Patent Description:
The invention relates to a wipe pouch used for deactivation, decontamination, and disinfection or cleaning in a clean room environment and a method of preparing and using the same.

A clean environment or controlled environment is a space designed, maintained, and controlled to prevent particle and microbiological contamination of products. Clean environments include clean rooms and clean workspaces (such as hooded workspaces), which are collectively referred to here as a clean room. Clean rooms are most commonly designed for use in manufacturing facilities and medical research and treatment facilities in the pharmaceutical, biotechnology, and healthcare industries, to name a few. Sterile clean room environments may be classified under a variety of classification schemes, including the International Organization of Standardization ("ISO") Cleanroom Standards, whereby the highest level of sterilization is an ISO <NUM> clean room and a normal ambient air environment (no sterilization) is classified as ISO <NUM>.

Certain chemical compositions are used inside clean rooms including, for instance, germicidal disinfectants such as phenols, cleaners, quaternary ammonium, peracetic acid, as well as various sporicides, such as peracetic acid, bleach, and hydrogen peroxide. The disinfectants and sporicides are used in clean rooms to disinfect clean room surfaces. In certain clean room environments, such as those in the healthcare industry, surfaces can become exposed to certain hazardous drugs. In those situations, chemicals are needed that can deactivate and decontaminate hazardous drugs on work surfaces to reduce the risk of occupational exposure to technicians and other workers in the clean room, as well as to products or chemicals being prepared in the clean room. The methods of deactivating, decontaminating and disinfecting/cleaning surfaces exposed to hazardous drugs must meet the requirements set forth in USP <<NUM>> and USP <<NUM>> set forth by the U. Pharmacopeial Convention (USP). Conventional methods of clean room sterilization are lacking for this purpose because they do not adequately deactivate the hazardous drugs, but instead simply spread the drug around on the affected surface. On the other hand, products that may be capable of deactivating hazardous drugs are not suitable for use inside of a classified ISO <NUM> clean room.

Further, the chemical compositions, which are not naturally sterile, need to be sterilized before being able to enter the clean room to avoid risk of contamination. Such compositions can be sterilized by filtration inside of the clean room or can be sterilized before entering the clean room.

To sterilize the compositions outside the clean room, the concentrated composition is either terminally sterilized by irradiation or aseptically processed. To terminally irradiation sterilize the composition, the composition is placed in a container, double bagged, and placed in a lined carton. The entire carton is then terminally sterilized by irradiation. A procedure for terminally irradiation sterilizing a composition is described, for instance, in <CIT>. Some chemicals used in a clean room, however, cannot be irradiated because of their chemical makeup and structure. For example, certain chemicals used to deactivate and decontaminate hazardous drugs in clean rooms cannot be irradiated. This creates problems for introducing such chemicals into a clean room environment and complicates the sterilization process.

<CIT> discloses a cleaning solution kit which includes a liquid that is disposed within a first compartment and that is isolated from a cleaning solid disposed in a second compartment by a first openable barrier. When the first openable barrier is opened, the liquid and cleaning solid are exposed to one another, forming the cleaning solution. There is further disclosed a cleaning kit which includes the first and second compartments of the cleaning solution kit and also includes wipes. The wipes are disposed within a third compartment and are isolated from the cleaning solid and the liquid by a second openable barrier and the first openable barrier. When wipes are needed to clean an area, after the cleaning solution is formed by opening the first openable barrier, the second barrier is opened and the cleaning solution wets the wipes. The wipes are then ready for cleaning surfaces within an area.

<CIT> discloses a hazardous drug deactivation wipe kit which includes a first pouch having a one-way valve coupled to an end thereof, a second pouch, and a third pouch. The first pouch contains a wipe saturated in a hypochlorite solution, the second pouch contains a wipe saturated in thiosulfate solution, and the third pouch contains a wipe saturated in isopropyl alcohol solution. The deactivation wipe kit may be used in a clean room to deactivate most hazardous drugs on a work surface.

Accordingly, the invention is directed to a deactivation wipe pouch that improves deactivation, decontamination, and disinfection/cleaning of hazardous drugs from sterile surfaces in a clean room. The deactivation wipe pouch of the invention is also able to be irradiated outside of the clean room environment for more efficient transfer and introduction into a clean room.

It is one aspect of the invention to provide a wipe pouch according to independent claim <NUM> and a method of using a pouch according to independent claim <NUM>.

A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:.

It is to be noted that <FIG> and <FIG>do not represent embodiments according to the invention, but serve an illustrative purpose only. Detailed Description.

Referring now to <FIG>, a deactivation wipe kit <NUM> is illustrated. As used more fully herein, the term "wipe kit" is used to refer to the deactivation wipe kit <NUM>. The wipe kit <NUM> includes three pouches <NUM>, <NUM>, <NUM>. Each of these pouches contains a wipe that is saturated in a different chemical used to deactivate and decontaminate hazardous drugs in a clean room environment and disinfect the work surface. In use, the technician applies each wipe from each of the pouches <NUM>, <NUM>, <NUM> in sequence to a contaminated work surface, such that the wipe in the first pouch <NUM> is used first, the wipe in the second pouch <NUM> is used second, and the wipe in the third pouch <NUM> is used last. When used in this way, the deactivation wipe kit <NUM> deactivates, decontaminates, and disinfects/cleans most hazardous drugs from work environments for compounding sterile preparations, such as an ISO <NUM> clean room, as cited by USP <<NUM>> and USP <<NUM>> set forth by the U. Pharmacopeial Convention (USP).

The first pouch <NUM> contains a wipe that is saturated in a <NUM>% hypochlorite solution, such as sodium hypochlorite (e.g., HYPO-CHLOR® available commercially from Veltek Associates, Inc. of Malvern, PA). This composition is the primary agent that deactivates the hazardous drug(s). It deactivates potentially active drugs that may be present on a compounding surface, and renders the surface safe and decontaminated for future handlers and ensures that the compounding preparations are following USP <<NUM>> compounding sterile preparations for patient protection protocol along with USP <<NUM>> compliance for hazardous drugs (handling in healthcare settings). While the use of sodium hypochlorite is preferred, any chemical known to deactivate hazardous drugs may be used to saturate the wipe in the first pouch <NUM>, including, but not limited to, potassium permanganate and alkaline potassium permanganate.

The second pouch <NUM> contains a wipe that is saturated in <NUM>% thiosulfate, such as sodium thiosulfate (e.g., THIO-WIPE™ available commercially from Veltek Associates, Inc). The thiosultate is USP Grade. This composition is used in order to remove the hypochlorite solution residue from the treated work surface. The thiosulfate renders the hypochlorite, which is a corrosive material, neutral on the surface so as to maintain the surface's structure and integrity. It also functions to decontaminate the work surface. While sodium thiosulfate is preferred, any chemical known to decontaminate a work surface that has been treated with hypochlorite, and which can neutralize the same, may be used. Thus, the sodium thiosulfate solution cleans, decontaminates, and neutralizes the sodium hypochlorite solution and previously deactivated hazardous drugs. It improves the overall longevity of the sterile compounding equipment and stays USP <<NUM>> and USP <<NUM>> compliant.

The third pouch <NUM> contains a wipe that is saturated in <NUM>% isopropyl alcohol (IPA) (e.g., ALCOH-WIPE® available commercially from Veltek Associates, Inc. ), which functions as a disinfectant. The IPA is USP Grade. This wipe further cleans and disinfects the treated surface and returns the surface back to its original condition for worker safety. While IPA is preferred, any chemical known to clean and disinfect a work surface may be used, including, but not limited to, sterile water or known germicidal agents such as phenols, quats, peroxyacetic acid (POAA) and H<NUM>O<NUM>. Thus, the IPA provides an additional measure against contaminates present on the compounding surfaces for added protection. After deactivation of the work surface, additional disinfection is needed to maintain a critical, controlled, work environment for compounding sterile products.

All three chemicals used in each of the pouches <NUM>, <NUM>, <NUM> may be formulated with Water for Injection (WFI) and filtered at <NUM> microns. Once a surface is fully treated by all three wipes, the surface can return to its natural composition.

Each of the wipes contained in pouches <NUM>, <NUM>, <NUM> is preferably formed of a nonwoven, non-shedding material that is designed to be clean, have good absorption properties, and provide good surface coverage. The wipe should have good non-shedding properties, as fibers from the wipe should not be easily detached from the wipe so as to avoid contaminating the clean room work surface. The wipe of the first pouch <NUM> is formed of <NUM>% polypropylene, while the wipes in the second pouch <NUM> and third pouch <NUM> are formed of <NUM>% polyester. The material of each wipe is chosen for its compatibility with the particular chemical present in each of the pouches <NUM>, <NUM>, <NUM>. Each of these materials produces a fabric-like wipe that is strong, has good non-shedding particulate performance, and is compatible with the chemical in which it is saturated as well as use in a controlled environment. The edwipe is about <NUM> × <NUM> (<NUM>" × <NUM>") in size such that it can treat a surface area of approximately <NUM> square meter (<NUM> square feet).

The wipe for the first pouch <NUM> is a 162XL-<NUM>, <NUM> gauge polyester with an ALOX coating bonded to <NUM> (<NUM> mil) white polytheylene. This particular substrate retains the active hypochlorite, though other suitable wipes can be provided. Further, this wipe material minimizes the degradation and instability associated with hypochlorite caused by exposure to organic material. A single wipe is provided in each pouch <NUM>, <NUM>, <NUM>; however more than one wipe can be provided in any or all of the pouches <NUM>, <NUM>, <NUM>.

The pouches <NUM>, <NUM>, <NUM> themselves are designed as flexible packaging structures for the wipes. The pouches <NUM>, <NUM>, <NUM> are preferably formed of a material that provides a barrier to moisture, air and light and has good chemical resistance so as to maintain its structural integrity during irradiation and when ultimately shelved in the clean room. Each pouch <NUM>, <NUM>, <NUM> is formed of a multi-layered structure comprised of layers of coated polyester, low density polyethylene, aluminum foil, hydroxypropylcellulose, and/or linear low density polyethylene. For example, the pouches <NUM>, <NUM>, <NUM> can be ExpressWeb EFS174, by by Glenroy Inc. When prepared into a multi-layered structure, these materials provide an air-tight and liquid-tight seal and are highly chemically resistant (since stability of the finished product can be affected by light, oxygen and organic matter). They also help to maintain the active agents in each of the chemicals so as to prolong their shelf life. Each of the pouches <NUM>, <NUM>, <NUM> preferably includes a notch or perforation <NUM>, such as shown in <FIG> in the first pouch <NUM>. The notch <NUM> can be formed in the side of the pouch <NUM>, <NUM>, <NUM>, so that the user can tear open the pouch <NUM>, <NUM>, <NUM> by pulling on the side of the pouch at the notch <NUM>. Thus in use, the technician pulls the pouch along the perforation in order to tear the pouch <NUM>, <NUM>, <NUM> open to access the saturated wipe contained therein.

In order to introduce the deactivation wipe kit <NUM> into the clean room, it (and its contents) must first be sterilized. Part of the deactivation wipe kit <NUM> is irradiated to avoid introducing contaminants into the environment. The second pouch <NUM> and third pouch <NUM> contain chemicals that may be terminally irradiation sterilized, such as by the methods described herein. Thus, assembled pouches <NUM>, <NUM> may undergo known terminally irradiation sterilization. The first pouch <NUM>, however, contains a chemical (i.e., sodium hypochlorite) that cannot be terminally irradiation sterilized. As such, the first pouch <NUM> is configured differently than the second pouch <NUM> and third pouch <NUM> such that the chemical can be added after the first pouch <NUM> has been sterilized.

As set forth in <FIG>, the first pouch <NUM> is designed with a one-way valve <NUM> positioned at an end <NUM> thereof, and the pouch <NUM> contains a wipe <NUM>. This valve <NUM>, which is more fully illustrated in <FIG>, only allows fluids to be transferred through it in one direction. As such, the first pouch <NUM>, containing only a dry wipe, may be terminally irradiation sterilized, together with the second pouch <NUM> and third pouch <NUM> (each of which contain the wipe and the respective chemical). Then, when the pouches <NUM>, <NUM>, <NUM> are transferred to the clean room, the first pouch <NUM> may be aseptically filled with the sterilized hypochlorite solution via the one-way valve <NUM> to saturate the dry wipe contained therein. The sterilized hypochlorite solution may be of any concentration determined suitable to one or ordinary skill in the art. For example, a hypochlorite concentration of <NUM>% is used. At this point, the deactivation wipe kit <NUM> is fully ready for use in a clean room. The wipes contemplated for the kit may be of any conventional size known in the art, exemplarily <NUM> × <NUM>, <NUM> × <NUM>, <NUM> × <NUM>, <NUM> × <NUM>, <NUM> × <NUM> (<NUM>" × <NUM>", <NUM>" × <NUM>", <NUM>" × <NUM>", <NUM>" × <NUM>", <NUM>" × <NUM>").

A process of preparing the deactivation wipe kit <NUM> is outlined in the flow chart of <FIG>. Each pouch <NUM>, <NUM>, <NUM> may be prepared in sequence or simultaneously by different technicians. Thus, Steps <NUM>, <NUM>, <NUM> can be performed sequentially or at the same time. As set forth more fully below, each of the steps utilizes the chemicals and materials described above.

In Step <NUM>, a dry, wipe material is placed in the first pouch <NUM> and hermetically sealed to form a first closed or sealed container or pouch. At this step, there are no chemicals present in the first pouch <NUM>. A wipe saturated with a first solution, such as for example thiosulfate solution (e.g., THIO-WIPE™), is placed in the second pouch <NUM> and hermetically sealed to form a second closed or sealed container or pouch, Step <NUM>. A wipe saturated with a second solution, such as for example <NUM>% IPA (by concentration) (e.g., ALCOH-WIPE®), is placed in the third pouch <NUM> and hermetically sealed to form a third closed or sealed container or pouch, Step <NUM>. Each of the pouches <NUM>, <NUM>, <NUM> is hermetically sealed, Step <NUM>, to enclose the contents of each pouch. The hermetic seal is a liquid and air tight seal of the pouches <NUM>, <NUM>, <NUM>, such as for example a heat seal. Though the heat sealing, Step <NUM>, is shown as a separate step, it can be part of each of the filling processes of Steps <NUM>, <NUM>, <NUM>.

Each of the first, second and third sealed pouches <NUM>, <NUM>, <NUM> are assembled in preparation for irradiation sterilization, Step <NUM>. One of each of the first, second, and third sealed pouches <NUM>, <NUM>, <NUM> are assembled together and placed in a first container such as a first plastic bag and the first plastic bag is then hermetically sealed to form a first closed or sealed pouch enclosure, Step <NUM>. Optionally, the first sealed pouch enclosure can be placed in a second container such as a second plastic bag and the second plastic bag is then hermetically sealed to form a second closed or sealed pouch enclosure. The first and second plastic bags are a polyethylene bag that is heat sealed. The second (or first) sealed pouch enclosure is then placed into a plastic liner bag (e.g., a polyethylene bag) which is closed and placed into a box or other container. The liner is then closed (such as by being knotted or by a fastener (tie)) and the box is closed to form a closed package, Step <NUM>. The box and the enclosed contents are then terminally irradiation sterilized using known techniques and equipment, Step <NUM>, and can be shipped to an irradiator for sterilization, to form a sterilized closed container. The irradiation sterilizes the container and its contents, including the plastic bags, wipes, pouches, solutions.

The irradiated boxes (sterilized closed containers) are then transferred to a clean environment and the sterilized closed pouch enclosure is removed from the plastic liner bag. The sterilized first, second and third sealed pouches are then removed from the inner-most sealed plastic bag, Step <NUM>. At this point, the second sealed pouch <NUM> and the third sealed pouch <NUM> are ready for use. However, the first sealed pouch <NUM> must be filled with the deactivation chemical. The first sealed pouch <NUM> is aseptically filled with a sterile hypochlorite solution via the one-way valve <NUM> inside the clean room, Step <NUM>. At this step, when the first pouch <NUM> is filled with the solution, the solution is allowed to saturate the dry wipe in the pouch <NUM>, thereby preparing a saturated, hypochlorite wipe. The valve <NUM> may close automatically by virtue of its design, though other suitable valve designs can be provided.

Once the valve <NUM> is closed, the first sealed pouch <NUM> forms a first closed or sealed filled pouch that is then ready for use as well. Optionally, the first sealed filled pouch <NUM> can be successively hermetically sealed in a first container and optionally then a second container, such as plastic bags to form a first (and second) first filled pouch enclosure. Once the first sealed filled pouch <NUM> (or first / second filled pouch enclosure) is ready for use, it is matched with one of the irradiated second sealed pouch <NUM> and one of the irradiated third sealed pouch <NUM>, to form the deactivation wipe kit <NUM>. Optionally, the deactivation wipe kits <NUM> can be successively hermetically heat sealed in a first container (e.g., a polyethylene bag) and optionally then a second container (e.g., a polyethylene bag), such as plastic bags. Multiple wipe kits <NUM> are then placed together into a carton having a plastic liner. The plastic liner can be closed (such as by being knotted or by a fastener (tie)) and the box is closed to form the final closed package. The box can then be shipped to the customer for use.

Alternate processes of preparing the deactivation wipe kit <NUM> may also be performed. The drying, wiping, and placement of material in the first pouch <NUM> (Step <NUM>) may be performed before, during, or after the placement of the thiosulfate-saturated wipe in the second pouch <NUM> (Step <NUM>), and before, during or after the IPA-saturated wipe is placed in the third pouch <NUM> (Step <NUM>). Similarly, the placement of the thiosulfate-saturated wipe in the second pouch <NUM> (Step <NUM>) and the placement of the IPA-saturated wipe in the third pouch <NUM> (Step <NUM>) may occur in any order relative to the preparation of the other pouches, as long as all three pouches <NUM>, <NUM>, and <NUM> can be prepared prior to the step of heat sealing, if packaged together in a same box. However, the irradiated second and third pouches can be packaged together in a box separate from the first final pouch.

In addition, it will further be appreciated that other suitable techniques can be utilized to irradiation sterilize the pouches <NUM>, <NUM>, <NUM>. For instance, the multiple pouches <NUM>, <NUM>, and/or <NUM> can be heat sealed in the same or different individual first (and optionally second) plastic bags. Each closed pouch <NUM>, <NUM>, <NUM> can be individually single / double bagged (i.e., heat sealed in a first plastic bag (and optionally a successive second plastic bag) to form respective first and second sealed enclosures for the first, second and third closed pouches), then placed in a carton liner and a box and sterilized. Multiple first closed pouches <NUM> can be heat sealed together in a first bag to form a first enclosure, multiple second closed pouches <NUM> can be heat sealed in a second bag to form a second enclosure, and multiple third closed pouches <NUM> can be heat sealed in a third bag to form a third enclosure; and the first, second and third enclosures can be placed in a liner and box and simultaneously irradiated.

Still further, multiple first closed pouches <NUM> can individually be single/double bagged and placed into a first box; multiple second closed pouches <NUM> can individually be single/double bagged and placed into a second box; and multiple third pouches <NUM> can individually be single/double bagged and placed into a third box. Or, multiple first sealed pouch enclosures can be placed in a first box for irradiation, and multiple second and third pouch enclosures can be placed together in a second box for irradiation. In addition, the first and second containers can be any suitable containers such as pouches, and the first, second and third pouches <NUM>, <NUM>, <NUM> can be any suitable container.

Thus, an end user can receive a single box having multiple kits, each kit having a first, second and third sterilized closed pouch. A method of using the deactivation wipe kit <NUM> is outlined in <FIG>. Once the box arrives at the customer, the box and box liner are opened (e.g., in a clean room or staging area). A kit <NUM> can then be removed from the box for use, and brought into the clean room. The heat-sealed bag is opened and the pouches <NUM>, <NUM>, <NUM> are removed. As set forth in Step <NUM>, the first pouch <NUM> is opened (e.g., by tearing the perforation <NUM>) and the hypochlorite-saturated wipe is removed. The wipe is then applied to the contaminated work surface in order to deactivate the hazardous drug(s), Step <NUM>. Next, the second pouch <NUM> is opened and the thiosulfate-saturated wipe is removed, Step <NUM>. The wipe is then applied to the work surface that has just be treated with the hypochlorite-saturated wipe, Step <NUM>, in order to decontaminate the surface and remove any hypochlorite residue that may still be present on the surface. The third pouch <NUM> is then opened and the IPA-saturated wipe is removed, Step <NUM>. Lastly, the wipe is applied to the work surface in order to disinfect and clean the surface to render it safe for use by a technician or worker, Step <NUM>. Once each wipe is used consecutively on the surface, any hazardous drugs that are present are deactivated and decontaminated and the surface is disinfected and safe for use by the technician.

Thus, multiple variations for a pouch are apparent. The first, second and third pouches can be individually single / double-bagged (i.e., hermetically sealed in a first pouch and successive second pouch). Or the second and third pouches can be single / double-bagged together for irradiation and delivery to the end user; and either matched in a box with a double-bagged first filled pouch enclosure or boxed separately from the single / double-bagged first filled pouch enclosure. Still other variations are possible. For instance, the end user can receive a first box with the first sterilized closed pouches, and a second box with the second and third sterilized closed pouches. In addition, although the invention is described for use with three pouches each having a different solution, other suitable number of pouches and solutions can be provided, such as two or four or more.

For example, a further illustrative pouch is shown in <FIG>, <FIG>. Here, an alternative for the first pouch <NUM> is shown. The pouch <NUM> has two polyethylene layers <NUM>, <NUM> that are heat sealed at the edges (either directly to one another, <FIG>, or with a side wall therebetween, <FIG>) to define an interior space <NUM> therebetween. The pouch is substantially rectangular in shape with two longitudinal sides and two transverse sides that are substantially orthogonal to the longitudinal sides. A transverse coupling assembly, such as a frangible seal <NUM>, is formed in the center to define a first compartment <NUM> and a second compartment <NUM>. The first compartment <NUM> has a first layer 270a, second layer 272a and an interior space 274a therebetween, and the second compartment <NUM> has a first layer 270a, second layer 272a, and an interior space 274b therebetween. The frangible seal <NUM> is substantially parallel to the transverse sides and extends the entire width of the pouch <NUM>. The first and second compartments <NUM>, <NUM> are completely liquid tight so that liquid cannot pass from the first compartment <NUM> to the second compartment <NUM>, or vice versa.

In operation, the pouch <NUM> is formed by heat sealing the layers <NUM>, <NUM> along their two longitudinal sides (either directly to one another, <FIG>, or with a side wall therebetween, <FIG>), and then applying the frangible heat seal <NUM>. A dry wiper <NUM> is then placed in the interior space 274b of the second compartment <NUM> and the bottom transverse side is heat sealed to fully enclose the wiper <NUM> in the second compartment <NUM>. A laser score <NUM> can be formed along at least a portion of the second compartment <NUM>, here shown extending transversely across the entire width of the pouch <NUM>. In addition, a valve <NUM> is placed at the top transverse side, and the entire top transverse side of the two layers <NUM>, <NUM> is heat sealed to engage the valve <NUM> at the top of the first compartment <NUM>. The entire pouch <NUM> is then sterilized by irradiation.

At this point, a liquid is filled into the interior space of the first compartment <NUM> via the valve <NUM>. The liquid is a disinfectant such as a bleach, which is filtered and aseptically filled inside a clean room into the first compartment <NUM>. The pouch <NUM> is then packaged for delivery to a clean room for use, such as by being successively double bagged in two polyethylene bags and placed in a plastic liner and then a cardboard box for delivery.

The frangible seal <NUM> is weaker than the outer perimeter heat seals. The frangible seal <NUM> can be formed, for instance, by bonding at a lower heat. When the wiper <NUM> is ready for use, the user opens the outer packages. The user then presses on the first and/or second compartments <NUM>, <NUM>, which breaks the frangible seal <NUM>. The interior space 274a, 274b of the first and second compartments <NUM>, <NUM> are then in liquid communication with one another, whereby breaking the seal <NUM> releases the liquid from the first compartment <NUM> to come into contact with the wiper(s) <NUM> in the second compartment. The frangible seal <NUM> does not weaken the outer plastic layers forming the pouch <NUM>, so that the pouch <NUM> is liquid-proof and no liquid escapes out of the pouch <NUM>. Once the liquid has been absorbed by the wiper <NUM>, the user opens the second compartment <NUM> along the laser score <NUM>. The user then removes the wet wiper <NUM> from the interior space <NUM>, for use in the clean room.

In this manner, the liquid does not come into contact with the wiper <NUM> until just prior to the wiper <NUM> being used, which can be important where the liquid (such as a bleach) can otherwise degrade the wiper <NUM>. That extends the shelf life of the product. It is further noted that the pouch <NUM> can be formed in any suitable manner, though the frangible heat seal <NUM>, score <NUM> and two longitudinal seals can be made prior to introducing the wiper <NUM> so that the wiper <NUM> does not inadvertently get caught in or otherwise damaged by any of those operations. However, the bottom transverse side and the two longitudinal sides can be heat sealed. The wiper <NUM> can then be placed inside the pouch <NUM> and the frangible heat seal <NUM> and top transverse heat seals applied. The wiper <NUM> can be placed between the two layers <NUM>, <NUM>, then all of the seals formed at the same time, including the frangible seal <NUM> and the heat seals along the longitudinal sides and at the top and bottom transverse sides.

The dual compartment <NUM>, <NUM> pouch <NUM> of <FIG> can be used with the second pouch <NUM> and third pouch <NUM> in the systems and methods described with respect to <FIG>. For example, the pouch <NUM> with the dry wiper <NUM> can be irradiated together with the second pouch <NUM> and third pouch <NUM>. However, the dual compartment pouch <NUM> of <FIG> also has separate utility by itself, and can be used in other suitable applications, and need not be used with the second and third pouches <NUM>, <NUM>. For example, the pouch <NUM> can be used by itself when only a single wiper is needed.

Shown and described is a pouch <NUM> having two compartments <NUM>, <NUM> separated by a frangible seal <NUM>. The two compartments <NUM>, <NUM> are directly attached to each other and separated by the frangible seal <NUM>, so that the compartments <NUM>, <NUM> are in liquid communication with one another when the seal <NUM> is opened. It should be noted that the two compartments can be placed in communication with one another in other manners without using a frangible seal, such as for example by using a valve or other connection device or coupling assembly.

In addition, it is noted that the frangible seal <NUM> is shown extending the entire width of the pouch <NUM>. It is noted that the frangible seal <NUM> need not extend the entire width. For example, part of the seal <NUM> can be a full heat seal that permanently separates the first compartment <NUM> from the second compartment <NUM>, and part of the seal <NUM> can be a frangible seal that can be opened to release liquid from the first compartment <NUM> into the second compartment <NUM>.

Still further, as shown in <FIG>, the frangible seal <NUM> seals the first layer <NUM> directly to the second layer <NUM>, which are flat, so that the two layers <NUM>, <NUM> come together at the seal. Thus, the first layer <NUM> is sealed directly to the second layer <NUM> without any other material positioned therebetween. In this manner, the seal <NUM> forms a tapered area between the first and second compartments <NUM>, <NUM>. The seal <NUM> can have any suitable thickness, either small to form a line or pinch point, or wide to form a flattened area. The seal <NUM> can have a thickness of about <NUM> (<NUM> inches), the first compartment can have a length of about <NUM> (<NUM> inches), the second compartment can have a length of about <NUM> (<NUM> inches),of and the pouch can have a width of about <NUM> (<NUM> inches) and a total length of about <NUM> (<NUM> inches). The first compartment can hold approximately <NUM> of liquid or solution, and the second compartment can hold one or more folded 12x12 knitted wipers. In addition, the seal <NUM> need not be linear, as shown, but can have other shapes such as curved. In another embodiment of the invention, the first compartment <NUM> can be the same size as the second compartment <NUM>, or a different size, either smaller or larger than the second compartment <NUM>. The first and second compartments can be generally square or rectangular, or other suitable sizes and shapes.

As noted, <FIG> shows that the longitudinal sides of the first and second layers <NUM>, <NUM> are directly heat sealed to one another. And <FIG> shows that the pouch <NUM> can have side walls that extend between the longitudinal sides of the first layer <NUM> and the second layer <NUM>, for the first compartment <NUM> and/or the second compartment <NUM>. The side walls allow the layers <NUM>, <NUM> to separate at the longitudinal sides so that they can retain more liquid, substance or product in the compartments <NUM>, <NUM>. The side walls are heat sealed to the first and second layers <NUM>, <NUM>. For example, the side wall can be substantially rectangular and tapered to a point or oblong, with a first longitudinal side that couples to the first layer <NUM> and a second longitudinal side that couples to the second layer <NUM>. There can be one side at each longitudinal side of the pouch <NUM>, that gets sealed in the middle by the frangible seal <NUM>, or two longitudinal sides, one for the first compartment <NUM> and one for the second compartment <NUM>. In operation, the sides can be heat sealed to the layers <NUM>, <NUM> in a single heat-sealing operation that applies a heat seal to each longitudinal side of the side wall, or two heat-sealing operations, one that applies a heat seal to the first longitudinal side and a second that applies a heat seal to the second longitudinal side.

Additional transverse frangible seals can be provided to define more than two liquid-tight compartments in the pouch. For example, a first compartment containing a first product (e.g., dry wipe), liquid or substance; a second compartment containing a second product, liquid or substance, and a third compartment containing a third product, liquid or substance. The compartments can be arranged so that they all communicate with each other when the frangible seals are broken, or that the second compartment is positioned between the first and second compartments, so that the first and third compartments only communicate with the second compartment. And, the frangible seals can have different breaking points or separately broken, so that, for example, a first frangible seal can be broken to release the content from a first compartment into a second compartment, then a second frangible seal can be broken to release the contents from the first and second compartments into the third compartment.

Referring to <FIG>, an embodiment of the invention is shown. A pouch <NUM> has a pouch body <NUM> formed by a first layer <NUM> and a second layer <NUM>. The pouch <NUM> has outer perimeter seals and inner seals. The outer perimeter seals are at the longitudinal and transverse sides and form the first longitudinal side or side wall <NUM>, second longitudinal side or side wall <NUM>, top end or top wall <NUM>, and bottom end or bottom wall <NUM>, and define the outer perimeter of the pouch <NUM>. The pouch is substantially rectangular in shape, whereby the top and bottom ends <NUM>, <NUM> are transverse and orthogonal to the first and second longitudinal sides <NUM>, <NUM>.

The inner seals are coupling assemblies that include an inner transverse seal <NUM> and an inner compartment seal <NUM>. The inner transverse seal <NUM> extends transversely the entire width of the pouch <NUM> from the first longitudinal side <NUM> to the second longitudinal side <NUM>. The inner transverse seal <NUM> is closer to the top end <NUM> of the pouch than it is to the bottom end <NUM> of the pouch. The inner transverse seal <NUM> is substantially parallel to the top end <NUM> and bottom end <NUM> of the pouch. The inner compartment seal <NUM> extends from about the middle of the inner transverse seal <NUM> to the top end <NUM> of the pouch, substantially parallel to the longitudinal sides <NUM>, <NUM>, so that the third compartment <NUM> is longer than the first and second compartments <NUM>, <NUM>.

The inner seals and the outer perimeter seals together form the various internal compartments of the pouch <NUM>. In the embodiment shown, the inner seals form a first compartment <NUM> having a first interior space, a second compartment <NUM> having a second interior space, and a third compartment <NUM> having a third interior space. The first compartment <NUM> retains a first liquid.

In the embodiment illustrated, the inner compartment seal <NUM> is at the center of the inner transverse seal <NUM> and top end <NUM> so that the first and second compartments <NUM>, <NUM> are equal in size. However, the inner compartment seal <NUM> can be formed closer to one longitudinal side <NUM>, <NUM> so that the first and second compartments <NUM>, <NUM> have different size. Still further, other interior seals can be provided that define additional compartments. And while the compartments <NUM>, <NUM>, <NUM> are shown being arranged side by side, compartments can be formed entirely within other compartments. Though the inner seals <NUM>, <NUM> are shown touching one another, the seals can be formed at any suitable location and need not touch one another. Thus, there are a wide variety of configurations for the compartments.

As further shown, a first port or valve <NUM> is provided at the first compartment <NUM>, and a second port or valve <NUM> is provided at the second compartment <NUM>. The valves <NUM>, <NUM> are one-directional and allow liquid to be filled into the first and second interior spaces of the first and second compartments <NUM>, <NUM>. Though the valves <NUM>, <NUM> are shown at the top end <NUM> of the pouch, the valves can be provided elsewhere such as at either the front face (i.e., formed in the first layer <NUM>) and/or the rear face (i.e., formed in the second layer <NUM>) of the pouch.

The first and second seals <NUM>, <NUM> can be configured so that they can be broken separately, for example the first seal <NUM> can be broken without breaking the second seal <NUM>. For example, the first seal <NUM> can be weaker than the second seal <NUM>. Or, the first seal <NUM> can be placed sufficiently apart from and/or at an angle to the second seal <NUM>. Thus, the user can engage the pouch body <NUM> adjacent the respective seals <NUM>, <NUM> to selectively break the first seal <NUM> without breaking the second seal <NUM>, to combine the bleach contained in the first compartment <NUM> with the WFI contained in the second compartment <NUM> and allow the bleach and WFI to mix together. The user can then subsequently break the second seal <NUM> to release the combined bleach and WFI formulation onto the dry wipe <NUM>.

The third compartment <NUM> retains a dry wipe <NUM>, in the third interior space. The compartments <NUM>, <NUM>, <NUM> are liquid tight and separate from one another. In this way, the third compartment <NUM> is kept separate from the liquids in the first and second compartments <NUM>, <NUM>, so that the wipe is dry during manufacture, transport and storage. The liquids can be mixed and introduced to the dry wipe <NUM> just prior to use, to avoid degradation of the wipe <NUM> and increase shelf life. When the pouch <NUM> is ready for use, the inner seals <NUM>, <NUM> can be opened to saturate the wipe 302with the liquids contained in the first and second compartments <NUM>, <NUM> to deactivate and/or decontaminate hazardous drugs in a clean room environment and disinfect the work surface. It is noted that the various sides or ends of the pouch and compartments comprise walls.

An access or cover <NUM> is provided in the third compartment <NUM> that allows wipes <NUM> to be removed when ready for use. In the embodiment shown in <FIG>, the cover <NUM> is a press and seal covering. An opening <NUM> is formed in the top layer <NUM> of the third compartment <NUM>. The cover <NUM> is larger than the opening <NUM> and applied over and around the opening <NUM>. The cover <NUM> has an access tab <NUM> that can be opened by the user and then closed and resealed. Thus, when the user is ready to remove wipes, the user opens the third compartment <NUM> by peeling back the access tab <NUM>, revealing the saturated wipes <NUM>. The user then removes the desired number of wipes <NUM> by pulling them through the opening <NUM> and the access tab opening, and presses the access tab <NUM> back into position to seal closed the third compartment <NUM>.

In an alternative embodiment, the peel and seal cover <NUM> need not be provided. Instead, the user can access the wipe <NUM> by having a notch or perforation in the side <NUM> of the third compartment <NUM>. The notch can be formed in the side <NUM> of the third compartment <NUM>, so that the user can tear open the third compartment <NUM> by pulling on the side of the pouch at the notch. Thus, in use, the technician pulls the pouch along the perforation in order to tear the two layers of the pouch open to access the saturated wipe contained therein.

Thus, the first compartment <NUM> has a bottom side or end <NUM> formed by the inner transverse seal <NUM>, a first longitudinal side <NUM> formed by a portion of the pouch first longitudinal side <NUM>, a top side or end <NUM> formed by a portion of the pouch top end <NUM>, and a second longitudinal side <NUM> formed by the inner compartment seal <NUM>. As further shown, the inner compartment seal <NUM> can formed as a burst or frangible seal that is configured to open upon the user applying a certain amount of pressure to the seal <NUM>. The frangible seal can comprise the entire inner compartment seal <NUM> or, as shown, only a portion of the inner compartment seal <NUM>. The inner compartment seal <NUM> can form an entirety of the second longitudinal side wall <NUM>, or as shown only a portion of the second longitudinal side wall <NUM>.

The second compartment <NUM> has a bottom side or end <NUM> formed by the inner compartment seal <NUM>, a first longitudinal side <NUM> formed by the inner compartment seal <NUM>, a top side or end <NUM> formed by a portion of the top end <NUM>, and a second longitudinal side <NUM> formed by a portion of the pouch second longitudinal side <NUM>. The third compartment <NUM> has a bottom side or end <NUM> which is the bottom pouch end <NUM>, a first longitudinal side <NUM> formed by a portion of the pouch first longitudinal side <NUM>, a top end or side <NUM> formed by the inner transverse seal <NUM>, and a second longitudinal side <NUM> formed by a portion of the pouch second longitudinal side <NUM>. Thus, the pouch first side <NUM> forms the first longitudinal sides <NUM>, <NUM> of the first and third compartments <NUM>, <NUM>, and the pouch second longitudinal side <NUM> forms the first longitudinal sides <NUM>, <NUM> of the second and third compartments <NUM>, <NUM>. And the pouch top end <NUM> forms the top end <NUM>, <NUM> of the first and second compartments <NUM>, <NUM>. The inner transverse seal <NUM> can form an entirety of the bottom <NUM>, or as shown only a portion of the bottom <NUM>.

In order to introduce the pouch <NUM> into the clean room, it (and its contents) must first be sterilized. In one embodiment, parts of the pouch <NUM> is irradiated to avoid introducing contaminants into the environment. The wipe <NUM> and WFI in the second compartment <NUM> are terminally irradiation sterilized, such as by the methods described herein. Thus, the pouch <NUM> may undergo known terminally irradiation sterilization. The first compartment <NUM>, however, contains a chemical (i.e., bleach) that cannot be terminally irradiation sterilized. As such, the pouch <NUM> is configured such that the chemical can be added into the first compartment <NUM> after the wipe <NUM> in the third compartment <NUM> has been sterilized.

The pouch <NUM> is designed with a first and second one-way valve <NUM>, <NUM> respectively positioned at a top end <NUM>, <NUM> of each of the first and second compartments <NUM>, <NUM>. This valve <NUM>, <NUM> only allows fluids to be transferred through it in one direction. As such, the pouch <NUM>, containing only a dry wipe <NUM> in the third compartment <NUM> and optionally WFI in the second compartment <NUM>, may be terminally irradiation sterilized. Then, when the pouch <NUM> is transferred to the clean room, the first compartment <NUM> is aseptically filled with sterilized bleach via the first one-way valve <NUM> to saturate the dry wipe contained therein. The sterilized bleach solution may be of any concentration determined suitable to one or ordinary skill in the art. At this point, the pouch <NUM> is fully ready for use in a clean room. The wipes contemplated for the assembly may be of any conventional size known in the art, exemplarily <NUM> × <NUM>, <NUM> × <NUM>, <NUM> × <NUM>, <NUM> × <NUM>, <NUM> × <NUM> (<NUM>" × <NUM>", <NUM>" × <NUM>", <NUM>" × <NUM>", <NUM>" × <NUM>").

A process of preparing the pouch <NUM> is outlined here. The steps can be performed sequentially or at the same time. As set forth more fully below, each of the steps utilizes the chemicals and materials described above. The layers <NUM>, <NUM> of the pouch body <NUM> are hermetically heat sealed along the left side <NUM>, <NUM>, right side <NUM>, <NUM>, top <NUM>, <NUM> and bottom <NUM>, as well as the interior walls <NUM>, <NUM>, <NUM>, to form the respective sides of the pouch and compartments. The first and second ports <NUM>, <NUM> are integrally sealed to the top end <NUM>, <NUM> of the first and second compartments <NUM>, <NUM>, respectively. The first and second burst seals <NUM>, <NUM> are then formed in the pouch body <NUM>.

At this stage, the right side <NUM> of the third compartment <NUM> has an opening <NUM> in it so that the dry wipes <NUM> are placed in the third compartment <NUM>. The right side of the third compartment <NUM> is then hermetically sealed to form a closed or sealed third compartment. At this point, there are no chemicals present in the pouch <NUM>. Optionally, WFI can be filled into the second compartment through the second port <NUM> at this time. The sealed pouch <NUM> is then assembled in preparation for irradiation sterilization. For example, the pouch <NUM> can be placed in a first plastic bag and the first plastic bag is then hermetically sealed to form a first closed or sealed pouch enclosure. Optionally, the first sealed pouch enclosure can be placed in a second container such as a second plastic bag and the second plastic bag is then hermetically sealed to form a second closed or sealed pouch enclosure. In one embodiment, the first and second plastic bags are a polyethylene bag that is heat sealed. The second (or first) sealed pouch enclosure is then placed into a plastic liner bag (e.g., a polyethylene bag) which is closed and placed into a box or other container. The liner is then closed (such as by being knotted or by a fastener (tie)) and the box is closed to form a closed package. The box and the enclosed contents are then terminally irradiation sterilized using known techniques and equipment, and can be shipped to an irradiator for sterilization, to form a sterilized closed container. The irradiation sterilizes the container and its contents, including the plastic bags, wipes, pouches, solutions.

The irradiated boxes (sterilized closed containers) are then transferred to a clean environment and the sterilized closed pouch enclosure is removed from the plastic liner bag. The sterilized pouches <NUM> are then removed from the inner-most sealed plastic bag. At this point, the bleach is aseptically filled into the first compartment <NUM> via the one-way valve <NUM> inside the clean room. In addition, if the WFI has not previously been filled into the second compartment <NUM>, it can be filled at this point through the second port <NUM>. The valves <NUM>, <NUM> may close automatically by virtue of its design, though other suitable valve designs can be provided.

Once the valves <NUM>, <NUM> are closed, the pouch <NUM> forms a closed or sealed filled pouch that is then ready for use as well. Optionally, the pouch <NUM> can be successively hermetically sealed in a first container and optionally then a second container, such as plastic or polyethylene bags to form a first (and second) first filled pouch enclosure. Multiple wipe pouches <NUM> are then placed together into a carton having a plastic liner. The plastic liner can be closed (such as by being knotted or by a fastener (tie)) and the box is closed to form the final closed package. The box can then be shipped to the customer for use.

Alternate processes of preparing the pouch <NUM> may also be performed. For example, the heat seals and burst seals can be performed in any order. In addition, it will further be appreciated that other suitable techniques can be utilized to irradiation sterilize the pouch <NUM>. For instance, the multiple pouches <NUM> can be heat sealed in the same or different individual first (and optionally second) plastic bags. In one embodiment, each pouch <NUM> can be individually single / double bagged (i.e., heat sealed in a first plastic bag (and optionally a successive second plastic bag) to form respective first and second sealed enclosures for the first, second and third closed pouches), then placed in a carton liner and a box and sterilized.

A method of using the pouch <NUM> is outlined here. Once the box arrives at the customer, the box and box liner are opened (e.g., in a clean room or staging area). A pouch <NUM> can then be removed from the box for use, and brought into the clean room. The heat-sealed bags are opened and the pouches <NUM> are removed. The user then breaks the first burst seal <NUM> between the first and second compartments <NUM>, <NUM>, introducing the bleach into the WFI. Once the bleach and WFI are mixed, the user breaks the second burst seal <NUM> between the second and third compartments <NUM>, <NUM>, introducing the bleach/WFI mixture onto the wipe <NUM>. Once the wipes <NUM> are saturated with the mixed bleach and WFI, the user opens the third compartment <NUM> (e.g., by opening the access tab <NUM> or tearing a perforation) and the diluted bleach saturated wipe is removed. The wipe is then applied to the contaminated work surface to clean the hazardous drug(s).

The first, second, and third compartments <NUM>, <NUM>, <NUM> are completely liquid tight, including all of the outer perimeter seals and internal seals, so that liquid cannot pass from the first compartment <NUM> to the second compartment <NUM>, or vice versa, or otherwise escape the pouch <NUM>. And liquid cannot pass from either the first and second compartments <NUM>, <NUM> to the third compartment <NUM>.

The burst seals <NUM>, <NUM> are frangible and weaker than the outer perimeter heat seals for the longitudinal sides <NUM>, <NUM> and the top and bottom <NUM>, <NUM>. The frangible seals <NUM>, <NUM> can be formed, for instance, by bonding at a lower heat, and the first burst seal <NUM> can be at a lower heat than the second burst seal <NUM> so that the first burst seal is weaker than the second burst seal. When the wiper <NUM> is ready for use, the user opens the outer packages. The user then presses on the first and/or second compartments <NUM>, <NUM>, which breaks the first frangible seal <NUM>. The interior space of the first and second compartments <NUM>, <NUM> are then in liquid communication with one another, whereby breaking the seal <NUM> releases the liquid from the first compartment <NUM> to come into contact with the liquid in the second compartment <NUM>.

The user then presses on the second or third compartments <NUM>, <NUM>, which breaks the second frangible seal <NUM>. The interior space of the second and third compartments <NUM>, <NUM> are then in liquid communication with one another, whereby breaking the seal <NUM> releases the liquid from the first and second compartments <NUM>, <NUM> to come into contact with the wiper in the third compartment <NUM>. The frangible seals <NUM>, <NUM> do not weaken the outer plastic layers forming the pouch <NUM>, so that the pouch <NUM> is liquid-proof and no liquid escapes out of the pouch <NUM>. Once the liquid has been absorbed by the wiper <NUM>, the user opens the third compartment <NUM> at the press and seal cover <NUM>. The user then removes the wet wiper <NUM> from the interior space, for use in the clean room.

In this manner, the liquid does not come into contact with the wiper <NUM> until just prior to the wiper <NUM> being used, which can be important where the liquid (such as a bleach) can otherwise degrade the wiper <NUM>. That extends the shelf life of the product. It is further noted that the pouch <NUM> can be formed in any suitable manner, though the frangible heat seals <NUM>, <NUM>, and outer perimeter seals can be made prior to introducing the wiper <NUM> so that the wiper <NUM> does not inadvertently get caught in or otherwise damaged by any of those operations. However, in another embodiment, the bottom transverse side and the two longitudinal sides can be heat sealed. The wiper <NUM> can then be placed inside the third compartment <NUM> and the frangible heat seals <NUM>, <NUM> and top transverse heat seals applied. In another embodiment of the invention, the wiper <NUM> can be placed between the two plastic layers, then all of the seals formed at the same time, including the frangible seals and the heat seals along the longitudinal sides and at the top and bottom transverse sides.

It is further noted that the invention is shown and described as a pouch <NUM> having compartments <NUM>, <NUM>, <NUM> separated by the frangible seals <NUM>, <NUM>. The compartments <NUM>, <NUM>, <NUM> are directly attached to each other and separated by the frangible seals <NUM>, <NUM>, so that the compartments <NUM>, <NUM>, <NUM> are in liquid communication with one another when the seals <NUM>, <NUM> is opened. It should be noted that the compartments can be placed in communication with one another in other manners without using a frangible seal, such as for example by using a valve or other connection device or coupling assembly.

In addition, while both the first and second compartments <NUM>, <NUM> are shown having ports <NUM>, <NUM>, only one of those compartments can have a port. For example, the second compartment <NUM> contains WFI, which can be irradiation sterilized. In one embodiment, the WFI can be filled into the second compartment <NUM> as the compartment is formed so that no port is needed, and the WFI can be irradiation sterilized at the same time that the dry wipe <NUM> is irradiation sterilized. The first port <NUM> can subsequently be used to aseptically fill the first compartment <NUM> with bleach, which cannot be irradiation sterilized.

It is further noted that a frangible seal <NUM> is placed between the first and second compartments, and that there is no frangible seal between the first and third compartments. Rather, the seal <NUM> between the first and second compartments does not break open during use, and stays intact and unbroken during use. In this manner, the chemicals in the first and second compartments can be mixed together before they are introduced to the wipe <NUM> in the third compartment. In addition, there is no direct liquid flow communication between the first and third compartments <NUM>, <NUM>. Rather, liquid in the first compartment <NUM> cannot reach the third compartment <NUM> without first flowing through the second compartment <NUM>. The most degrading chemical, bleach, is contained in the first compartment <NUM> so that it doesn't degrade the wipes <NUM> in the event that the second frangible seal <NUM> breaks at the same time or before the first frangible seal <NUM>.

Still further, the first layer <NUM> is sealed directly to the second layer <NUM> without any other material positioned therebetween. In this manner, the frangible seals <NUM>, <NUM> forms a tapered area between the compartments <NUM>, <NUM>, <NUM>. The seals <NUM>, <NUM> can have any suitable thickness, either small to form a line or pinch point, or wide to form a flattened area. In one embodiment, the pouch <NUM> can have a length of <NUM> (<NUM> inches), and a width of <NUM> (<NUM> inches), and the first compartment can have a length of about <NUM> (<NUM> inches), the third compartment can have a length of about <NUM> inches. <NUM> (<NUM> inches). The first and second compartments can each hold approximately <NUM> of liquid or solution, and the third compartment can hold one or more folded 12x12 knitted wipers. In addition, the seals need not be linear, as shown, but can have other shapes such as curved. In another embodiment of the invention, the first compartment can be the same size as the second compartment, or a different size, either smaller or larger than the second compartment. The first, second and third compartments can be generally square or rectangular, or other suitable sizes and shapes.

<FIG> show another example embodiment of the invention. Here, the two top compartments are shown having different sizes. The top left compartment is larger than the top right compartment, but smaller than the bottom compartment. The top left and top right compartments have the same height, but the left compartment is wider than the right compartment. This can be done, for example, where the left compartment holds a diluent liquid such as water for injection (WFI), and the right compartment holds a concentrate, such as bleach. In one embodiment, the sizes and dimensions shown in <FIG>. In operation, the user rolls the pouch from the top left corner. That forces the liquid in the top left compartment toward the right, which also increases the pressure in the top left compartment. That pressure continues to build up until eventually the frangible or burst seal between the two top compartments breaks, releasing the WFI into the concentrate.

Thus, those liquids are mixed together by pressing on the pouches. When they are thoroughly mixed, the user can continue rolling the pouch from the top left corner or from the top, until the burst seal between the top right compartment and the lower compartment breaks open, releasing the mixed composition into the lower compartment. The mixed composition then contacts and saturates the wipers. The wipers can then be removed by opening the top access tab <NUM>. <FIG> is one example embodiment, and other relative sizes, shapes and dimensions can be provided between the compartments, and any number of compartments can be provided.

<FIG> shows another pouch. Here, the pouch is similar to the embodiments of <FIG>, <FIG>. A tab <NUM>, <NUM> extends inward from each of the two longitudinal sides <NUM>. An internal burst seal extends transversely between the two tabs <NUM>, <NUM> and connect to the inward distal end of the two tabs <NUM>, <NUM>. The tabs <NUM>, <NUM> can be relatively short and substantially shorter than the burst seal <NUM>, such that the burst seal <NUM> nearly extends the entire width of the pouch so that the tabs <NUM>, <NUM> do not impede liquid moving from the top compartment to the bottom compartment once the seal is burst. However, the tabs <NUM>, <NUM> can be longer, such that the tabs <NUM>, <NUM> are burst seal <NUM>.

The pouch of <FIG> does not include a tear line or score <NUM> to remove the wipes, as in <FIG>, <FIG>. Instead, a peel and seal opening cover <NUM> (similar to the cover <NUM> of <FIG>) is provided. In addition, the opening <NUM> of <FIG> is not provided. Instead, the right longitudinal side <NUM> is continuous and is heat sealed, and the bottom end <NUM> opens between the layers <NUM>, <NUM> and heat sealed once the wipes are placed inside the bottom compartment.

Finally, it is noted that the description and claims use several geometric or relational terms, such as parallel, linear, curved, rectangular, perpendicular, and flat. In addition, the description and claims use several directional or positioning terms and the like, such as top, bottom, sides, longitudinal, transverse, and interior. Those terms are merely for convenience to facilitate the description based on the embodiments shown in the figures. Those terms are not intended to limit the invention. Thus, it should be recognized that the invention can be described in other ways without those geometric, relational, directional or positioning terms. In addition, the geometric or relational terms may not be exact. For instance, walls may not be exactly perpendicular or parallel to one another but still be considered to be substantially perpendicular or parallel because of, for example, roughness of surfaces, tolerances allowed in manufacturing, etc. And, other suitable geometries and relationships can be provided without departing from the spirit and scope of the invention.

Claim 1:
A wipe pouch (<NUM>), comprising:
a first compartment (<NUM>) containing a first liquid chemical, said first compartment (<NUM>) having a one-way fill valve (<NUM>) whereby the first liquid chemical is filled into the first compartment (<NUM>) following irradiation sterilization of the wipe pouch (<NUM>);
a second compartment (<NUM>) containing a second liquid chemical that is present during irradiation sterilization of the wipe pouch (<NUM>);
a third compartment (<NUM>) containing a dry wipe (<NUM>) that is present during irradiation sterilization of the wipe pouch (<NUM>);
a first coupling assembly coupling the first compartment (<NUM>) to the second compartment (<NUM>) and having a closed configuration in which the first compartment (<NUM>) does not communicate with the second compartment (<NUM>), and an opened configuration in which the first compartment (<NUM>) communicates with the second compartment (<NUM>); and
a second coupling assembly coupling the second compartment (<NUM>) to the third compartment (<NUM>) and having a closed configuration in which the second compartment (<NUM>) does not communicate with the third compartment (<NUM>), and an opened configuration in which the second compartment (<NUM>) communicates with the third compartment (<NUM>).