RELATED APPLICATIONSThis 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 INVENTIONThe 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 INVENTIONA 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 aISO 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 INVENTIONAccordingly, 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 DRAWINGSA 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 inFIG. 1;
FIG. 3 is an exploded perspective view of the wipe container illustrated inFIG. 1;
FIG. 4 is a bottom plan view of the wipe container illustrated inFIG. 1;
FIG. 5 is a cross-sectional view of the wipe container illustrated inFIG. 1, showing the container prior to puncture of a partition;
FIG. 6 is a cross-sectional view of the wipe container illustrated inFIG. 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 inFIG. 7A.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTSThe 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 toFIGS. 1-3, thecontainer100 of the present invention generally includes acover member102 sealed to abase member104 and apartition106 therebetween. Thepartition106 is preferably a membrane that is fluid impregnable. Thecover member102 holds one ormore wipes110 and thebase member104 holds a cleaning agent or fluid120 (FIG. 5). Thecontainer100 preferably incorporates one ormore puncture members130A and130B to split thepartition106 open (preferably along a line) when desired, thereby allowing the cleaning agent orfluid120 to combine with thewipes110. The opening of thepartition106 does not create any particles that might enter thefluid120 orwipes110 or otherwise contaminate thefluid120 and/orwipes110. Thecover102 andbase104 can be formed of a polypropylene (PP) or high density polyethylene (PE) material, or other suitable materials.
Thecover member102 with one or more sides and a top, defines a cavity140 (FIG. 5), sized to hold the one ormore wipes110. Thewipes110 may be any conventional wipe suitable for cleaning surfaces, such as a cloth, polyester, nylon, or the like fabric. Thewipes110 may be dry, or treated with standard wipe chemicals, or presaturated with water to dilute thefluid120 once mixed, or treated with chemicals to be mixed or combined with thefluid120. Aflange142 is provided around the perimeter of thecover member102 for sealing to thebase member104 and extends outward. One ormore tabs144 extend from at least one side of theperimeter flange142, as seen inFIGS. 1 and 2. The cover member is preferably provided with a dispensing slot or opening146 for retrieval and dispensing of thewipes110. Anadhesive cover sheet148 is provided over the dispensingslot146, which can be peeled off to dispense thewipes110. Thesheet148 seals to the top surface of thecover member102 about the dispensing slot oropening146.
Thebase member104 has one or more sides and a bottom, and includes a reservoir150 (FIGS. 3 and 5), for holding the cleaningfluid120. The cleaningfluid120 may be any cleaning agent or solution that is suitable for cleaning contaminants, particularly contaminants found in a clean room. For example, the cleaningfluid120 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 thecover member102, thebase member104 includes aperimeter flange152 with one ormore tabs154 extending from a side thereof.
The one ormore puncture members130A and130B are located on thebase member104 preferably between thereservoir150 and theperimeter flange152. As best seen inFIGS. 4 and 5, thepuncture members130A and130B are respectively positioned near each end of the container and toward one side and adjacent to thepartition106. Thepuncture members130A and130B are inset with respect to thereservoir150, so users can readily locate the puncture members with their fingers. Eachpuncture member130A and130B is formed of a flexible material, such as plastic, and is shaped similar to a convex dome before activation (FIG. 5). The puncture member130 has a dome portion132 and a puncture portion134 located at center of the dome portion132. The puncture portion134 extends outward from the dome portion132 (upward in embodiment ofFIG. 5). The puncture portion134 can be sharp or rounded. Eachpuncture member130A and130B may be activated by pushing the dome portion132 from the base member side toward the cover member side (upward in embodiment ofFIG. 5). This pushes the puncture portion134 outward. In the ready state (FIG. 5), the dome portion132 is inverted and the puncture portion134 is receded; in the activated state (FIG. 6), the dome portion132 and the puncture portion134 are pushed outward until the puncture portion extends through and pierces thepartition106, as seen inFIG. 6.
Thepartition106 is preferably taut such that thepuncture members130A and130B slice, pierce or split open thepartition106 along the length of thecontainer100 for substantially the entire distance between thepuncture member130A and thesecond puncture member130B, thereby allowing the fluid120 in thereservoir150 to enter thecavity140 and combine with thewipes110 and/or any water that is on thewipes110 or in thecavity140. By having two puncture members, thepartition106 can be split the entire length between them. Thepartition106 material and the puncture members130 do not create any particles of thepartition106 that could contaminate the fluid120 and/or wipes110. The user may push bothpuncture members130A and130B at the same time. A tri-legged slot162 (FIGS. 2 and 4) is be added to each puncture portion134 to facilitate activation and pushing through of the dome portion132 so that puncture portion134 can pop out. Thepartition106 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 cleaningfluid120.
In one embodiment, the wipes can be treated with sodium thiosulfate and the cleaningfluid120 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 cleaningfluid120 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 thecontainer100, thewipes110 are loaded into thecavity140 of thecover member102. Thecover member102,partition106, andbase member104 are then sealed together at the perimeter thereof such that theperimeter flanges142 and152 and the perimeter of thepartition106 are sealed together and thecorresponding tabs144 and154. Any sealing method may be used, such as heat sealing. The sealing step separates thereservoir150 and the cavity140 (by the partition106), and extends the shelf life of the wipes and fluid. Thepartition106 completely seals thecavity140 from thereservoir150 so that the wipe110 (dry or presaturated) and the cleaningfluid120 cannot mix and the cleaningfluid120 cannot enter thecavity140. The seal also defines an inside and outside of thecontainer100. Thecavity140,reservoir150, wipes110, fluid120 (when filled), and preferably the puncture member130, are located inside the container100 (and perimeter seal). Theports170 allow fluid to be introduced into (and air or fluid to be removed from, as needed) thecavity140 and/orreservoir150 from outside thecontainer100. In a preferred embodiment, theflange142, theflange152, and thepartition106 are aligned and sealed together simultaneously. The container is then sterilized by any known method, such as irradiation.
Following irradiation, the cleaningfluid120 can then loaded into thecontainer100 through one ormore fill ports170 provided in the seal of thecontainer100, preferably at thetabs144 and154. Theports170 may be formed by channels in the tabs. Eachport170 is an opening that extends the entire length oftab144 andtabs154 to allow fluid to be intruded into thecavity140 andreservoir150 from the outside. Thus, theports170 extend from inside the perimeter seal to outside the perimeter seal. In an alternative embodiment, theports170 can be separate tubes that are placed in the tab channels and extend into thecavity140 andreservoir150. Theports170 enable a fluid to be introduced into thecavity140 and/or reservoir150 (which are inside the perimeter seal and the container) from an external source located outside the perimeter seal and container. The cleaningfluid120 is preferably aseptically filled into thereservoir150 through theports170. 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 fluid120 is filled intoreservoir150. The container can be filled through one of theports170 and vented through another.
Once thereservoir150 is filled with the precise amount of cleaningfluid120 for thewipes110, thefill ports170 are closed and sealed. If thewipes110 are to be saturated with water or if water (or other diluents or chemicals) are to be placed into thecavity140 with thewipes110, that can be done at the same time or before/after the fluid120 is filled into thereservoir150 through one of theports170. For instance, oneport170 can lead into thecavity140 and oneport170 can lead into thereservoir150; or, theports170 can each lead to thecavity140 andreservoir150, separated by thepartition106. Or, the water can be placed into thecavity140 at the same time thewipes110 are loaded into thecavity140.
In one embodiment, a closure valve or connector can be placed at the end of theports170 to operate as a closure. In this manner, the connectors can be opened and closed to open/close theports170. Thecavity140 andreservoir150 can be filled before or after irradiation. Theports170 can be closed at all times, except when being used to fill thecavity140 andreservoir150. The two halves can be formed, then tubularports170 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 thecavity140 andreservoir150 simultaneously or sequentially, either before or after irradiation. Once the fluid is filled into thecavity140 and reservoir, the connector can be closed or removed and theport170 sealed closed. Any suitable connector can be utilized, such as the SPS 4 offered by IPN.
Thecontainer100 can be sterilized either before or after the fluid120 is loaded. If the cleaningfluid120 can be irradiated, then the fluid120 is loaded, heat sealed and irradiated. If the cleaningfluid120 cannot be irradiated, then thecontainer100 is irradiated and then aseptically filled following irradiation.
In operation, the assembledcontainer100 is ready for use. Thecontainer100 can be double-bagged in polypropylene bags and heat sealed so that they can be introduced into a controlled environment. Thepuncture members130A and130B are in the ready state. To use thecontainer100 and thewipes110, the puncture members130 are activated by the user pushing them from outside thebase member104 through thepartition106 to allow thewipes110 to be saturated by the cleaningfluid120. It is preferable that thewipes110 and the fluid120 sit for a period of time, such as five minutes, to allow the cleaningfluid120 to completely saturate the wipes110 (and mix with any water in the cavity) without dry spots on the wipes. Once saturated with the fluid120, thewipes110 are ready for use and may be dispensed through theopening146 in thecover member102 after removing theadhesive sheet148. The container is safe to bring into or have in a clean room. Thecontainer100 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. Thecontainer200 ofFIGS. 7A and 7B is similar to thecontainer100, except that thecontainer200 holds only a single wipe. Like the first embodiment, thecontainer200 includes acover member202 with adispensing opening246 for the wipes and abase member204 with areservoir250 for the cleaning fluid. Thebase member204 includes one ormore puncture members230 similar to thepuncture members106 of the first embodiment for slicing open a partition between the cover and thebase members202 and204. One or morefluid ports270A and270B may be provided in the perimeter seal of thecontainer200 like thecontainer100 of the first embodiment. Once theport270A communicates with and allows first fluid (such as water) to be filled into the cover cavity andother port270B 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 cleaningfluid120 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 aport170 is shown and described as leading into each of thecavity140 and thereservoir150, one or bothports170 need not be provided. For instance, a fluid120 can be filled in thecavity140 and/or thereservoir150 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 thebase member104, 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.