Patent Publication Number: US-2022234808-A1

Title: Wipe container

Description:
RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/072,832, filed Oct. 30, 2014, the entire contents of which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a container for holding one or more wipes saturated with a cleaning agent and the container being suitable for dispensing the wipes in a clean room environment. 
     BACKGROUND OF THE INVENTION 
     A clean room environment is a room designed, maintained, and controlled to prevent particle and microbiological contamination from entering or residing in products that will be manufactured in the controlled environment. There are different levels of cleanliness in clean rooms, generally in the range of a ISO 5, Grade A, Class 100 room (i.e., a room having 100 particles of 0.5 micron and larger, per cubic foot of air), to a ISO 8, Grade D, Class 100,000 clean room. Clean rooms are used for a variety of purposes, including to manufacture pharmaceutical products and electronics, such as semiconductors. Clean rooms have to maintain a high level of cleanliness, or risk large financial losses. If a product being developed or manufactured in a clean room becomes contaminated, the entire product in the clean room must often be discarded. 
     The U.S. Food and Drug Administration (“FDA”) requires firms to assure that every element of the manufacturing environment and manufacturing process are proven to be acceptable to FDA requirements and industry standards. The FDA requires firms to operate in accordance with Current Good Manufacturing Practices (CGMP). To do this, firms are required to assure that products, personnel, training, ingredients, procedures and systems used in the manufacture of a drug product have undergone stringent testing. In light of the strict standards that clean rooms must satisfy, companies are very reluctant to introduce new products into their clean rooms that have not been extensively tested and proven reliable. 
     It would not be acceptable if the manufacturing method resulted in a product that might contaminate a clean room. Certain chemicals are used inside a clean room to disinfect the clean room. However, some chemicals can lose effectiveness or become unstable after a short period of time (e.g., 20-30 days) once the chemical is mixed or when the chemical is saturated onto a wipe. Consequently, those chemical compositions need to be diluted just prior to use or introduced onto a wipe just prior to use. Yet, it is particularly difficult and time-consuming to dilute chemical compositions and/or to saturate a wipe inside a clean room because of possible contamination of the chemicals by the environment and because the user is outfitted in sterile garments and gloves. 
     Controlled or clean environments, such as hoods, clean rooms or facilities have strict requirements for cleanliness, particularly requiring surfaces to be cleaned often and on a consistent basis. Conventional packaged saturated wipes may be not sufficiently sterile for a clean room or are easily contaminated because of design of the package and/or because the chemical interacts with the structure of the wipe or other chemicals on the wipe. Also the wipes in conventional packages often deteriorate or lose the potency of the active ingredient(s) of the cleaning agent. Additionally, some cleaners are mixed with water just prior to use inside clean room, which is time-consuming and labor-intensive. Cleaners also have a short shelf life after mixing; and the exact amount of water to cleaner must be precisely measured. Many sanitizers, disinfectants and sporicides used in saturated wipes have the inability to be mixed with water for extended time periods. This stability problem relates to the degradation of the active ingredients over time in the solution and is further complicated by the presence of the wiping material, wiping material additives and air in the package. 
     Examples of conventional wipes containers include U.S. Pat. Nos. 8,038,000; 7,850,041; 7,681,725; 7,357,248; 6,866,145; 6,827,080; 6,001,187; 5,988,371; and 5,814,159, the subject matter of each of which is herein incorporated by reference. 
     Therefore, a need exists for a sterile wipe container that reduces deterioration of the wipes and associated cleaning agent. 
     SUMMARY OF THE INVENTION 
     Accordingly, the present invention may provide a wipe container that includes a cover member that has a cavity, at least one wipe received in the cavity of the cover member, a base member has a fluid reservoir, and a partition is disposed between the cover and base members, wherein the cover member, the base member, and the partition are sealed together to create a perimeter seal. 
     The present invention also may a wipe container configured and suitable for use in a clean room that comprises, a cover member that has a cavity, at least one wipe received in the cavity, a base member that has a fluid reservoir and at least one puncture member, and a partition disposed between the cover and base members. The partition is formed of a membrane that can be split open by the at least one puncture member of the base member. At least one fill port is in fluid communication with the fluid reservoir. Wherein the cover and the base members are sealed together to create a perimeter seal and the at least one fill port is disposed in the perimeter seal. 
     The present invention may further provide a method of loading a wipe container that comprises the steps of providing a container that has a cover member and a base member; loading at least one wipe into a cavity of the cover member of the container; sealing a partition between the cover and base members of the container creating a seal around a perimeter of the container; and filling a reservoir in the base member of the container with a fluid through at least one fill port in the seal. 
     Other objects, advantages and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses a preferred embodiment of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       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: 
         FIG. 1  is a perspective top view of a wipe container in accordance with an exemplary embodiment of the present invention; 
         FIG. 2  is a perspective bottom view of the wipe container illustrated in  FIG. 1 ; 
         FIG. 3  is an exploded perspective view of the wipe container illustrated in  FIG. 1 ; 
         FIG. 4  is a bottom plan view of the wipe container illustrated in  FIG. 1 ; 
         FIG. 5  is a cross-sectional view of the wipe container illustrated in  FIG. 1 , showing the container prior to puncture of a partition; 
         FIG. 6  is a cross-sectional view of the wipe container illustrated in  FIG. 5 , showing the container after puncture of a partition; 
         FIG. 7A  is a perspective top view of a wipe container in accordance with an alternative embodiment of the present invention; and 
         FIG. 7B  is a perspective bottom view of the wipe container illustrated in  FIG. 7A . 
     
    
    
     DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS 
     The present invention relates to a wipe container or pack that is designed to hold a cleaning agent that can be easily applied to the wipe or wipes in the container with the appropriate amount of cleaning agent. In a preferred embodiment, the container is used in a clean room or facility where extreme cleanliness is a necessity. The container of the present invention is configured to isolate the wipes and the cleaning agent until needed for cleaning, thereby reducing degradation of both the wipes and the cleaning agent. This is particularly useful when the cleaning agent degrades when it is mixed with the wipes, chemicals in the wipes, or water in the wipes. By keeping the cleaning agent and the wipes separated, it is possible to maintain the effectiveness of the cleaning agent until it is ready to be used. 
     Referring to  FIGS. 1-3 , the container  100  of the present invention generally includes a cover member  102  sealed to a base member  104  and a partition  106  therebetween. The partition  106  is preferably a membrane that is fluid impregnable. The cover member  102  holds one or more wipes  110  and the base member  104  holds a cleaning agent or fluid  120  ( FIG. 5 ). The container  100  preferably incorporates one or more puncture members  130 A and  130 B to split the partition  106  open (preferably along a line) when desired, thereby allowing the cleaning agent or fluid  120  to combine with the wipes  110 . The opening of the partition  106  does not create any particles that might enter the fluid  120  or wipes  110  or otherwise contaminate the fluid  120  and/or wipes  110 . The cover  102  and base  104  can be formed of a polypropylene (PP) or high density polyethylene (PE) material, or other suitable materials. 
     The cover member  102  with one or more sides and a top, defines a cavity  140  ( FIG. 5 ), sized to hold the one or more wipes  110 . The wipes  110  may be any conventional wipe suitable for cleaning surfaces, such as a cloth, polyester, nylon, or the like fabric. The wipes  110  may be dry, or treated with standard wipe chemicals, or presaturated with water to dilute the fluid  120  once mixed, or treated with chemicals to be mixed or combined with the fluid  120 . A flange  142  is provided around the perimeter of the cover member  102  for sealing to the base member  104  and extends outward. One or more tabs  144  extend from at least one side of the perimeter flange  142 , as seen in  FIGS. 1 and 2 . The cover member is preferably provided with a dispensing slot or opening  146  for retrieval and dispensing of the wipes  110 . An adhesive cover sheet  148  is provided over the dispensing slot  146 , which can be peeled off to dispense the wipes  110 . The sheet  148  seals to the top surface of the cover member  102  about the dispensing slot or opening  146 . 
     The base member  104  has one or more sides and a bottom, and includes a reservoir  150  ( FIGS. 3 and 5 ), for holding the cleaning fluid  120 . The cleaning fluid  120  may be any cleaning agent or solution that is suitable for cleaning contaminants, particularly contaminants found in a clean room. For example, the cleaning fluid  120  may be hydrogen peroxide, phenol, paracetic acid/hydrogen peroxide, quaternary ammonium, bleach, peroxide, surfactant based cleaners, and thiosulfate, or any chemical that has the inability to remain stable when mixed with water or a second chemical agent, or the like, though certain agents might be less suitable or require a special wiper, such as chlorine (which may bond to the wiper) and bleach (which may degrade a polyester wiper). Like the cover member  102 , the base member  104  includes a perimeter flange  152  with one or more tabs  154  extending from a side thereof. 
     The one or more puncture members  130 A and  130 B are located on the base member  104  preferably between the reservoir  150  and the perimeter flange  152 . As best seen in  FIGS. 4 and 5 , the puncture members  130 A and  130 B are respectively positioned near each end of the container and toward one side and adjacent to the partition  106 . The puncture members  130 A and  130 B are inset with respect to the reservoir  150 , so users can readily locate the puncture members with their fingers. Each puncture member  130 A and  130 B is formed of a flexible material, such as plastic, and is shaped similar to a convex dome before activation ( FIG. 5 ). The puncture member  130  has a dome portion  132  and a puncture portion  134  located at center of the dome portion  132 . The puncture portion  134  extends outward from the dome portion  132  (upward in embodiment of  FIG. 5 ). The puncture portion  134  can be sharp or rounded. Each puncture member  130 A and  130 B may be activated by pushing the dome portion  132  from the base member side toward the cover member side (upward in embodiment of  FIG. 5 ). This pushes the puncture portion  134  outward. In the ready state ( FIG. 5 ), the dome portion  132  is inverted and the puncture portion  134  is receded; in the activated state ( FIG. 6 ), the dome portion  132  and the puncture portion  134  are pushed outward until the puncture portion extends through and pierces the partition  106 , as seen in  FIG. 6 . 
     The partition  106  is preferably taut such that the puncture members  130 A and  130 B slice, pierce or split open the partition  106  along the length of the container  100  for substantially the entire distance between the puncture member  130 A and the second puncture member  130 B, thereby allowing the fluid  120  in the reservoir  150  to enter the cavity  140  and combine with the wipes  110  and/or any water that is on the wipes  110  or in the cavity  140 . By having two puncture members, the partition  106  can be split the entire length between them. The partition  106  material and the puncture members  130  do not create any particles of the partition  106  that could contaminate the fluid  120  and/or wipes  110 . The user may push both puncture members  130 A and  130 B at the same time. A tri-legged slot  162  ( FIGS. 2 and 4 ) is be added to each puncture portion  134  to facilitate activation and pushing through of the dome portion  132  so that puncture portion  134  can pop out. The partition  106  is preferably formed of any fluid impregnable material, such as foil, polyethylene film, polypropylene film, or the like, that can be split open, and that also resists corrosion from the cleaning fluid  120 . 
     In one embodiment, the wipes can be treated with sodium thiosulfate and the cleaning fluid  120  is bleach. When the bleach is combined with the wipes, the sodium thiosulfate should be sufficient to bring the pH to about 1-3, and more preferably to about 2. At this pH, the bleach is a more efficient cleaning agent. Notably, however, the bleach at a 2 pH does not last very long, whereas bleach at a higher pH (such as about 11-12) has a longer shelf life (but is less effective as a cleaning agent). Thus, the invention is able to provide the bleach wipe at lower pH levels that are more effective for cleaning purposes, at a long shelf life since the bleach is not mixed with the acid until it is ready to be used. 
     In another embodiment, the wipes are dry or treated with water and the cleaning fluid  120  is phenol, hydrogen peroxide, or paracetic acid/hydrogen peroxide. Here, the dry or water containing wipes may contain chemicals that are used in the normal treatment of the wipes, e.g. chemicals used to soften the wipes. 
     To load the container  100 , the wipes  110  are loaded into the cavity  140  of the cover member  102 . The cover member  102 , partition  106 , and base member  104  are then sealed together at the perimeter thereof such that the perimeter flanges  142  and  152  and the perimeter of the partition  106  are sealed together and the corresponding tabs  144  and  154 . Any sealing method may be used, such as heat sealing. The sealing step separates the reservoir  150  and the cavity  140  (by the partition  106 ), and extends the shelf life of the wipes and fluid. The partition  106  completely seals the cavity  140  from the reservoir  150  so that the wipe  110  (dry or presaturated) and the cleaning fluid  120  cannot mix and the cleaning fluid  120  cannot enter the cavity  140 . The seal also defines an inside and outside of the container  100 . The cavity  140 , reservoir  150 , wipes  110 , fluid  120  (when filled), and preferably the puncture member  130 , are located inside the container  100  (and perimeter seal). The ports  170  allow fluid to be introduced into (and air or fluid to be removed from, as needed) the cavity  140  and/or reservoir  150  from outside the container  100 . In a preferred embodiment, the flange  142 , the flange  152 , and the partition  106  are aligned and sealed together simultaneously. The container is then sterilized by any known method, such as irradiation. 
     Following irradiation, the cleaning fluid  120  can then loaded into the container  100  through one or more fill ports  170  provided in the seal of the container  100 , preferably at the tabs  144  and  154 . The ports  170  may be formed by channels in the tabs. Each port  170  is an opening that extends the entire length of tab  144  and tabs  154  to allow fluid to be intruded into the cavity  140  and reservoir  150  from the outside. Thus, the ports  170  extend from inside the perimeter seal to outside the perimeter seal. In an alternative embodiment, the ports  170  can be separate tubes that are placed in the tab channels and extend into the cavity  140  and reservoir  150 . The ports  170  enable a fluid to be introduced into the cavity  140  and/or reservoir  150  (which are inside the perimeter seal and the container) from an external source located outside the perimeter seal and container. The cleaning fluid  120  is preferably aseptically filled into the reservoir  150  through the ports  170 . For instance, a fluid filter may be provided, such as 0.22 micron filter, to remove particulates and bacteria and spores greater in size in the chemical composition, and then the fluid  120  is filled into reservoir  150 . The container can be filled through one of the ports  170  and vented through another. 
     Once the reservoir  150  is filled with the precise amount of cleaning fluid  120  for the wipes  110 , the fill ports  170  are closed and sealed. If the wipes  110  are to be saturated with water or if water (or other diluents or chemicals) are to be placed into the cavity  140  with the wipes  110 , that can be done at the same time or before/after the fluid  120  is filled into the reservoir  150  through one of the ports  170 . For instance, one port  170  can lead into the cavity  140  and one port  170  can lead into the reservoir  150 ; or, the ports  170  can each lead to the cavity  140  and reservoir  150 , separated by the partition  106 . Or, the water can be placed into the cavity  140  at the same time the wipes  110  are loaded into the cavity  140 . 
     In one embodiment, a closure valve or connector can be placed at the end of the ports  170  to operate as a closure. In this manner, the connectors can be opened and closed to open/close the ports  170 . The cavity  140  and reservoir  150  can be filled before or after irradiation. The ports  170  can be closed at all times, except when being used to fill the cavity  140  and reservoir  150 . The two halves can be formed, then tubular ports  170  placed in each half, the wipers inserted, and the membrane stretched between the two halves (i.e., placed between the two halves tightly (not loosely) so the piercing devices can cut it or otherwise create a hole or slit), and the entire package sealed together. Alternatively, the membrane and one port can be partially sealed together to create the chemical halve and the wipes placed into the other halve, which is then brought together and sealed. Once the package is fully assembled, the liquids can be filled into the cavity  140  and reservoir  150  simultaneously or sequentially, either before or after irradiation. Once the fluid is filled into the cavity  140  and reservoir, the connector can be closed or removed and the port  170  sealed closed. Any suitable connector can be utilized, such as the SPS 4 offered by IPN. 
     The container  100  can be sterilized either before or after the fluid  120  is loaded. If the cleaning fluid  120  can be irradiated, then the fluid  120  is loaded, heat sealed and irradiated. If the cleaning fluid  120  cannot be irradiated, then the container  100  is irradiated and then aseptically filled following irradiation. 
     In operation, the assembled container  100  is ready for use. The container  100  can be double-bagged in polypropylene bags and heat sealed so that they can be introduced into a controlled environment. The puncture members  130 A and  130 B are in the ready state. To use the container  100  and the wipes  110 , the puncture members  130  are activated by the user pushing them from outside the base member  104  through the partition  106  to allow the wipes  110  to be saturated by the cleaning fluid  120 . It is preferable that the wipes  110  and the fluid  120  sit for a period of time, such as five minutes, to allow the cleaning fluid  120  to completely saturate the wipes  110  (and mix with any water in the cavity) without dry spots on the wipes. Once saturated with the fluid  120 , the wipes  110  are ready for use and may be dispensed through the opening  146  in the cover member  102  after removing the adhesive sheet  148 . The container is safe to bring into or have in a clean room. The container  100  can be punctured inside the clean room and is ready to use without having to manually mix any fluid or saturate the wipes inside the clean room. 
     The container may be doubled bagged before bringing the container into the clean room, as described in U.S. Pat. No. 6,123,900 to Vellutato, herein incorporated by reference, thereby extending the life of the cleaning agent. That is the container can be encased in a first sealing layer, forming a first enclosure, and the first enclosure can be encases in a second sealing layer, forming a second enclosure. Both the first and second sealing layers provide for hermetic sealing. 
       FIGS. 7A and 7B  illustrate an alternative embodiment of the present invention. The container  200  of  FIGS. 7A and 7B  is similar to the container  100 , except that the container  200  holds only a single wipe. Like the first embodiment, the container  200  includes a cover member  202  with a dispensing opening  246  for the wipes and a base member  204  with a reservoir  250  for the cleaning fluid. The base member  204  includes one or more puncture members  230  similar to the puncture members  106  of the first embodiment for slicing open a partition between the cover and the base members  202  and  204 . One or more fluid ports  270 A and  270 B may be provided in the perimeter seal of the container  200  like the container  100  of the first embodiment. Once the port  270 A communicates with and allows first fluid (such as water) to be filled into the cover cavity and other port  270 B communicates only with and allows second fluid (such as a cleaning chemical composition) to be filled into the reservoir. 
     It is noted that the invention has been described as for use in a controlled environment such as a clean room. However, the invention need not be used in a controlled environment and need not be packaged (bagged) for use in a controlled environment. For instance, the invention can be utilized for bleach as the cleaning fluid  120  and an acid provided on or with the wipe so that bleach retains its effectiveness and the acid lowers the pH of the bleach just prior to use so that the bleach is more effective as a cleaning agent. 
     In addition, while a port  170  is shown and described as leading into each of the cavity  140  and the reservoir  150 , one or both ports  170  need not be provided. For instance, a fluid  120  can be filled in the cavity  140  and/or the reservoir  150  before it is sealed, so that a port is not needed. Still further, while the puncture member is shown and described, other suitable configurations can be provided. For instance, the puncture member need not be positioned on the base member  104 , and other suitable puncturing or slicing devices can be utilized. 
     In addition, while the container is shown and described as having a base member, the base member can be a separate container that is in fluid communication with the cover. Accordingly, the invention can have two containers, one that retains the wipes (with or without water) and one that retains the cleaning fluid. A fluid-impermeable partition is provided between the two containers and split by the user actuating a puncture member to allow fluid to pass between the two containers. 
     While particular embodiments have been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the appended claims.