Inactivation wipe kit, method of preparation and use thereof

Abstract

To provide a wipe kit which can be introduced into a controlled environment.SOLUTION: A hazardous drug deactivation wipe kit 100 includes a first pouch 102 having a one-way valve 208 coupled to one end thereof, a second pouch 104, and a third pouch 106. The first pouch 102 contains a wipe 209 saturated in a hypochlorite solution, the second pouch 104 contains a wipe saturated in a thiosulfate solution, and the third pouch 106 contains a wipe saturated in an isopropyl alcohol solution. The deactivation wipe kit may be used in a clean room to deactivate most hazardous drugs on a work surface.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Related Applications) This application is an international application of U.S. Patent Application No. 15 / 271,957, filed on September 21, 2016, which claims the benefit of U.S. Provisional Application No. 62 / 320,999, filed on April 11, 2016. These applications are hereby incorporated by reference in their entirety into the present disclosure.

[0002] (Field of the Invention) The present invention relates to wipe kits for use in deactivation, decontamination, disinfection or cleaning in clean room environments, as well as methods of making and using the same.

Background Art

[0003] A clean or controlled environment is a space designed, maintained and controlled to prevent contamination of products by particles and microorganisms. Clean environments include clean rooms and clean work spaces (such as fume hood-equipped work spaces), which are collectively referred to as clean rooms hereinafter. Clean rooms are most commonly designed for use in manufacturing facilities as well as medical research and processing facilities in the pharmaceutical, biotechnology, and healthcare industries, to name a few examples. Sterile clean room environments can be classified according to various classification schemes including the clean room standards of the International Organization for Standardization ("ISO"), with the highest level of sterilization being the ISO 1 clean room, and a normal atmospheric environment (non-sterile) being classified as ISO 9.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Certain chemical compositions used in cleanrooms include, for example, bactericidal disinfectants such as phenol, cleaners, quaternary ammonium compounds, and peracetic acid, as well as various spore-killing agents such as peracetic acid, bleaches, and hydrogen peroxide. Bactericidal and spore-killing agents are used to disinfect cleanroom surfaces within the cleanroom. In certain cleanroom environments, such as in the healthcare industry, surfaces may be exposed to certain hazardous substances. In such situations, chemicals are needed that can inactivate and decontaminate hazardous substances on work surfaces to reduce the occupational exposure risk to technicians and other workers in the cleanroom, as well as the risk to products and chemicals being produced within the cleanroom. Methods for inactivating, decontaminating, and disinfecting / cleaning surfaces exposed to hazardous substances are outlined in the US Pharmacopeial Convention (USP). <800> and USP <797> The requirements outlined therein must be met. Conventional methods of cleanroom sterilization are unsuitable for this purpose because they merely spread the agent around the affected surface rather than adequately inactivating (deactivating) the harmful substances. On the other hand, products that may inactivate harmful substances are not suitable for use in cleanrooms classified as ISO 5.

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

[0006] To sterilize compositions outside a cleanroom, concentrated compositions may be sterilized by irradiation or subjected to aseptic treatment. For final irradiation sterilization of a composition, the composition is placed in a container, double-bagged, and then placed in a lined carton. The entire carton is then sterilized by radiation. Procedures for final irradiation sterilization of compositions are described, for example, in U.S. Patent No. 6,123,900 granted to Vellutato, and the contents disclosed therein are referenced and incorporated into this application. However, some chemicals used in cleanrooms cannot be irradiated due to their chemical composition and structure. For example, certain chemicals used to inactivate harmful agents and decontaminate within a cleanroom cannot be irradiated. This presents problems in introducing such chemicals into a cleanroom environment and complicates the sterilization process. [Means for solving the problem]

[0007] This invention relates to an inactivation wipe kit that improves the inactivation of harmful agents from sterile surfaces in a cleanroom, decontamination, and disinfection / cleaning. The inactivation wipe kit of this invention can be irradiated outside the cleanroom environment and can be more efficiently transported and introduced into the cleanroom. [Brief explanation of the drawing]

[0008] The present invention and its many associated advantages will be obtained and further understood by referring to the following detailed description in consideration of the accompanying drawings.

[0009] [Figure 1] This is a front perspective view of an inactivation wipe kit according to one embodiment of the present invention.

[0010] [Figure 2] This is a front plan view of a first pouch of an inactivating wipe kit having a one-way valve, according to one embodiment of the present invention.

[0011] [Figure 3] Figures 3A to 3E are perspective views of the one-way valve shown in Figure 2.

[0012] [Figure 4] This is a flowchart outlining the steps for creating an inactivation wipe kit according to one embodiment of the present invention.

[0013] [Figure 5] This is a flowchart outlining the steps for using an inactivation wipe kit according to one embodiment of the present invention. [Modes for carrying out the invention]

[0014] Referring to Figure 1, an inactivation wipe kit 100 is shown. The term “wipe kit” is used, though often used herein, to refer to the inactivation wipe kit 100. In one embodiment, the wipe kit 100 includes three pouches 102, 104, and 106. Each of these pouches contains a wipe impregnated (soaked, saturated) with a different chemical used to inactivate (deactivate) and decontaminate hazardous substances in a cleanroom environment and to disinfect work surfaces (workbenches, preparation tables, preparation surfaces, compounding surfaces). When using the wipes, the technician shall take each wipe from pouches 102, 104, and 106 respectively and apply them in order to the contaminated work surface, namely, the wipe in pouch 102 shall be used first, the wipe in pouch 104 second, and the wipe in pouch 106 last. When used in this manner, the inactivation wipe kit 100 shall comply with the United States Pharmacopeia Agreement (USP) <800> and USP <797> As stipulated, most hazardous drugs are inactivated, decontaminated, and sterilized / cleaned from the work environment for compounding sterile preparations (sterile formulations), such as an ISO 5 cleanroom.

[0015] In one embodiment, the first pouch 102 contains a wipe impregnated with a 5.25% hypochlorite solution, for example, sodium hypochlorite (e.g., HYPO-CHLOR®, commercially available from Beltech Associates, Malvern, Pennsylvania). This composition is the primary active agent for inactivating hazardous drugs. It inactivates any potential activating drugs that may be present on the preparation (working) surface, and makes the surface safe and decontaminated for the next person handling it, complying with the USP regarding handling hazardous drugs in a medical facility. <800> In addition, USP regarding the preparation of sterile preparations in patient protection protocols. <797> Ensure that formulations are prepared in compliance with the following. The use of sodium hypochlorite is preferred, but any chemical known to inactivate harmful drugs may be used to impregnate the wipes of the first pouch 102, and such chemicals include, but are not limited to, potassium permanganate and alkaline potassium permanganate.

[0016] The second pouch 104 contains a wipe impregnated with a 2% thiosulfate solution, such as sodium thiosulfate (e.g., THIO-WIPE®, commercially available from Beltech Associates). In a preferred embodiment, the sodium thiosulfate is USP grade. This composition is used to remove hypochlorite solution residue from the treated work surface. The thiosulfate neutralizes the hypochlorite, which is a corrosive substance remaining on the surface, thereby maintaining the surface structure and preventing damage. It also serves to decontaminate the surface. While sodium thiosulfate is preferred, any chemical known to be able to remove and neutralize contamination from a work surface treated with hypochlorite can be used. Thus, the sodium thiosulfate solution cleans, decontaminates, and neutralizes the sodium hypochlorite solution and previously inactivated harmful drugs. This improves the overall lifespan of the equipment for sterile compounding and USP <797> and USP <800> It can be made to continue complying with it.

[0017] The third pouch 106 contains a wipe impregnated with 70% isopropyl alcohol (IPA) (e.g., ALCOH-WIPE®, commercially available from Beltech Associates) which acts as a disinfectant. In a preferred embodiment, the IPA is USP grade. This wipe further cleans and disinfects the treated surface and, for worker safety, returns the surface to its original state. 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 disinfectants such as phenol, quats, peroxyacetic acid (POAA), and H2O2. Thus, IPA further protects the surface by taking further measures against contaminants present on the surface for compounding or preparation. After the work surface has been deactivated, additional disinfection is required to maintain a critically controlled work environment for preparing sterile products.

[0018] The three chemicals used in pouches 102, 104, and 106 may all be formulated with water for injection (WFI) and may be filtered to 0.2 microns. Once the surface has been completely treated with all three wipes, the surface can return to its original composition (state).

[0019] Each of the wipes contained in pouches 102, 104, and 106 is preferably made of a nonwoven (non-woven fabric) material that is clean, has good absorbency, and has good surface coverage, and is designed to be difficult to peel off. The wipes (wiping materials, cleaning materials) should have excellent low peeling properties and must not easily detach fibers from the wipes to prevent contamination of the cleanroom work surface. In one embodiment, the wipes in the first pouch 102 are made of 100% polypropylene, and the wipes in the second pouch 104 and the 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 that will be placed in each of the pouches 102, 104, and 106. Each of these materials is a woven (cloth) wipe that is strong, has excellent low peeling properties, can be used in a controlled environment, and is compatible with the chemicals it is immersed in. In one embodiment, the wipe is approximately 9 inches x 12 inches in size and can treat a surface area of ​​approximately 6 square feet.

[0020] In one embodiment, the wipe for the first pouch 102 is 48-gauge polyester, 162XL-4019, having an ALOX coating bonded to 150 (6 mil) white polyethylene. This particular substrate can retain activated hypochlorite, but other suitable wipes may be used. Furthermore, the material of this wipe can minimize the degradation and instability associated with hypochlorite that occurs when exposed to organic materials. In one embodiment, one wipe is provided for each pouch 102, 104, and 106, but two or more wipes may be provided for any or all of the pouches 102, 104, and 106.

[0021] The pouches 102, 104, 106 themselves are designed to have flexible packaging structures corresponding to these wipes. The pouches 102, 104, 106 are preferably formed of a material that acts as a barrier against moisture, air and light, has excellent chemical resistance, and desirably can maintain their structural integrity during radiation irradiation, in a clean room, and even when ultimately stored on a shelf. In one embodiment, each of the pouches 102, 104, 106 is formed with a multilayer structure consisting 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, 106 may be Glenroy, Inc.'s ExpressWeb EFS174, which is attached hereto and incorporated herein by reference. When a multilayer structure is adopted, these materials can be hermetically and liquid-tightly sealed and have excellent chemical resistance (since the stability of the final product can be affected by light, oxygen and organic substances). They also serve to retain the active agent in each chemical and help extend the 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 of Figure 2. The notch 212 can be formed on the side of the pouches 102, 104, 106, so that a user can tear open the pouches 102, 104, 106 by pulling the side of the pouch at the location of the notch 212. Accordingly, in use, a technician can pull the pouch along the tear line to tear open the pouches 102, 104, 106 and access the impregnated wipes contained therein.

[0022] In order to introduce the inactivating wipe cloth kit 100 into a cleanroom, it (and its contents) must first be sterilized. In one embodiment, parts of the inactivating wipe kit 100 are irradiated to prevent contaminants from being introduced into the controlled environment. The second pouch 104 and the third pouch 106 contain chemicals, which may be final-stage radioactive sterilization by methods such as those described herein. Thus, the assembled pouches 104 and 106 may undergo known final-stage radioactive sterilization. However, the first pouch 102 contains a chemical that cannot be final-stage radioactive sterilized (i.e., sodium hypochlorite). Unlike the second pouch 104 and the third pouch 106, the first pouch 102 is configured so that the chemicals are added after the first pouch 102 has been sterilized.

[0023] As shown in Figure 2, the first pouch 102 is designed with a one-way valve 208 located at one end 210, and the pouch 102 contains wipes 209. This valve 208, as shown in more detail in Figures 3A-3E, allows fluid to pass in only one direction. Therefore, the first pouch 102, containing only dry wipes, may undergo final radiation sterilization along with the second pouch 104 and the third pouch 106 (each containing wipes and their respective chemicals). Subsequently, when pouches 102, 104, and 106 are transferred to a cleanroom, the first pouch 102 is aseptically filled with a sterilized hypochlorite solution via the one-way valve 208, impregnating the dry wipes contained within. The sterilized hypochlorite solution may be of any concentration as appropriately determined by those skilled in the art. For example, a 5.25% hypochlorite solution can be used. At this stage, the inactivation wipe kit 100 is fully ready for use in the cleanroom. The wipes for the kit can be of any conventional, known size, typically such as 3"×4", 4"×6", 9"×9", 9"×12", or 12"×12". The second and third pouches 104 and 106 house the wipes in a manner similar to that shown in Figure 2, except that all four sides of the second and third pouches 104 and 106 are completely sealed and do not contain valves 208 on any side.

[0024] The process of preparing (providing) the deactivated wipe kit 100 is outlined in the flowchart of Figure 4. Each of the pouches 102, 104, 106 may be prepared sequentially, or may be prepared simultaneously by different technicians. Accordingly, steps 400, 402, 404 may be performed sequentially or simultaneously. As described in more detail below, the chemicals and materials described above are used in each step.

[0025] In step 400, a dry wipe material is placed into the first pouch 102 and hermetically sealed to form a first sealed or enclosed container or pouch. In this step, no chemicals are placed into the first pouch 102. A wipe infiltrated with a first solution, for example a thiosulfate solution (e.g., THIO-WIPE(TM)), is placed into the second pouch 104 and hermetically sealed to form a second sealed or enclosed container or pouch (step 402). A wipe infiltrated with a second solution, for example 70% concentration IPA (e.g., ALCOH-WIPE(registered trademark)), is placed into the third pouch 106 and hermetically sealed to form a third sealed or enclosed container or pouch (step 404). At step 406, each of the pouches 102, 104, 106 is hermetically sealed so that the contents of each respective pouch are covered. In one embodiment, the hermetic sealing is a process that seals the pouches 102, 104, 106 in a liquid-tight and air-tight manner, such as heat sealing. Although the heat sealing of step 406 is shown as a separate step, it may be part of each filling process in steps 400, 402, 404.

[0026] In step 408, the first, second, and third sealed pouches 102, 104, and 106 are assembled (put together) for preparation for radiation sterilization, respectively. In step 410, the first, second, and third sealed pouches 102, 104, and 106 are assembled one by one and put together into a first container, such as a first plastic bag, and the first plastic bag is then sealed to form a first sealed pouch enclosure. In another example, the first sealed pouch enclosure may be put into a second container, such as a second plastic bag, and the second plastic bag is sealed to form a second 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 put into a plastic liner bag (e.g., a polyethylene bag), and the liner bag is closed and then placed in a box or other container. In step 412, when the liner is closed (tied or fastened with a zipper), the box containing it is closed, forming a sealed package. In step 414, the box and its contents may be subjected to final radiation sterilization using known techniques and equipment, and may be transported to a radiation device for sterilization, forming a sterilized and sealed container. Radiation sterilizes the container and its contents, i.e., plastic bags, wipes, pouches, and solutions.

[0027] The irradiated box (sterilized and sealed container) is then moved to a clean environment, and the sterilized and sealed pouch enclosure is removed from the plastic liner bag. 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 an inactivating chemical. In one embodiment, in step 418, the first sealed pouch 102 is aseptically filled with a sterile hypochlorite solution via a one-way valve 208 in a cleanroom. At this stage, once the first pouch 102 is filled with the solution, the dry wiping material inside the pouch 102 is impregnated with the solution, thereby preparing a pre-impregnated hypochlorite wiper. The valve 208 is designed to seal automatically, but other suitable valve designs may be provided.

[0028] When the valve 208 closes, the first sealed pouch 102 becomes the first sealed or packed pouch, ready for use. In other examples, the first sealed and packed pouch 102 may be further sealed in a first container such as a plastic bag, and further continuously sealed in a second container such as a plastic bag to form the first or second packed pouch enclosure. When the first sealed and packed pouch 102 (or the first / second packed pouch enclosure) is ready for use, the inactivation wipe kit 100 is formed by combining one of the irradiated second sealed pouches 104 with one of the irradiated third sealed pouches 106. In other examples, the inactivation wipe kit 100 may be hermetically heat-sealed in a first container (e.g., a polyethylene bag), and further continuously hermetically heat-sealed in a second container such as a plastic bag (e.g., a polyethylene bag). Multiple wipe kits 100 may be placed together in a carton with a plastic liner. The plastic liner can be closed (by tying it or by fastening it with a zipper (string)), and the box can be closed to form a final sealed package. The box can then be shipped for use by the customer.

[0029] Another process for creating the inactivation wipe kit 100 is also possible. Placing the dry, wiping material into the first pouch 102 (step 400) may be done before, during, or after placing the thiosulfate-soaked wipes into the second pouch 104 (step 402), and further, before, during, or after placing the IPA-soaked wipes into the third pouch 106 (step 404). Similarly, placing the thiosulfate-soaked wipes into the second pouch 104 (step 402) and the IPA-soaked wipes into the third pouch 106 (step 404) can be done 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 that they are packaged together in the same box. On the other hand, the irradiated second and third pouches may be packaged together in a separate box from the first final pouch.

[0030] Furthermore, other suitable techniques may be used to sterilize pouches 102, 104, and 106 with radiation. For example, multiple pouches 102, 104, and / or 106 may be heat-sealed in the same or different individual first (and optionally second) plastic bags. In one embodiment, each sealed pouch 102, 104, and 106 may be individually single / double bagged (i.e., heat-sealed in a first plastic bag (and optionally a further second plastic bag) to provide first and second enclosures sealed for the first, second, and third sealed pouches, respectively), and then sterilized in carton liners and boxes. In another embodiment, a plurality of first sealed pouches 102 are placed in a first bag and heat-sealed together to form a first enclosure; a plurality of second sealed pouches 104 are placed in a second bag and heat-sealed to form a second enclosure; a plurality of third sealed pouches 106 are heat-sealed in a third bag to form a third enclosure; and furthermore, the first, second, and third enclosures are placed in a liner and a box and irradiated simultaneously.

[0031] Furthermore, multiple first sealed pouches 102 may be individually bagged in single or double layers and placed in a first box, multiple second sealed pouches 104 may be individually bagged in single or double layers and placed in a second box, and furthermore, multiple third pouches 106 may be individually bagged in single or double layers and placed in a third box. Alternatively, multiple first sealed pouch enclosures may be placed in one first box for radiation irradiation, and multiple second and third pouch enclosures may be placed together in one second box for radiation irradiation. Furthermore, the first and second containers may be any suitable containers such as pouches, and the first, second and third pouches 102, 104, and 106 may be any suitable containers.

[0032] Thus, the end user can receive a single box containing multiple kits, each kit having first, second, and third sterile and sealed pouches. The method of use of the inactivation wipe kit 100 is outlined in Figure 5. When the box arrives at the customer's location, the box and its liner are opened (e.g., in a cleanroom or temporary storage area (staging area)). One kit 100 may be taken out of the box for use and brought into the cleanroom. The heat-sealed bag is opened and pouches 102, 104, and 106 are removed. As shown in step 500, the first pouch 102 is opened (e.g., by tearing along the perforation line 212) and the hypochlorite-impregnated wipes are removed. Then, in step 502, a contaminated work surface (preparation surface, preparation table) is wiped with the wipes to inactivate one or more harmful agents. Next, in step 504, the second pouch 104 is opened and a wipe impregnated with thiosulfate is removed. Next, in step 506, the work surface that has just been treated with the hypochlorite-impregnated wipe is wiped with a buffing agent to remove surface contamination and any hypochlorite residue that may still be present on the surface. Next, in step 508, the third pouch 106 is opened and a wipe impregnated with IPA is removed. Finally, in step 510, the wipe is used to wipe the work surface, disinfecting and cleaning it so that it can be used safely by technicians or workers. If each wipe is used consecutively on the surface, all harmful substances present are inactivated, contaminated, the surface is disinfected, and it can be used safely by technicians.

[0033] As described, it is clear that the present invention can take several different forms within its scope. The first, second, and third pouches can be individually bagged in single / double pouches (i.e., the first pouch and then the second pouch can be sealed). Alternatively, the second and third pouches can be bagged together in single / double pouches for irradiation and delivery to the end user, and may be housed together in one box with the double-bagged first filled pouch enclosure, or they may be boxed separately from the single / double-bagged first filled pouch enclosure. Further 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 sterile and sealed pouches, and a second box containing a plurality of second and third sterile and sealed pouches. Furthermore, although the present invention describes the use of three pouches, each containing a different solution, two or four or more other suitable numbers of pouches and solutions may be used.

[0034] While the present invention is described in relation to its particular forms and embodiments, 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, within the scope of the invention as defined in all appended claims, equivalent elements may be substituted with those specifically illustrated and described, certain features may be used independently of others, and in some cases, certain positions of elements may be reversed or interposed.

[0035] Disclosed above is an inactivation wipe kit (100) for hazardous drugs, which is used to inactivate hazardous drugs on a work surface in a controlled environment. The kit comprises a first pouch (102) with a one-way valve (208) coupled to one end, containing a first pouch containing a wipe (209) impregnated in a hypochlorite solution, a second pouch (104) containing a wipe impregnated in a thiosulfate solution, and a third pouch (106) containing a wipe impregnated in an isopropyl alcohol solution. The hypochlorite solution may be a 5.25% sodium hypochlorite solution. The thiosulfate solution may be a 2% sodium thiosulfate solution. The isopropyl alcohol solution may be a 70% isopropyl alcohol solution. The wipe in the first pouch may be made of 100% polypropylene. The wipes in the second pouch and the third pouch may be made of 100% polyester. Each of the first pouch, the second pouch, and the third pouch may be formed of a multilayer structure consisting of coated polyester, low-density polyethylene, aluminum foil, hydroxypropyl cellulose, linear low-density polyethylene, or a combination thereof. Each of the first pouch, the second pouch, and the third pouch may have a cut line near one end. The one-way valve may be configured to allow the first pouch to be filled with the hypochlorite solution after the wipe has already been sealed in the first pouch.

[0036] The above discloses a method for preparing an inactivation wipe kit. This method comprises the following steps: (a) A drying wipe is placed inside a first pouch (102) to which a one-way valve (208) is attached at one end, (b) Place a wipe soaked in thiosulfate into the second pouch (104), and (c) Place a wipe soaked in isopropyl alcohol into the third pouch (106). (d) sealing the first pouch (102), the second pouch (104), and the third pouch (106) to form the first sealed pouch, the second sealed pouch, and the third sealed pouch, respectively. (e) Placing the first sealed pouch, the second sealed pouch, and the third sealed pouch inside a plastic bag, and sealing the plastic bag to form a sealed pouch enclosure, (f) Placing the sealed pouch enclosure inside a container, and sterilizing the container and its contents with radiation to form a sterilized sealed container, (g) Transferring the sterilized sealed container to a controlled environment, and removing the first sealed pouch, the second sealed pouch, and the third sealed pouch from the sealed pouch enclosure, (h) Fill the first sealed pouch with a sterile hypochlorite solution in a sterile manner via the one-way valve, and impregnate the dry wipe with the hypochlorite solution.

[0037] In step (d) and / or step (e), the first pouch, the second pouch, the third pouch, and / or the plastic bag may be sealed by heat fusion. Steps (a)-(c) may be performed sequentially or in parallel. Step (e) may further include placing the first sealed pouch, the second sealed pouch, and the third sealed pouch into the first plastic bag, sealing the first plastic bag to form the first sealed pouch enclosure, and placing the first sealed pouch enclosure into the second plastic bag to form the second sealed pouch enclosure. Step (h) may further include forming the first sealed filled pouch, placing the first sealed filled pouch, the second sealed pouch, and the third sealed pouch into the final plastic bag, and sealing the final plastic bag to form the final sealed pouch enclosure. This method may further include the step of placing the final sealed pouch enclosure into a liner and container. The radiation sterilization step may sterilize the first pouch, the second pouch, the third pouch, the dry wipes, the thiosulfate-soaked wipes, the isopropyl alcohol-soaked wipes, the plastic bag and container.

[0038] The above discloses a method for using the inactivation wipe kit described above. This method includes the following steps: (a) Remove the wipe from the first pouch and apply the wipe to a work surface contaminated with at least one harmful chemical, (b) Taking the wipe out of the second pouch and applying the wipe to the work surface, (c) removing the wipe from the third pouch and applying the wipe to the work surface, Step (a) is to inactivate the harmful agent, step (b) is to remove contamination from the work surface, and step (c) is to disinfect and clean the work surface. Steps (a)-(c) may be performed in order. The wipes may be removed from the first pouch, the second pouch, and the third pouch by tearing along the respective cut lines of the first pouch, the second pouch, and the third pouch, respectively.

[0039] The above discloses an inactivation wipe kit (100) comprising a one-way filling valve (208) coupled to one end of a first pouch (102) having a first pouch containing a wipe (209) impregnated with a first solution, and a second pouch (104) containing a wipe impregnated with a second solution. The kit may further have a third pouch (106) containing a wipe impregnated with a third solution. The first solution may contain sterile hypochlorite, the second solution may contain thiosulfate, and the third solution may contain isopropyl alcohol. The kit may be configured for use in a controlled environment to inactivate harmful drugs on a work surface. The one-way filling valve may be configured to allow the first solution to be filled into the first pouch and to prevent leakage of the first solution from the first pouch.

[0040] The above discloses a method for preparing an inactivating wipe kit, which includes the following steps: (a) placing a dry first wipe (209) into a first pouch (102) to which a one-way filling valve (208) is coupled at one end, and closing the first pouch to form a first sealed pouch; (b) Place the second wipe soaked in the second solution into the second pouch (104), close the second pouch to form a second sealed pouch, (c) Radiation sterilization of the first sealed pouch to form the first sterilized sealed pouch, (d) Radiation sterilization of the second sealed pouch to form a second sterilized sealed pouch, (e) Filling the first sterile and sealed pouch with the first solution via the one-way filling valve (208) and impregnating the dry first wipe (209) with the first solution.

[0041] Step (e) is to form a first sterile, filled, and sealed pouch, and the method may further include the step of placing the first sterile, filled, and sealed pouch into a first bag and sealing the first bag to form a first sterile, filled, and sealed pouch enclosure. The method may further include the step of placing the second sealed pouch into a second bag and sealing the second bag to form a second sealed pouch enclosure.

Claims

1. The first flexible pouch comprises at least one first wipe soaked in a first solution, the first solution configured to inactivate harmful drugs; the second flexible pouch comprises at least one second wipe soaked in a second solution, the second solution configured to wash, decontaminate, and neutralize the first solution; and the third flexible pouch comprises at least one third wipe soaked in a third solution, the third solution configured to be a disinfectant. The first flexible pouch comprises at least one first wipe soaked in a third solution, the third solution configured to be a disinfectant. The first flexible pouch comprises at least one first wipe soaked in a first flexible pouch comprising at least one first wipe soaked in a second flexible pouch comprising at least one first wipe soaked in a first second flexible pouch comprising at least one first wipe soaked in a second flexible pouch comprising at least one first wipe soaked in a second flexible pouch comprising at least one first wipe soaked in a second flexible pouch comprising at least one first wipe soaked in a second flexible pouch comprising at least one first wipe soaked in a first flexible pouch comprising at least one first wipe soaked in a first flexible pouch comprising at least one first wipe soaked in a second flexible pouch comprising at least one second wipe soaked in at least one second flexible pouch comprising at least one second wipe soaked in at least one second flexible pouch comprising at A cleanroom wipe kit comprising the first, second, and third flexible pouches, each sealed and having at least one of a notch and / or a cut line near one end, wherein the first, second, and third solutions are different chemicals from each other, the first solution is a non-radio-sterilizable solution, and each of the first, second, and third flexible pouches is configured for radiation sterilization, and assembled as a kit by housing the first flexible pouch filled with the first solution after radiation sterilization, and the second and third flexible pouches filled with the second and third solutions respectively and then radiation sterilized, in a sterilized plastic bag for transport into a cleanroom.

2. A wipe kit for a cleanroom, according to claim 1, wherein the first flexible pouch includes a one-way filling valve configured to allow the first solution to be filled into the first flexible pouch while preventing the first solution from leaking out of the first flexible pouch.

3. A wipe kit for a cleanroom, according to claim 2, wherein the one-way filling valve is configured to allow the first flexible pouch to be filled with the first solution after the first wipe has already been sealed in the first flexible pouch.

4. A wipe kit for a cleanroom, according to any one of claims 1 to 3, wherein the first solution is a hypochlorite solution, the second solution is a thiosulfate solution, and the third solution is an isopropyl alcohol solution.

5. A wipe kit for a cleanroom, wherein the hypochlorite solution is a 5.25% sodium hypochlorite solution, according to claim 4.

6. A wipe kit for a cleanroom, wherein the thiosulfate solution is a 2% sodium thiosulfate solution, according to claim 4.

7. A wipe kit for a cleanroom, wherein the isopropyl alcohol solution is a 70% isopropyl alcohol solution, according to claim 4.

8. A wipe kit for a cleanroom, according to any one of claims 1 to 3, wherein the first wipe of the first flexible pouch is made of polypropylene, and the second wipe of the second flexible pouch and the third wipe of the third flexible pouch are made of polyester.

9. A wipe kit for a cleanroom, according to any one of claims 1 to 3, wherein each of the first, second, and third flexible pouches includes an indicator to show that the first, second, and third wipes should be used in sequence.

10. A wipe kit for a cleanroom, according to claim 9, wherein the marking on the first flexible pouch is number 1, the marking on the second flexible pouch is number 2, and the marking on the third flexible pouch is number 3.

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