 300 can also be performed. For example, heat sealing and burst sealing can be performed in any order. Furthermore, it should be understood that other suitable techniques can be used to irradiate and sterilize the pouch 300. For example, multiple pouches 300 can be heat-sealed in the same or different individual first (and optionally second) plastic bags. In one embodiment, each pouch 300 can be individually single-bag / double-bag packed (i.e., heat-sealed in a first plastic bag (and optionally consecutive second plastic bags) to form corresponding first and second sealing shells for the first, second, and third closed pouches), then placed in a carton liner and box and sterilized.

[0075] This outlines the method of using the pouch 300. Once the box arrives at the customer's location, the box and its liner are opened (e.g., in a cleanroom or benchtop area). The pouch 300 can then be removed from the box for use and brought into the cleanroom. The heat-sealed pouch is opened and the pouch 300 is removed. The user then breaks the first burst seal 315 between the first compartment 320 and the second compartment 330 to introduce bleach into the WFI. Once the bleach and WFI are mixed, the user breaks the second burst seal 313 between the second compartment 330 and the third compartment 340 to introduce the bleach / WFI mixture onto the wipe 302. Once the wipe 302 is saturated with the mixed bleach and WFI, the user opens the third compartment 340 (e.g., by opening the access pull tab 306 or tearing a perforation) and removes the wipe saturated with diluted bleach. The wipe is then applied to the contaminated work surface to clean the hazardous substance.

[0076] The first compartment 320, the second compartment 330, and the third compartment 340 are completely liquid-tight, including all peripheral and internal seals, preventing liquid from flowing from the first compartment 320 to the second compartment 330, or vice versa, or otherwise escaping from the pouch 300. Furthermore, liquid cannot flow from either the first compartment 320 or the second compartment 330 to the third compartment 340.

[0077] Bursting seals 315 and 313 are fragile and weaker than the peripheral heat seals used for the longitudinal sides 305 and 307, and the top 309 and bottom 311. The fragile seals 315 and 313 can be formed (e.g., by bonding at a lower temperature), and the first bursting seal 315 can be subjected to a lower temperature than the second bursting seal 313, making the first bursting seal weaker than the second bursting seal. When the wipe 302 is ready for use, the user opens the outer packaging. The user then presses the first compartment 320 and / or the second compartment 330, which breaks the first fragile seal 315. The internal spaces of the first compartment 320 and the second compartment 330 are then in liquid communication with each other, thereby breaking the seal 315 and releasing liquid from the first compartment 320 to contact the liquid in the second compartment 330.

[0078] The user then presses the second compartment 330 or the third compartment 340, which breaks the second fragile seal 313. The internal spaces of the second compartment 330 and the third compartment 340 are then in liquid communication with each other, thereby breaking the seal 313 and releasing liquid from the first compartment 320 and the second compartment 330 to contact the wiping material in the third compartment 340. The fragile seals 315 and 313 do not weaken the outer plastic layer forming the pouch 310, thus the pouch 310 is liquid-proof and no liquid leaks out of the pouch 310. Once the liquid is absorbed by the wiping material 302, the user opens the third compartment 340 at the press and seal cap 304. The user then removes the wet wiping material 302 from its internal space for use in the cleanroom.

[0079] In this way, the liquid does not come into contact with the wipe 302 until it is used, which can be important in cases where liquids (such as bleach) might degrade the wipe 302. This extends the product's shelf life. It should also be noted that the pouch 300 can be formed in any suitable manner, although fragile heat seals 315, 313, and peripheral seals can be formed before the wipe 302 is introduced, so that the wipe 302 is not accidentally jammed or damaged by any of these operations. However, in another embodiment, the bottom lateral side and both longitudinal sides can be heat-sealed. The wipe 302 can then be placed in the third compartment 340, and the fragile heat seals 315, 313, and top lateral heat seals applied. In another embodiment of the invention, the wipe 302 can be placed between two plastic layers, and all seals are then formed simultaneously, including the fragile seals and heat seals along the longitudinal sides and on the top and bottom lateral sides.

[0080] It should also be noted that the present invention shows and describes a pouch 300 having compartments 320, 330, and 340 separated by fragile seals 315 and 313. Compartments 320, 330, and 340 are directly connected to each other and separated by fragile seals 315 and 313, such that when seals 315 and 313 are opened, compartments 320, 330, and 340 are in liquid communication with each other. It should be noted that, within the spirit and scope of the invention, the compartments can be otherwise arranged in communication with each other without the use of fragile seals, for example, by using valves or other connecting devices or assemblies.

[0081] Furthermore, although both the first compartment 320 and the second compartment 330 are shown to have ports 312 and 314, only one of those compartments may have a port. For example, the second compartment 330 contains a WFI that can be irradiated and sterilized. In one embodiment, when the compartment is formed so that no port is required, the WFI can be filled into the second compartment 330, and the WFI can be irradiated and sterilized simultaneously with the dried wipe 302. The first port 312 can then be used to aseptically fill the first compartment 320 with a bleach that cannot be irradiated and sterilized.

[0082] It should also be noted that the fragile seal 315 is placed between the first and second compartments, and there is no fragile seal between the first and third compartments. Instead, the seal 313 between the first and second compartments will not break during use and remains intact during use. In this way, the chemicals in the first and second compartments can mix together before they are introduced into the wipe 302 in the third compartment. Furthermore, there is no direct liquid flow communication between the first compartment 320 and the third compartment 340. Instead, liquid in the first compartment 320 cannot reach the third compartment 340 without first flowing through the second compartment 330. The first compartment 320 contains the most degradable chemical, bleach, so that it will not degrade the wipe 302 if the second fragile seal 313 is broken simultaneously with or before the first fragile seal 315.

[0083] Furthermore, the first layer 301 is directly sealed to the second layer 303 without any other material in between. In this way, fragile seals 315 and 313 form a conical region between compartments 320, 330, and 340. Seals 315 and 313 can have any suitable thickness, either small enough to form a line or pinch, or wide enough to form a flat area. In one embodiment, the pouch 300 can have a length of 13.5 inches and a width of 11.81 inches, and the first compartment can have a length of approximately 5 inches, and the third compartment can have a length of approximately 8.5 inches. The first and second compartments can each contain approximately 170 mL of liquid or solution, and the third compartment can contain one or more folded 12×12 woven wipes. Additionally, as shown, the seals do not have to be linear, but can have other shapes, such as curved ones. In another embodiment of the invention, the first compartment can have the same dimensions as the second compartment, or have different dimensions that are smaller or larger than the second compartment. The first, second, and third compartments can typically be square or rectangular, or other suitable sizes and shapes.

[0084] Figures 10 to 14 Another exemplary embodiment of the invention is shown. Here, the two top compartments are shown to have different dimensions. The top left compartment is larger than the top right compartment but smaller than the bottom compartment. The top left and top right compartments have the same height, but the left compartment is wider than the right compartment. This can be done, for example, in a case where the left compartment contains a diluent such as water for injection (WFI), while the right compartment contains a concentrate such as bleach. In one embodiment, dimensions and sizes are shown... Figure 14 In operation, the user rolls up the pouch from the top left corner. This forces the liquid in the top left compartment to move to the right, which also increases the pressure in the top left compartment. This pressure continues to increase until it eventually breaks the fragile or burst seal between the two top compartments, thus releasing the WFI into the concentrate.

[0085] Therefore, these liquids are mixed together by pressing the pouch. When they are fully mixed, the user can roll up the pouch from the top left corner or from the top until the burst seal between the top right compartment and the lower compartment breaks, releasing the mixed composition into the lower compartment. The mixed composition then comes into contact with and saturates the wipe. The wipe can then be removed by opening the top to access the pull tab 306. Figures 10 to 14 This is one example embodiment, and other relative dimensions, shapes, and sizes can be provided between the compartments, and any number of compartments can be provided.

[0086] Figure 15 Another embodiment of the pouch is shown. Here, the pouch is... Figure 6 , Figure 7The embodiments are similar. Pull tabs 382 and 384 extend inwardly from each of the two longitudinal sides 307. An internal burst seal extends laterally between the two pull tabs 382 and 384 and connects to the inwardly distal ends of the two pull tabs 382 and 384. Pull tabs 382 and 384 may be relatively short and much shorter than burst seal 380, such that burst seal 380 extends almost the entire width of the pouch, so that once the seal bursts, pull tabs 382 and 384 do not impede the movement of liquid from the top compartment to the bottom compartment. However, in other embodiments, pull tabs 382 and 384 may be longer, such that pull tabs 382 and 384 are burst seal 380.

[0087] Figure 15 Small bags do not include, for example Figure 6 , Figure 7 The tear line or notch 262 shown is for removing the wipe. Instead, a peel-off and sealing cap 304 (similar to...) is provided. Figure 8 (Cover 304). Furthermore, no [item] was provided. Figure 8 The opening 345. Conversely, the right longitudinal side 307 is continuous and heat-sealed, and the bottom end 311 opens and heat-seales between layers 301 and 303 once the wiping material is placed in the bottom compartment.

[0088] Finally, it should be noted that the specification and claims use several geometric or relational terms, such as parallel, linear, curved, rectangular, perpendicular, and flat. Furthermore, the specification and claims use several directional or positioning terms, such as top, bottom, side, longitudinal, transverse, and interior. These terms are merely for the convenience of describing the embodiments shown in the accompanying drawings. These terms do not limit the invention. Therefore, it should be understood that the invention can be described in other ways without those geometric, relational, directional, or positioning terms. Moreover, the geometric or relational terms may not be precise. For example, due to factors such as surface roughness, manufacturing tolerances, etc., walls may not be precisely perpendicular or parallel to each other, but are still considered substantially perpendicular or parallel. And, other suitable geometries and relationships may be provided without departing from the spirit and scope of the invention.

[0089] Although the invention has been described in conjunction with specific forms and embodiments, it should be understood that various modifications beyond those discussed above may be made without departing from the spirit or scope of the invention. For example, equivalent elements may replace those specifically shown and described, certain features may be used independently of other features, and in some cases, the specific positions of elements may be reversed or inserted, all without departing from the spirit or scope of the invention as defined in the appended claims.

Claims

1. A method for manufacturing a wipe pouch, comprising: A first compartment is formed in the wiping pouch, the first compartment having a one-way filling valve; A second compartment is formed within the wiping pouch; The second compartment is filled with a second liquid chemical substance; A third compartment is formed within the wiping pouch; Place the dried wiping material in the third compartment; A first connecting assembly is formed to connect the first compartment to the second compartment, having a closed structure and an open structure, wherein in the closed structure the first compartment is not in communication with the second compartment, and in the open structure the first compartment is in communication with the second compartment; A second connecting assembly is formed to connect the second compartment to the third compartment, having a closed structure and an open structure, wherein in the closed structure the second compartment is not in communication with the third compartment, and in the open structure the second compartment is in communication with the third compartment; The wiping bags containing the second liquid chemical substance in the second compartment and the dried wiping material in the third compartment are subjected to irradiation sterilization. as well as The first compartment of the irradiated sterilized swab bag is filled with a first liquid chemical substance via the one-way filling valve.

2. The method of claim 1, wherein the one-way filling valve is configured to allow liquid to be filled into the first compartment while preventing the liquid from escaping from the first compartment.

3. The method of claim 1, wherein the one-way filling valve is a first one-way filling valve, and the second compartment includes a second one-way filling valve.

4. The method of claim 3, wherein the first one-way filling valve is configured to allow liquid to be filled into the first compartment while preventing the liquid from escaping from the first compartment, and the second one-way filling valve is configured to allow liquid to be filled into the second compartment while preventing the liquid from escaping from the second compartment.

5. The method of claim 1, wherein each of the first and second coupling components includes a fragile seal.

6. The method of any one of claims 1 to 5, wherein the first connecting component is weaker than the second connecting component, such that the first connecting component is configured to open without opening the second connecting component.

7. A method of using a swab pouch, the swab pouch having a first compartment formed in the swab pouch and containing a first chemical substance, a second compartment formed in the swab pouch and containing a second chemical substance present during irradiation sterilization of the swab pouch, a third compartment formed in the swab pouch and containing dried swab material present during irradiation sterilization of the swab pouch, a first connecting assembly for selectively connecting the first compartment to the second compartment, and a second connecting assembly for selectively connecting the second compartment to the third compartment, the first compartment having a one-way filling valve, whereby, after irradiation sterilization of the swab pouch, the first chemical substance is filled into the first compartment, the method comprising: The first connecting assembly is maintained in a closed configuration, in which the first compartment is not in communication with the second compartment. The second connecting assembly is maintained in a closed configuration, in which the second compartment is not in communication with the third compartment. Disrupt the first connecting assembly to place the first connecting assembly into an open configuration, in which the first compartment communicates with the second compartment to mix the first and second chemical substances; and The second connecting assembly is disrupted to place it into an open configuration in which the second compartment communicates with the third compartment to impregnate the dried wipe with a mixture of the first and second chemicals.

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