Pouch with a breakable seal

The wipe pouch with frangible seals enables efficient sterilization and use of non-irradiatable chemicals in cleanrooms, ensuring effective deactivation and disinfection while maintaining chemical integrity and safety.

JP7751886B2Active Publication Date: 2025-10-09VELTEK ASSOCIATES INC
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Patent Information

Application Number
JP2022555618
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-09-11
Filing Date
2021-03-16
Publication Date
2025-10-09
Estimated Expiration
2041-03-16

AI Technical Summary

Technical Problem

Existing cleanroom sterilization methods are inadequate for chemicals that cannot be irradiated, complicating the introduction of deactivating and disinfecting compositions into controlled environments, and conventional methods spread hazardous agents rather than inactivating them.

Method used

A wipe pouch with multiple compartments separated by frangible seals, allowing for pre-irradiation sterilization of certain compartments and aseptic filling of others, ensuring efficient transport and use in cleanrooms.

Benefits of technology

The solution effectively inactivates, decontaminates, and disinfects cleanroom surfaces while maintaining chemical stability and safety, adhering to USP and ISO standards, and extending shelf life by preventing premature chemical interaction.

✦ Generated by Eureka AI based on patent content.

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Abstract

The wipe pouch has a first compartment containing a first chemical, a second compartment containing a second chemical, and a third compartment containing dry wipes. A first coupling assembly (first breakable seal) connects the first and second compartments 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 (second breakable seal) connects the second and third compartments 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. To use, the first breakable seal is broken, mixing the bleach in the first compartment with the WFI in the second compartment. The user then breaks the second breakable seal and wets the wipes in the third compartment with the bleach / WFI mixture from the first and second compartments.
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Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit 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 by reference in their entireties into this disclosure.

[0002] FIELD OF THE INVENTION The present invention relates to wipe kits (wipe kits, wipe kits) used for deactivation, decontamination, and disinfection or cleaning in cleanroom environments, and methods for their preparation and use. [Background technology]

[0003] A clean or controlled environment is a space that is designed, maintained, and controlled to prevent particulate and microbial contamination of products. Clean environments include cleanrooms and clean work spaces (such as hooded workspaces), collectively referred to below as cleanrooms. Cleanrooms are most commonly designed for use in manufacturing facilities and medical research and processing facilities, such as in the pharmaceutical, biotechnology, and healthcare industries, to name a few. Sterile cleanroom environments can be classified according to various classification schemes, including the International Organization for Standardization (ISO) cleanroom standard, with the highest level of sterilization being an ISO 1 cleanroom and a normal atmospheric environment (non-sterile) being classified as ISO 9.

[0004] Specific chemical compositions used within cleanrooms include, for example, germicidal disinfectants such as phenols, cleaners, quaternary ammonium, and peracetic acid, as well as various sporicides such as peracetic acid, bleach, and hydrogen peroxide. Bactericides and sporicides are used within cleanrooms to disinfect (sterilize) cleanroom surfaces. In certain cleanroom environments, such as the healthcare industry, surfaces may be exposed to certain harmful agents. In these situations, chemicals capable of inactivating and decontaminating work surfaces from harmful agents are needed to reduce occupational exposure risks to technicians and other workers within the cleanroom, as well as to products and chemicals being created within the cleanroom. Methods for inactivating, decontaminating, and disinfecting / cleaning surfaces exposed to harmful agents are outlined in the United States Pharmacopeial Convention (USP). <800> and U.S.P. <797> 1. Conventional methods of cleanroom sterilization are unsuitable for this purpose because they do not fully inactivate (deactivate) hazardous agents but instead simply spread them around the affected surfaces. On the other hand, products that may inactivate hazardous substances are not suitable for use in cleanrooms classified as ISO 5.

[0005] Additionally, chemical compositions that are not normally sterile must be sterilized before entering the cleanroom to avoid the risk of contamination. Such compositions may be sterilized by filtration within the cleanroom, or may be sterilized before entering the cleanroom.

[0006] To sterilize compositions outside of a cleanroom, the collected compositions may be terminally sterilized by irradiation or aseptically processed. To terminally sterilize a composition by irradiation, the composition is placed in a container, double-bagged, and then placed in a carton with a liner. The entire carton is then terminally sterilized by radiation. Procedures for terminally sterilizing compositions by irradiation are 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 makeup and structure. For example, certain chemicals used in cleanrooms to inactivate and decontaminate hazardous agents cannot be irradiated. This creates challenges for introducing such chemicals into the cleanroom environment and complicates the sterilization process.

[0007] The present invention relates to a deactivating wipe kit that improves the deactivation, decontamination, and disinfection / cleaning of hazardous agents from sterile surfaces in cleanrooms. The deactivating wipe kit of the present invention can be irradiated outside of the cleanroom environment, allowing for more efficient transport and installation into the cleanroom. Summary of the Invention

[0008] One aspect of the present invention is the use of a wipe pouch with multiple compartments separated by one or more frangible seals. The wipe pouch may have a first compartment containing dry wipes, a second compartment connected to a one-way fill valve, and a coupling assembly (e.g., a frangible frangible seal) connecting the first and second compartments. In a closed configuration, the first compartment is not in communication (e.g., air or liquid) with the second compartment. In an open configuration, the first compartment is in communication with the second compartment. [Brief explanation of the drawings]

[0009] The present invention and many of the attendant advantages thereof will become more readily apparent as the same becomes better understood by reference to the following detailed description, when considered in conjunction with the accompanying drawings, in which:

[0010] [Figure 1] FIG. 1 is a front perspective view of a deactivating wipe kit according to one embodiment of the present invention.

[0011] [Figure 2] FIG. 2 is a front plan view of a first pouch of a deactivated wipes kit having a one-way valve, according to one embodiment of the present invention.

[0012] [Figure 3] 3A to 3E are perspective views of the one-way valve shown in FIG.

[0013] [Figure 4] 1 is a flowchart outlining steps in a method for preparing (making) a deactivating wipes kit according to one embodiment of the present invention.

[0014] [Figure 5] 1 is a flowchart outlining the steps of a method of using a deactivating wipe kit according to one embodiment of the present invention.

[0015] [Figure 6] 1 is a perspective view of a pouch according to another embodiment of the present invention having a side wall extending longitudinally between first and second bag layers.

[0016] [Figure 7] FIG. 1 is a perspective view of a pouch in which the first and second bag layers are heat-sealed directly to one another in the longitudinal and transverse directions, without side walls.

[0017] [Figure 8] FIG. 1 is a front view of a pouch according to one embodiment of the present invention having three compartments.

[0018] [Figure 9] FIG. 9 is a front view of the pouch of FIG. 8.

[0019] [Figure 10] This pouch has three compartments of different sizes.

[0020] [Figure 11] FIG. 11 is a front cutaway view of FIG. 10.

[0021] [Figure 12] FIG. 11 is a side view of FIG.

[0022] [Figure 13] FIG. 11 is a top view of FIG.

[0023] [Figure 14] FIG. 11 is a diagram showing an example of dimensions for FIG. 10.

[0024] [Figure 15] FIG. 10 shows another embodiment of the invention having two compartments. Detailed Description

[0025] Referring to FIG. 1, a deactivation wipe kit 100 is shown. As often used herein, the term "wipe kit" is used to refer to the deactivation wipe kit 100. In one embodiment, the wipe kit 100 includes three pouches 102, 104, and 106. Each of these pouches contains a wipe saturated with a different chemical used to deactivate and decontaminate hazardous drugs and disinfect work surfaces in a cleanroom environment. In use, a technician removes each wipe from each of the pouches 102, 104, 106 and applies them to the contaminated work surface in order, i.e., the wipe in the first pouch 102 is used first, the wipe in the second pouch 104 is used second, and the wipe in the third pouch 106 is used last. When used in this manner, the deactivated wipe kit 100 complies with the USP 2000 25 ... <800> and U.S.P. <797> As specified by the ISO 5001:2001 standard, most harmful drugs are inactivated, decontaminated, and sterilized / cleaned from the working environment for compounding sterile preparations (sterile formulations), such as an ISO 5 clean room.

[0026] In one embodiment, the first pouch 102 contains wipes saturated with a 5.25% hypochlorite solution, e.g., sodium hypochlorite (e.g., HYPO-CHLOR®, available from Beltec Associates, Inc., Malvern, PA). This composition is the primary (first) agent that inactivates one or more hazardous drugs. It inactivates any potentially active drugs that may be present on the preparation (work) surface, leaving the surface safe and decontaminated for subsequent handling, and meets USP guidelines for hazardous drugs (handling in healthcare facilities). <800> along with the USP Patient Protection Protocol for Compounding Sterile Preparations <797> While the use of sodium hypochlorite is preferred, any chemical known to inactivate harmful drugs may be used to infiltrate the wipes in the first pouch 102, including, but not limited to, potassium permanganate and alkaline potassium permanganate.

[0027] The second pouch 104 contains wipes saturated with a 2% thiosulfate solution, such as sodium thiosulfate (e.g., THIO-WIPE™, available from Beltec Associates, Inc.). In a preferred embodiment, the sodium thiosulfate is USP grade. This composition is used to remove hypochlorite solution residue from treated work surfaces. Thiosulfate neutralizes the corrosive hypochlorite remaining on the surface, preserving the surface's structure and preventing damage. It also functions to decontaminate the surface. While sodium thiosulfate is preferred, any chemical known to be capable of decontaminating and neutralizing hypochlorite-treated work surfaces can be used. In this way, the sodium thiosulfate solution cleans, decontaminates, and neutralizes the sodium hypochlorite solution and any harmful chemicals it previously inactivated. This improves the overall life of the sterile compounding equipment and reduces the risk of USP <797> and U.S.P. <800> can continue to comply with the

[0028] The third pouch 106 contains wipes saturated with 70% isopropyl alcohol (IPA) (e.g., ALCOH-WIPE®, available from Beltec Associates, Inc.) that function as a disinfectant (germicide). In a preferred embodiment, the IPA is USP grade. The wipes further clean and disinfect the treated surface, restoring it to its original condition for worker safety. While IPA is preferred, any chemical known to clean and disinfect work surfaces can be used, including, but not limited to, sterile water or known germicides such as phenol, quats, peroxyacetic acid (POAA), and H2O2. Thus, IPA further protects the compounding or preparation surface by providing an additional measure against contaminants present on the surface. After the work surface is inactivated, additional disinfection is necessary to maintain a controlled work environment, which is critical for preparing sterile products.

[0029] All three chemicals used in each of the pouches 102, 104, 106 may be formulated with water for injection (WFI) and may be 0.2 micron filtered. Once a surface has been thoroughly treated with all three wipes, the surface can be returned to its original composition.

[0030] Each of the wipes contained in pouches 102, 104, and 106 is preferably made of a nonwoven, non-shedding material designed to be clean, have good absorbency, and provide good surface coverage. The wipes should have good low-shedding properties, so that fibers do not easily shed from the wipe to prevent contamination of cleanroom work surfaces. In one embodiment, the wipes in first pouch 102 are made of 100% polypropylene, while the wipes in second pouch 104 and third pouch 106 are made of 100% polyester. In this embodiment, the material of each wipe is selected to be compatible with the specific chemicals contained in each of pouches 102, 104, and 106. Each of these materials is a woven wipe that is strong, has good low-shedding properties, can be used in controlled environments, and is compatible with the chemicals in which it is immersed. In one embodiment, the wipes are approximately 9 inches by 12 inches in size and are capable of treating a surface area of ​​approximately 6 square feet.

[0031] In one embodiment, the wipe for the first pouch 102 is 162XL-4019, a 48-gauge polyester with an ALOX coating bonded to 150 (6 mil) white polyethylene. This particular substrate is capable of retaining active hypochlorite, although other suitable wipes may be used. Additionally, this wipe material minimizes the degradation and instability associated with hypochlorite due to exposure to organic materials. In one embodiment, one wipe is provided for each pouch 102, 104, and 106, although one or more wipes may be provided for any or all of the pouches 102, 104, and 106.

[0032] The pouches 102, 104, and 106 themselves are designed to provide a flexible packaging structure for these wipes. The pouches 102, 104, and 106 are preferably constructed from materials that provide a barrier to moisture, air, and light, are chemically resistant, and maintain their structural integrity during exposure to radiation, clean rooms, and final shelf storage. In one embodiment, each pouch 102, 104, and 106 is constructed from a multi-layer structure made of multiple layers of coated polyester, low-density polyethylene, aluminum foil, hydroxypropyl cellulose, and / or linear low-density polyethylene. For example, the pouches 102, 104, and 106 may be ExpressWeb EFS174 from Glenroy Inc., attached hereto and incorporated by reference. When used in a multi-layer structure, these materials are airtight and liquid-tight and chemically resistant (since the stability of the final product may be affected by light, oxygen, and organic matter). They also help to maintain the active agents in each chemical and extend shelf life. Each of the pouches 102, 104, 106 preferably includes a notch or tear line (perforation) 212, as shown in the first pouch 102 in FIG. 2. The notch 212 can be formed in the side of the pouch 102, 104, 106, allowing a user to tear open the pouch 102, 104, 106 by pulling on the side of the pouch at the location of the notch 212. Thus, during use, a technician can tear open the pouch 102, 104, 106 by pulling along the tear line to access the pre-moistened wipes contained therein.

[0033] In order for the deactivated wipe kit 100 to be introduced into a cleanroom, it (and its contents) must first be sterilized. In one embodiment, multiple parts of the deactivated wipe kit 100 are irradiated to prevent the introduction of contaminants into the controlled environment. The second pouch 104 and the third pouch 106 contain chemicals that may be terminally sterilized by methods such as those described herein. Thus, the assembled pouches 104, 106 may undergo known terminal radiation sterilization. However, the first pouch 102 contains a chemical (i.e., sodium hypochlorite) that cannot be terminally sterilized by radiation. Unlike the second pouch 104 and the third pouch 106, the first pouch 102 is configured so that chemicals can be added after the first pouch 102 has been sterilized.

[0034] As shown in FIG. 2, the first pouch 102 is designed with a one-way valve 208 located at one end 210, allowing the pouch 102 to contain wipes 209. This valve 208, shown in more detail in FIGS. 3A-3E, allows fluid to pass through in only one direction. Thus, the first pouch 102, containing only dry wipes, may undergo terminal radiation sterilization along with the second pouch 104 and the third pouch 106 (each containing a wipe and its respective chemical). Then, when the pouches 102, 104, and 106 are transferred to a cleanroom, the first pouch 102 may be aseptically filled with a sterilized hypochlorite solution through the one-way valve 208, wetting the dry wipes contained therein. The sterilized hypochlorite solution may be of any concentration as determined by one skilled in the art. For example, a 5.25% hypochlorite concentration may be used. At this stage, the deactivated wipes kit 100 is fully ready for use in a cleanroom. Wipes for the kit may be of conventional known sizes, typically either 3"x4", 4"x6", 9"x9", 9"x12" or 12"x12".

[0035] The process for preparing the deactivated wipe kit 100 is outlined in the flowchart of Figure 4. Each pouch 102, 104, 106 may be prepared sequentially or simultaneously by different technicians. Thus, steps 400, 402, 404 may be performed sequentially or simultaneously. As described in more detail below, each step utilizes the chemicals and materials described above.

[0036] In step 400, dried wipe material is placed in a first pouch 102 and hermetically sealed to form a first hermetically sealed container or pouch. No chemicals are placed in the first pouch 102 at this stage. Wipes saturated with a first solution, e.g., a thiosulfate solution (e.g., THIO-WIPE™), are placed in a second pouch 104 and hermetically sealed to form a second hermetically sealed container or pouch (step 402). Wipes saturated with a second solution, e.g., 70% IPA (e.g., ALCOH-WIPE™), are placed in a third pouch 106 and hermetically sealed to form a third hermetically sealed container or pouch (step 404). In step 406, each of the pouches 102, 104, and 106 are hermetically sealed, covering the contents of each pouch. In one embodiment, the hermetic sealing, such as heat sealing, provides a liquid-tight and air-tight seal to the pouches 102, 104, 106. Although the heat sealing of step 406 is shown as a separate step, it may be part of each of the filling processes of steps 400, 402, and 404.

[0037] In step 408, the first, second, and third sealed pouches 102, 104, and 106 are assembled (assembled) in preparation for radiation sterilization. In step 410, the first, second, and third sealed pouches 102, 104, and 106 are individually assembled and placed in a first container, such as a first plastic bag, which is then hermetically sealed to form a first hermetically sealed or sealed pouch enclosure. As another example, the first sealed pouch enclosure may be placed in a second container, such as a second plastic bag, which is then hermetically sealed to form a second hermetically sealed or sealed pouch enclosure. In one embodiment, the first and second plastic bags are heat-sealed polyethylene bags. The second (or first) sealed pouch enclosure is then placed in a plastic liner bag (e.g., a polyethylene bag), which is then closed and placed in a box or other container. In step 412, the liner is closed (by tying or zipper closure) and the box it is contained in is closed to form a sealed package. In step 414, the box and its contents are terminally sterilized by radiation using known techniques and equipment and may be transferred to a radiation irradiator for sterilization, forming a sterilized, sealed container. The radiation sterilizes the containers and contents, including the plastic bags, wipes, pouches, and solutions described above.

[0038] These irradiated boxes (sterilized and sealed containers) are then transferred to a clean environment, where the sterilized and sealed pouch enclosures are removed from the plastic liner bags. In step 416, the sterilized first, second, and third sealed pouches are removed from the innermost sealed plastic bag. 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 a deactivating chemical. In one embodiment, in step 418, the first sealed pouch 102 is aseptically filled with a sterile hypochlorite solution through the one-way valve 208 in a clean room. At this stage, once the first pouch 102 is filled with the solution, the solution wets the dry wipes within the pouch 102, thereby preparing the wetted hypochlorite wipes. Valve 208 is designed to self-seal, but other suitable valve designs may also be provided.

[0039] When the valve 208 closes, the first sealed pouch 102 becomes a first sealed or sealed filled pouch and is ready for use. As another example, the first sealed and filled pouch 102 may be further sealed in a first container, such as a plastic bag, which may be successively hermetically sealed in a second container, such as a plastic bag, to form a first or second filled pouch enclosure. Once the first sealed and filled pouch 102 (or first / second filled pouch enclosure) is ready for use, the deactivated wipe kit 100 is formed by combining one of the irradiated second sealed pouches 104 with one of the irradiated third sealed pouches 106. As another example, the deactivated wipe kit 100 may be hermetically heat-sealed to a first container (e.g., a polyethylene bag), which may be successively hermetically heat-sealed to a second container (e.g., a polyethylene bag), such as a plastic bag. Multiple wipe kits 100 may be placed together in a carton with a plastic liner that can be closed (by tying or with a zipper) and a box closed to form the final closed package, which can then be shipped to customers for use.

[0040] Alternative processes for preparing the deactivated wipe kit 100 are possible. The placement of the dry, wiping material into the first pouch 102 (step 400) may occur before, during, or after the placement of the thiosulfate-soaked wipes into the second pouch 104 (step 402), and before, during, or after the placement of the IPA-soaked wipes into the third pouch 106 (step 404). Similarly, the placement of the thiosulfate-soaked wipes into the second pouch 104 (step 402) and the IPA-soaked wipes into the third pouch 106 (step 404) may occur in any order with respect to the creation of the other pouches, provided that all three pouches 102, 104, and 106 are prepared before the heat-sealing step, provided they are packaged together in the same box. Alternatively, the irradiated second and third pouches may be packaged together in a separate box from the first final pouch.

[0041] Additionally, other suitable techniques may be utilized to radiation sterilize the pouches 102, 104, 106. For example, multiple pouches 102, 104, and / or 106 may be heat-sealed within the same or different individual first (and optionally second) plastic bags. In one embodiment, each sealed pouch 102, 104, 106 may be individually single / double bagged (i.e., heat-sealed within a first plastic bag (and optionally further within a second plastic bag) to provide sealed first and second enclosures for the first, second, and third sealed pouches, respectively), and then placed in a carton liner and box for sterilization. In another embodiment, a plurality of first sealed pouches 102 may be placed in a first bag and heat sealed together to form a first enclosure, a plurality of second sealed pouches 104 may be placed in a second bag and heat sealed together to form a second enclosure, a plurality of third sealed pouches 106 may be heat sealed in a third bag to form a third enclosure, and the first, second and third enclosures may be placed in a liner and box and irradiated simultaneously.

[0042] Furthermore, the first sealed pouches 102 may be individually single- or double-bagged and placed in a first box, the second sealed pouches 104 may be individually single- or double-bagged and placed in a second box, and the third pouches 106 may be individually single- or double-bagged and placed in a third box. Alternatively, the first sealed pouch enclosures may be placed in a single first box for irradiation, and the second and third pouch enclosures may be placed together in a single second box for irradiation. Furthermore, the first and second containers may be any suitable containers, such as pouches, and the first, second, and third pouches 102, 104, 106 may be any suitable containers.

[0043] In this manner, an end user can receive a single box containing multiple kits, each kit having a first, second, and third sterile, sealed pouch. The method of use of the deactivating wipe kit 100 is outlined in FIG. 5. When the box arrives at the customer's location, the box and box liner are opened (e.g., in a clean room or temporary storage location (staging area)). One kit 100 may be removed from the box and taken to the clean room for use. The heat-sealed bag is opened, and the pouches 102, 104, and 106 are removed. As shown in step 500, the first pouch 102 is opened (e.g., by tearing perforation line 212) and the hypochlorite-impregnated wipe is removed. The wipe is then used to wipe a contaminated work surface (preparation surface, preparation table) to deactivate one or more harmful agents in step 502. Next, in step 504, the second pouch 104 is opened and a thiosulfate-impregnated wipe is removed. Next, in step 506, the work surface that was just treated with the hypochlorite-impregnated wipe is used to decontaminate the surface and remove any hypochlorite residue that may still be present on the surface. Next, in step 508, the third pouch 106 is opened and an IPA-impregnated wipe is removed. Finally, in step 510, the wipe is used to wipe the work surface, disinfecting and cleaning the surface and making it safe for use by the technician or operator. Successive uses of each wipe on the surface inactivate (deactivate) and decontaminate any harmful chemicals present, disinfecting and cleaning the surface and making it safe for use by the technician.

[0044] As described, it will be apparent that the present invention may take several different forms within its scope. The first, second, and third pouches may be individually single / double bagged (i.e., hermetically sealed to the first pouch and then to the second pouch). Alternatively, the second and third pouches may be single / double bagged together for irradiation and delivery to the end user, housed together in a single box with the double-bagged first filled pouch enclosure, or boxed separately from the single / double bagged first filled pouch enclosure. Still other variations are possible within the spirit and scope of the present invention. For example, an end user may receive a first box containing a plurality of first sterilized and sealed pouches and a second box containing a plurality of second and third sterilized and sealed pouches. Furthermore, while the present invention describes the use of three pouches, each containing a different solution, other suitable numbers of pouches and solutions, such as two, four, or more, may also be used.

[0045] For example, further illustrative, non-limiting examples of the present invention are shown in FIGS. 6 and 7 , which illustrate an alternative embodiment of a first pouch 250. The pouch 250 has two polyethylene layers 270, 272 that are heat-sealed at their edges (either directly to each other in the example shown in FIG. 7 or via a sidewall therebetween in the example shown in FIG. 6 ) to define an interior space 274 therebetween. The pouch is substantially rectangular and has two longitudinal sides and two transverse sides substantially perpendicular to the longitudinal sides. A transverse coupling assembly (connection assembly, coupling assembly, connection), e.g., a frangible seal 260, is provided in the center to form a first compartment 252 and a second compartment 254. The first compartment 252 has a first layer 270a, a second layer 272a, and an interior space 274a therebetween, and the second compartment 254 has a first layer 270a, a second layer 272a, and an interior space 274b therebetween. The frangible seal 260 is substantially parallel to the lateral sides and extends the entire width of the pouch 250. The first and second compartments 252, 254 are completely liquid-tight, meaning that liquid cannot pass from the first compartment 252 to the second compartment 254 or vice versa.

[0046] In construction, the pouch 250 is formed by heat-sealing the layers 270, 272 along their two longitudinal sides (either directly to each other in the example shown in FIG. 7 or via the sidewall therebetween in the example shown in FIG. 6 ) and then applying a frangible heat seal 260. A dry wiper 256 is then placed within the interior space 274b of the second compartment 254, and the bottom lateral edges are heat-sealed to completely enclose the wiper 256 within the second compartment 254. A laser score 262 may be formed along at least a portion of the second compartment 254 and is shown here extending laterally across the entire width of the pouch 250. Additionally, a valve 258 is positioned along the top lateral edges, and the entire top lateral edges of the two layers 270, 272 are heat-sealed to sandwich the valve 258 to the top of the first compartment 252. The entire pouch 250 is then sterilized by irradiation.

[0047] At this point, the interior space of first compartment 252 is filled with a liquid via valve 258. In one embodiment, the liquid is a disinfectant, such as bleach, which is filtered and aseptically filled into first compartment 252 in a clean room. Pouch 250 is then packaged and delivered to the clean room for use, for example, double-bagged in two consecutive polyethylene bags, placed in a plastic liner, and then placed in a cardboard box for shipping.

[0048] The frangible (breakable, rupturable) frangible seal 260 is weaker than the peripheral heat seal. The frangible seal 260 can be formed, for example, by bonding with lower heat. To use the wiper 256, a user opens the outer package. The user then applies pressure to the first and / or second compartments 252, 254, thereby breaking the frangible seal 260. The interior spaces 274a, 274b of the first and second compartments 252, 254 are then in fluid communication with each other, and breaking the seal 260 releases liquid from the first compartment 252 into the second compartment, where it comes into contact with the one or more wipers 256 in the second compartment. The frangible (frangible) seal 260 does not weaken the outer plastic layer forming the pouch 250, making the pouch 250 liquid-resistant and preventing liquid from leaking from the pouch 250. Once the liquid is absorbed by the wiper 256, the user opens the second compartment 254 along the laser score 262. The user then removes the wet wiper 256 from the interior space 274 for use in the clean room.

[0049] In this way, liquids do not come into contact with the wiper 256 until the wiper 256 is about to be used, which is important because liquids (e.g., bleach) could otherwise degrade the wiper 256. This extends the shelf life of the product. Additionally, while the pouch 250 can be formed in any suitable manner, the frangible heat seal 260, score 262, and two longitudinal seals can be formed before the wiper 256 is introduced, and these processes can prevent the wiper 256 from being inadvertently sealed together or damaged. However, in another embodiment, the bottom lateral edge and two longitudinal edges can be heat sealed. The wiper 256 can then be placed within the pouch 250, and the frangible heat seal 260 and top lateral heat seal can be applied. In another embodiment of the present invention, the wiper 256 may be placed between the two layers 270, 272 and then heat sealed to the frangible seal 260, including along the longitudinal edges and the top and bottom lateral edges, to form all seals simultaneously.

[0050] The dual-compartment pouch 250 of Figure 6 with two compartments 252, 254 can be used with the second pouch 104 and the third pouch 106 in the systems and methods described with reference to Figures 1-5. For example, the pouch 250 with the dry wiper 256 can be used with the second pouch 104 and the third pouch 106. However, the dual-compartment pouch 250 of Figure 6 also has separate utility and can be used in other suitable applications, without being used with the second and third pouches 104, 106. For example, the pouch 250 can be used alone if only a single wiper is needed.

[0051] It is further noted that the present invention is shown and described as a pouch 250 having two compartments 252, 254 separated by a frangible, frangible seal 260. The two compartments 252, 254 are directly attached to one another and separated by the frangible seal 260 such that when the seal 260 is opened, the compartments 252 and 254 are in fluid communication with one another. It should be noted that within the spirit and scope of the present invention, the two compartments can be placed in communication with one another in other ways without the use of a frangible seal, for example, by using a valve or other connecting device or coupling assembly.

[0052] Additionally, it should be noted that frangible seal 260 is shown as extending across the entire width of pouch 250. Friable seal 260 need not extend across the entire width. For example, a portion of seal 260 may be a complete heat seal that permanently separates first compartment 252 from second compartment 254, and a portion of seal 260 may be openable as a frangible seal to release liquid from first compartment 252 to second compartment 254.

[0053] Additionally, as shown in FIG. 7 , the friable seal 260 may directly seal the first layer 270 to the flat second layer 272, bringing the two layers 270, 272 together at the seal. Thus, the first layer 270 is directly sealed to the second layer 272 without any other material disposed therebetween. In this manner, the seal 260 forms a tapered region between the first compartment 252 and the second compartment 254. The seal 260 may have any suitable thickness, be small enough to form a line or pinch point, or wide enough to form a flat region. In one embodiment, the seal 260 may have a thickness of approximately 0.3125 inches, the first compartment may have a length of approximately 5.3125 inches, the second compartment may have a length of approximately 6.375 inches, and the pouch may be approximately 4.5 inches wide and approximately 12 inches long. The first compartment can contain approximately 30 mL of liquid or solution, and the second compartment can contain one or more folded 12x12 woven (knit) wipes. Furthermore, the seal 260 need not be straight as shown, but can be other shapes, such as curved. In alternative embodiments of the present invention, the first compartment 252 can be the same size as the second compartment 254, or a different size, smaller or larger than the second compartment 254. The first and second compartments can be generally square or rectangular, or any other suitable size and shape.

[0054] As previously mentioned, FIG. 7 shows that the longitudinal sides of the first and second layers 270, 272 are heat-sealed directly to one another. And, FIG. 6 shows that the pouch 250 has sidewalls extending between the longitudinal (lengthwise) sides of the first layer 270 and the second layer 272 relative to the first compartment 252 and / or the second compartment 254. The sidewalls allow the layers 270, 272 to separate at the longitudinal sides, thereby retaining more liquid, substance, or product within the compartments 252, 254. The sidewalls are heat-sealed to the first and second layers 270, 272. For example, the sidewalls may be substantially rectangular, with a first longitudinal side joined to the first layer 270 and a second longitudinal side joined to the second layer 272, and may be tapered, either partially or elliptically. The pouch 250 may have one side wall on each longitudinal side and may be sealed in the middle by a frangible seal 260, or may have two longitudinal sides, one side for the first compartment 252 and one side for the second compartment 254. During manufacture, the sides may be heat sealed to the layers 270, 272 in a single heat sealing process, where each longitudinal edge of the side wall is heat sealed at once, or in an overlapping heat sealing process, where the first longitudinal edge is heat sealed first and then the second longitudinal edge.

[0055] In yet another embodiment, the pouch may include additional lateral frangible seals to define two or more liquid-tight compartments within the pouch. For example, a first compartment may contain a first product (e.g., dry wipes), liquid, or substance, a second compartment may contain a second product, liquid, or substance, and a third compartment may contain a third product, liquid, or substance. These compartments may be arranged such that, when the frangible seals are broken, they all communicate with each other, or the second compartment may be positioned between the first and second compartments, with the first and third compartments communicating with only the second compartment. The frangible seals may then have different break points and may be broken separately, for example, a first frangible seal may be broken to release the contents from a first compartment to a second compartment, and then a second frangible seal may be broken to release the contents from the first and second compartments to a third compartment.

[0056] Referring to Figures 8-9, one embodiment of the present invention is shown. Pouch 300 has a pouch body 310 formed by a first layer 301 and a second layer 303. Pouch 300 has a peripheral seal and an inner seal. The peripheral seal is on the longitudinal and transverse sides and forms a first longitudinal side or wall 305, a second longitudinal side or wall 307, a top or upper wall 309, and a bottom or lower wall 311, which define the periphery of pouch 300. The pouch is substantially rectangular in shape, whereby top and bottom ends 309, 311 are transversely perpendicular to first and second longitudinal sides 305, 307.

[0057] The inner seal is a coupling assembly that includes an inner transverse seal 313 and an inner compartment seal 315. The inner 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 inner transverse seal 313 is closer to the upper end 309 of the pouch than the lower end 311 of the pouch. The inner transverse seal 313 is substantially parallel to the upper and lower ends 309, 311 of the pouch. The inner compartment seal 315 extends substantially parallel to the longitudinal sides 305, 307 from approximately the center of the inner transverse seal 313 to the upper end 309 of the pouch, thereby making the third compartment 340 longer than the first and second compartments 320, 330.

[0058] The multiple interior seals and multiple peripheral seals together form various interior compartments of the pouch 300. In the illustrated embodiment, the multiple interior seals form a first compartment 320 having a first interior space, a second compartment 330 having a second interior space, and a third compartment 340 having a third interior space. The first compartment 320 holds a first chemical, such as bleach, in the first interior space and is defined by the first longitudinal seal, the top seal, the interior transverse seal 313, and the interior compartment seal 315. The second compartment 330 holds a second chemical, such as WFI, in the second interior space. In this manner, the first and second chemicals are kept separate from each other during manufacturing, shipping, and storage and can be combined immediately prior to use, avoiding degradation of the chemicals prior to use and increasing shelf life.

[0059] In the illustrated embodiment, the inner compartment seal 315 is centered between the inner lateral seal 313 and the top edge 309, resulting in equal sized first and second compartments 320, 330. However, the inner compartment seal 315 may be located closer to one of the longitudinal sides 305, 307, and the first and second compartments 320, 330 may be unequal in size. Furthermore, other interior seals defining additional compartments may be provided. And, while the compartments 320, 330, 340 are shown side-by-side, a compartment may be formed entirely within another compartment. While the inner seals 313, 315 are shown contiguous, the seals may be located in any suitable location and need not be contiguous. Thus, a wide variety of compartment configurations are possible.

[0060] 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. These valves 312, 314 are one-way and allow liquid to fill the first and second interior spaces of the first and second compartments 320, 330. Although the valves 312, 314 are shown at the top end 309 of the pouch, the valves may be provided elsewhere, such as on either the front (i.e., formed in the first layer 301) and / or back (i.e., formed in the second layer 303) of the pouch.

[0061] The first and second seals 315, 313 can be configured to be broken (or torn) separately; for example, the first seal 315 can be broken without breaking the second seal 313. For example, the first seal 315 can be weaker than the second seal 313. Alternatively, the first seal 315 can be positioned sufficiently far from and / or at a different angle (diagonal) relative to the second seal 313. Thus, a user can grasp a portion of the pouch body 310 adjacent to each seal 315, 313 to selectively break the first seal 315 without breaking the second seal 313, thereby combining the bleach contained in the first compartment 320 with the WFI contained in the second compartment 330 and allowing the bleach and WFI to mix with each other. The user can then subsequently break the second seal 313 to release the combined bleach and WFI onto the dry wipe 302.

[0062] The third compartment 340 holds an item, such as a wipe 302, in the third interior space. The compartments 320, 330, and 340 are liquid-tight and separated from one another. In this manner, the third compartment 340 is kept separate from the liquids in the first and second compartments 320 and 330, thereby keeping the wipe dry during manufacturing, shipping, and storage. The liquids are mixed and introduced into the dry wipe 302 immediately before use, preventing deterioration of the wipe 302 and extending its shelf life. When the pouch 310 is in use, the inner seals 313 and 315 are opened, allowing the wipe 302 to be saturated with the liquids contained in the first and second compartments 320 and 330 to inactivate and / or decontaminate hazardous substances and disinfect work surfaces in a cleanroom environment. It should be noted that some or all of the sides or ends of each of the pouches and compartments may be constructed with walls.

[0063] The third compartment 340 is provided with an access opening or cover 304 through which the wipes 302 can be removed for use (ready for use). In the embodiment shown in FIGS. 8 and 9, the cover 304 is a press-and-seal cover. An opening 308 is formed in the upper layer 301 of the third compartment 340. The cover 304 is larger than the opening 308 and fits over and around the opening 308. The cover 304 includes an access tab 306 that can be opened by a user and then closed and resealed. Thus, when a user wants to remove the wipes, the user opens the third compartment 340 by peeling back the access tab 306, exposing the moistened wipes 302. The user can then remove the desired number of wipes by pulling wipes 302 through the opening 308 and through the open access tab, and then seal the third compartment 340 by pushing the access tab 306 back into place.

[0064] In a different embodiment, the peel-and-seal cover 304 may not be provided. Instead, the user may access the wipes 302 by providing a notch or perforation in the side 342 of the third compartment 340. A notch may be formed in the side 342 of the third compartment 340, allowing the user to tear the third compartment 340 by pulling on the side of the pouch at the notch. Thus, during use, a technician can pull the pouch along the perforation to tear the two layers of the pouch apart and access the moistened wipes contained therein.

[0065] Thus, first compartment 320 has a bottom side or edge 321 formed by inner lateral seal 313, a first longitudinal side 322 formed by a portion of pouch first longitudinal side 305, a top side or edge 323 formed by a portion of pouch top edge 309, and a second longitudinal side 324 formed by inner compartment seal 315. As further shown, inner compartment seal 315 can be formed as a burst seal or frangible seal configured to open when a user applies a certain amount of pressure to seal 315. The frangible seal can be the entire inner compartment seal 315, or, as shown, can consist of only a portion of inner compartment seal 315 being frangible. The inner compartment seal 315 may form the entire second longitudinal sidewall 324 or, as shown, may form only a portion of the second longitudinal sidewall 324 .

[0066] Second compartment 330 has a bottom or end 331 formed by inner compartment seal 315, a first longitudinal side 332 formed by inner compartment seal 315, a top or end 333 formed by a portion of top edge 309, and a second longitudinal side 334 formed by a portion of pouch second longitudinal side 307. Third compartment 340 has a bottom or end 341 that is bottom end 311 of the pouch, a first longitudinal side 342 formed by a portion of pouch first longitudinal side 305, a top end or side 343 formed by inner lateral seal 313, and a second longitudinal side 344 formed by a portion of pouch second longitudinal side 307. Thus, the first side 305 of the pouch forms the first longitudinal sides 322, 342 of the first and third compartments 320, 340, the second longitudinal side 307 of the pouch forms the first longitudinal sides 334, 344 of the second and third compartments 330, 340, and the top end 309 of the pouch forms the top ends 323, 333 of the first and second compartments 320, 330. The inner lateral seal 313 can form the entire bottom 331, or, as shown, can form only a portion of the bottom 331.

[0067] Before pouch 300 can be introduced (loaded) into a cleanroom, it must first be sterilized (and its contents). In one embodiment, a portion (or portions or components) of pouch 300 is irradiated to avoid introducing contaminants into the environment. Wipes 302 and the WFI in second compartment 330 may be terminally sterilized by irradiation, such as by methods described herein. Thus, pouch 310 may undergo known terminal irradiation sterilization. However, first compartment 320 cannot be terminally sterilized by irradiation because it contains a chemical (i.e., bleach). Thus, pouch 310 is configured to allow chemicals to be added to first compartment 320 (and optionally, to WFI in second compartment 330) after wipes 302 in third compartment 340 have been sterilized.

[0068] The pouch 300 is designed with first and second one-way valves 312, 314 located at the top ends 323, 333 of the first and second compartments 320, 330, respectively. These valves 312, 314 allow fluid to be transferred in only one direction through them. Thus, the pouch 300, with only the dry wipes 302 in the third compartment 340 or additionally with WFI in the second compartment 330, can undergo terminal irradiation sterilization. Subsequently, after transporting the pouch 300 to a clean room, the first compartment 320 may be aseptically filled with sterilizing bleach through the first one-way valve 208 to infiltrate the dry wipes contained therein. The sterilizing bleach solution may be of any concentration deemed appropriate by one skilled in the art. At this point, the pouch 300 is fully ready for use in a clean room. The wipes for incorporation may be of any conventional known size, such as, for example, 3 inches by 4 inches, 4 inches by 6 inches, 9 inches by 9 inches, 9 inches by 12 inches, or 12 inches by 12 inches.

[0069] The process for preparing pouch 300 is outlined here. The steps can be performed sequentially or simultaneously. As described in more detail below, each step utilizes the chemicals and materials described above. Layers 301, 303 of pouch body 310 are hermetically heat-sealed along left and right sides 322, 342, 334, 344, top 323, 333, and bottom 341, as well as interior walls 321, 324, 331, respectively, to form the pouch's respective sides and compartments. First and second ports 312, 314 are integrally sealed to the top edges 323, 333 of first and second compartments 320, 330, respectively. First and second burst seals 315, 313 are then formed in pouch body 310.

[0070] At this stage, the right side 344 of the third compartment 340 has an opening 345, allowing a dry wipe 302 to be placed into the third compartment 340. The right side of the third compartment 340 is then hermetically sealed to form a hermetically sealed third compartment. At this point, there are no chemicals within the pouch 300. Optionally, WFI can be loaded into the second compartment through the second port 314 at this point. 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, and the first plastic bag can be hermetically sealed to form a first hermetically sealed pouch enclosure. Optionally, the first hermetically sealed pouch enclosure can be placed in a second container, such as a second plastic bag, which is then hermetically sealed to form a second hermetically sealed pouch enclosure. In one embodiment, the first and second plastic bags are polyethylene bags that are heat-sealed. The second (or first) sealed pouch enclosure is then placed into a plastic liner bag (e.g., a polyethylene bag), and the liner is closed and placed into a box or other container. The liner is then closed (by tying or with a zipper), and the box is closed to form a closed package. The box and enclosed contents can then be terminally irradiated and shipped to an irradiator for sterilization, forming a sterile, sealed container, using known techniques and equipment. Irradiation sterilizes the container and its contents (including the plastic bag, wipes, pouch, and solution).

[0071] The irradiated box (sterilized and sealed container) is then transferred to a clean environment, and the sterilized and sealed pouch enclosure is removed from the plastic liner bag. The sterilized pouch 300 is then removed from the innermost sealed plastic bag. At this time, in the clean room, bleach is aseptically filled into the first compartment 320 through one-way valve 312. Also, if the second compartment 330 has not previously been filled with WFI, it can be filled through second port 314 at this time. These valves 312, 314 are self-sealing by design, although other suitable valve designs may be provided.

[0072] When the valves 312, 314 are closed, the pouch 300 is hermetically sealed, forming a filled pouch, which is then ready for use. Optionally, the pouch 300 may be hermetically sealed to a first container, and optionally, successively to a second container, such as a plastic or polyethylene bag, forming the first (and second) filled pouch enclosure. Multiple wipe pouches 300 are then placed together in a carton with a plastic liner. The plastic liner can be closed (such as by tying or with a zipper), and the box is closed to form the final closed package. The box can then be shipped to a customer for use.

[0073] Also, different steps for preparing the pouch 300 can be performed. For example, heat sealing and burst sealing can be performed in any order. It will be further understood that other suitable techniques can be utilized 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 / double bagged (i.e., heat-sealed in a first plastic bag (and optionally a consecutive second plastic bag) to form first and second sealed enclosures for the first, second, and third closed pouches, respectively), and then placed in a carton liner and box for sterilization.

[0074] Here is an overview of how the pouch 300 is used. When the box arrives at the customer, the box and box liner are opened (e.g., in a clean room or temporary storage location (staging area)). The pouch 300 can then be removed from the box and taken to the clean room for use. The heat-sealed bag is opened and the pouch 300 is removed. The user then breaks the first burst seal 315 between the first and second compartments 320, 330 and introduces the bleach into the WFI. Once the bleach and WFI are mixed, the user breaks the second burst seal 313 between the second and third compartments 330, 340 and directs the bleach / WFI mixture into 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 tab 306 or tearing the perforations) and removes the wipe saturated with the diluted bleach. This wipe is then applied to the contaminated work surface to clean the hazardous agent or agents.

[0075] The first, second, and third compartments 320, 330, 340, including all peripheral and internal seals, are completely liquid-tight, preventing liquid from passing from the first compartment 320 to the second compartment 330, or vice versa, or otherwise leaking from the pouch 300. Furthermore, liquid cannot enter the third compartment 340 from either the first or second compartments 320, 330.

[0076] The burst seals 315, 313 are more fragile or weaker than the peripheral heat seals on the longitudinal sides 305, 307 and the top and bottom 309, 311. The frangible seals 315, 313 can be formed, for example, by bonding at a lower heat, such that the first burst seal 315 is bonded at a lower heat than the second burst seal 313, thereby making the first burst seal weaker than the second burst seal. To use the wiper 302, a user opens the outer envelope. The user then presses on the first and / or second compartments 320, 330, which breaks the first frangible seal 315. This places the internal spaces of the first and second compartments 320, 330 in liquid communication with each other, such that when the seal 315 is broken, liquid is released from the first compartment 320 into the second compartment 330 and comes into contact with the liquid in the second compartment 330.

[0077] The user then presses against the second or third compartment 330, 340, which breaks the second frangible seal 313. The interior spaces of the second and third compartments 330, 340 are now in liquid communication with each other, thereby breaking the seal 313 and releasing liquid from the first and second compartments 320, 330 into contact with the wiper in the third compartment 340. Because the frangible (breakable) seals 315, 313 do not weaken the outer plastic layer forming the pouch 310, the pouch 310 is liquid-proof and liquid will not leak outside the pouch 310. Once the liquid is absorbed by the wiper 302, the user opens the third compartment 340 with the press-seal cover 304. The user then removes the wet wiper 302 from the interior spaces for use in the cleanroom.

[0078] In this way, liquids do not come into contact with the wiper 302 until it is about to be used, which is important when liquids (such as bleach) could otherwise degrade the wiper 302. This extends the shelf life of the product. Furthermore, while the pouch 300 can be formed in any suitable manner, it should be noted that the frangible heat seals 315, 313 and perimeter seal can be applied prior to the introduction of the wiper 302 to prevent the wiper 302 from being inadvertently caught or otherwise damaged during any of these operations. However, in another embodiment, the bottom lateral and two longitudinal sides can be heat sealed. The wiper 302 can then be placed within the third compartment 340, and the frangible heat seals 315, 313 and top lateral heat seal applied. In another embodiment of the present invention, the wiper 302 can be placed between two plastic layers, and then all seals, including the frangible seals, along the longitudinal sides, and the top and bottom lateral sides, can be formed simultaneously.

[0079] It is further noted that the present invention is shown and described as a pouch 300 having compartments 320, 330, 340 separated by frangible seals 315, 313. Because compartments 320, 330, 340 are directly attached to one another and separated by frangible seals 315, 313, compartments 320, 330, 340 are in fluid communication with one another when seals 315, 313 are opened. It is noted that compartments can be arranged to communicate with one another in other ways without the use of frangible seals, such as by using valves or other connecting devices or coupling assemblies, within the spirit and scope of the present invention.

[0080] Additionally, while both the first and second compartments 320, 330 are shown with ports 312, 314, only one of the compartments may have a port. For example, the second compartment 330 contains WFI and may therefore be irradiated. In one embodiment, the WFI may be filled into the second compartment 330 as the compartment is formed, eliminating the need for a port and allowing the WFI to be irradiated at the same time the dry wipes 302 are irradiated. The first port 312 may be used to aseptically fill the first compartment 320 with bleach, which cannot be irradiated.

[0081] Further, note that a frangible seal 315 is disposed between the first and second compartments, but no frangible seal exists between the first and third compartments. Rather, the seal 313 between the first and second compartments does not rupture during use and remains intact and unruptured during use. In this manner, the chemicals in the first and second compartments can be mixed together before being introduced to the wipe 302 in the third compartment. Furthermore, there is no direct liquid flow communication between the first and third compartments 320, 340. Rather, the liquid in the first compartment 320 cannot reach the third compartment 340 without first flowing through the second compartment 330. Bleach, the most degradable chemical, is contained in the first compartment 320 so as not to degrade the wipe 302 if the second frangible seal 313 ruptures simultaneously with or before the first frangible seal 315.

[0082] Furthermore, the first layer 301 and the second layer 303 are directly sealed together without any other material disposed therebetween. In this manner, the frangible seals 315, 313 form tapered regions between the compartments 320, 330, and 340. The seals 315, 313 may be of any suitable thickness, e.g., small enough to form a line or pinch point, or wide enough to form a flattened region. In one embodiment, the pouch 300 may have a length of 13.5 inches and a width of 11.81 inches, the first compartment may have a length of approximately 5 inches, and the third compartment may have a length of approximately 8.5 inches. The first and second compartments may each hold approximately 170 mL of liquid or solution, and the third compartment may hold one or more folded 12x12 knit wipes. Furthermore, the seals need not be straight, as shown, but may have other shapes, such as curved. In another embodiment of the invention, the first compartment may be the same size as the second compartment or may be a different size, e.g., smaller or larger than the second compartment. The first, second, and third compartments may be generally square or rectangular, or may have other suitable sizes and shapes.

[0083] 10-14 show another exemplary embodiment of the present invention. Here, the two upper compartments are shown to have different sizes. The upper left compartment is larger than the upper right compartment but smaller than the lower compartment. The upper left and upper right compartments have the same height, but the left compartment is wider than the right compartment. This allows, for example, the left compartment to hold a dilute liquid such as water for injection (WFI), while the right compartment holds a concentrate such as bleach. In one embodiment, the size and dimensions are as shown in FIG. 14. To use, the user rolls the pouch from the upper left corner, pushing the liquid in the upper left compartment toward the right and increasing the pressure in the upper left compartment. The pressure eventually builds until the breakable or burst seal between the two upper compartments breaks, releasing the WFI into the concentrate.

[0084] Thus, the liquids are mixed together by squeezing the pouch. Once they are sufficiently mixed, the user can roll the pouch from the top left corner or from the top until the burst seal between the top right compartment and the bottom compartment breaks, releasing the mixed composition into the bottom compartment. The mixed composition then contacts and wets the wiper. The wiper can then be removed by opening the upper access tab 306. Figures 10-14 are an example embodiment; the compartments may be of other relative sizes, shapes, and dimensions, and any number of compartments may be provided.

[0085] FIG. 15 illustrates another embodiment of a pouch. Here, the pouch is similar to the embodiment of FIGS. 6 and 7. Tabs 382, ​​384 extend inward from each of the two longitudinal sides 307. An internal burst seal extends laterally between the two tabs 382, ​​384 and connects to the inner tips of the two tabs 382, ​​384. The tabs 382, ​​384 may be relatively short, substantially shorter than the burst seal 380, so that the burst seal 380 extends approximately the full width of the pouch, allowing unhindered movement of liquid from the upper compartment to the lower compartment upon seal rupture. However, in other embodiments, the tabs 382, ​​384 may be longer, and the tabs 382, ​​384 may be the burst seal 380.

[0086] The pouch of Figure 15 does not include tear lines or scores 262 for removing wipes, as in Figures 6 and 7. Instead, it has a peel-and-seal type opening cover 304 (similar to cover 304 in Figure 8). Also, it does not have the opening 345 of Figure 8. Instead, the right longitudinal side 307 is continuous and heat sealed, and the bottom edge 311 is open between layers 301, 303 and is heat sealed when a wipe is placed in the bottom compartment.

[0087] Finally, please note that the present specification and claims use a number of geometric or relational terms, such as parallel, straight, curved, rectangular, vertical, and planar. The specification and claims also use a number of directional or positioning terms, such as top, bottom, edge (side), longitudinal (longitudinal), lateral, and interior. These terms are merely for convenience to facilitate description based on the illustrated embodiments. These terms are not intended to limit the present invention. It will be understood, therefore, that the present invention may be described in other ways without using these geometric, relational, directional, or positioning terms. Furthermore, the geometric and relational terms may not be precise. For example, walls may be considered substantially perpendicular or parallel to one another even if they are not precisely perpendicular or parallel to one another due to, for example, surface roughness or manufacturing tolerances. Other suitable geometric shapes and relationships may be provided without departing from the spirit and scope of the present invention.

[0088] While the present invention has been described with reference to particular forms and embodiments thereof, it will be understood that various modifications other than those described above are possible without departing from the spirit or scope of the invention. For example, equivalent elements may be substituted for those specifically shown and described, certain features may be used independently of other features, and in some cases certain positions of elements may be reversed or interleaved, all within the scope of the invention as defined in the appended claims.

Claims

1. a first compartment containing a first chemical; a second compartment containing a second chemical; a third compartment containing dry wipes; a first coupling assembly connecting the first compartment and the second compartment, the first coupling assembly including a closed configuration in which the first compartment does not communicate with the second compartment and an open configuration in which the first compartment communicates with the second compartment; a second coupling assembly that couples the second compartment and the third compartment, the second coupling assembly including a closed configuration in which the second compartment does not communicate with the third compartment and an open configuration in which the second compartment communicates with the third compartment; the first compartment, the second compartment, and the third compartment are disposed side by side with one another; and A wipe pouch having a wall between the first compartment and the third compartment configured to hermetically seal the first compartment and the third compartment and prevent communication between them, wherein the first compartment communicates with the third compartment only via the second compartment.

2. In claim 1, The pouch further comprising at least a one-way fill valve coupled to the first and / or second compartment.

3. In claim 2, The at least one-way fill valve is configured to allow the first and / or second compartments to be filled with liquid while preventing liquid from leaking from the first and / or second compartments.

4. In claim 1, The pouch further comprises a first one-way fill valve coupled to the first compartment and a second one-way fill valve coupled to the second compartment.

5. In claim 4, The first one-way fill valve is configured to allow the first compartment to be filled with a liquid while preventing the liquid from escaping the first compartment, and the second one-way fill valve is configured to allow the second compartment to be filled with a liquid while preventing the liquid from escaping the second compartment.

6. In claim 1, The first and second coupling assemblies each include a frangible seal.

7. In any one of claims 1 to 6, The pouch, wherein the first coupling assembly is weaker than the second coupling assembly, such that the first coupling assembly can be opened without opening the second coupling assembly to communicate between the first chemical and the second chemical.

8. 1. A method of using a pouch having a first compartment containing a first chemical, a second compartment containing a second chemical, a third compartment containing a dry wipe, a first coupling assembly for selectively coupling the first compartment and the second compartment, and a second coupling assembly for selectively coupling the second compartment and the third compartment, the method comprising: The pouch has the first compartment, the second compartment, and the third compartment disposed side by side with each other, and further has a wall between the first compartment and the third compartment configured to hermetically seal the first compartment and the third compartment and prevent communication between the first compartment and the third compartment; maintaining the first coupling assembly in a closed configuration in which the first compartment is not in communication with the second compartment; maintaining the second coupling assembly in a closed configuration in which the second compartment is not in communication with the third compartment; breaking the first coupling assembly to place the first coupling assembly in an open configuration in which the first compartment is in communication with the second compartment and the first and second chemicals are mixed; and breaking the second coupling assembly to place the second coupling assembly in an open configuration in which the second compartment communicates with the third compartment and the wall communicates the first compartment with the third compartment only through the second compartment, leaving the dry wipe saturated with a mixture of the first and second chemicals.

Citation Information

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