Patent Application
20130206616
The present application is related to storage containers, and more particularly, storage containers for the storage of fluids within a cleanroom. The storage container comprises easy clean surfaces, an internal access point for the storage of pipework and hoses, and a forkliftable bottom pallet.
Boxes and storage containers for use in a cleanroom have previously been constructed of stainless steel, plastic, and other materials. However, the stainless steel and some plastic designs can be difficult to clean making sterilization of the containers difficult, if not impossible. Furthermore, these containers are often heavy, making movement of the containers difficult within the cleanroom environment.
Many containers used in cleanroom environments, being made of stainless steel, are also expensive to manufacture and are relatively inflexible with regard to modifications of the stainless steel product. The invention disclosed here is adaptable to modifications of particular customers and is easy to be sterilized.
Objects of the invention, e.g. it is an object of the present invention to provide a new and improved cleanroom box which is easy to sterilize, easy to modify, easy to move within the cleanroom, provides easy access to pipework, and provides easy storage and transportation of fluids within a cleanroom environment.
In accordance with the invention, these and other objects are attained by providing a cleanroom box comprising a donor box comprising four sides and a base, where there is at least one hole in the base of the box; the cleanroom box further comprising at least one pallet base attached to the base of the donor box and where the donor box and the pallet base provide for two openings, the first directly below the donor box, and the second opening below the top of the pallet base, and where the cleanroom box can be sterilized.
According to another aspect of the invention, a cleanroom box capable of storing sterile liquids is provided which comprises a donor box comprising four sides, a base, and a hole in the base, an upper and lower pallet base, each of which have four sides a top and a bottom, a first easy clean plate of substantially the same length and width as the upper and lower pallet bases being attached to the bottom of the donor box, and a second easy clean plate being attached between the upper and lower pallet boxes, and where the donor box is connected to the combined upper and lower pallet base, and where all products are capable of being sterilized.
According to another aspect of the invention, a cleanroom box for sterile liquids is provided comprising a donor box with four sides, a base, at least four legs, and open top, and at least one hole in the base of the box, a pallet base of substantially the same length and width as the donor box comprising four sides, a flat top, a base, and support legs below the base, an easy clean plate secured to the top of the pallet base, and wherein the donor box includes legs secured to the top of the pallet base, the seams being secured by plastic welding, and wherein said box being capable of being sterilized.
According to still another aspect of the invention, a method of manufacturing a cleanroom box comprises the steps of securing a donor box to an easy clean plate, securing said donor box and easy clean plate to an upper pallet base, welding the seams with plastic to secure the donor box, easy clean plate, and pallet base, cutting a hole in the donor box base, and securing a pipe within the hole cut in the donor box base.
A more complete appreciation of the present invention and many of the attendant advantages thereof will be more fully understood by reference and to the following descriptions in connection with the accompanying drawings
The embodiments of the invention and the various features and advantages thereto are more fully explained with references to the non-limiting embodiments and examples that are described and illustrated in the accompanying drawings and set forth in the following descriptions of those drawings. The figures in the accompanying drawings are not necessarily drawn to scale and the features of one embodiment may be employed with the other embodiments as the skilled artisan recognizes, even if not explicitly stated herein. Descriptions of well-known components and techniques may be omitted to avoid obscuring the invention. The examples used herein are intended merely to facilitate an understanding of ways in which the invention may be practiced and to further enable those skilled in the art to practice the invention. Accordingly, the examples and embodiments set forth herein should not be construed as limiting the scope of the invention, which is defined by the appended claims.
As used herein, terms such as “a,” “an,” and “the” include singular and plural referents unless the context clearly demands otherwise.
The term “cleanroom” refers to a location within a facility in which biopharmaceutical liquids are either produced or used under sterile conditions. Various levels of cleanliness may be achieved, and the cleanroom denotes a stringent sterility requirement as used in the production and handling of biopharmaceutical products. Typically, the requirements are based on FDA sterilization requirements or typical Grade A, B, C, or D air classification systems for manufacture of sterile products, having a maximum number of particles or micro-organisms per m3.
The term “easy clean surface” as used herein is to mean a surface that is low porous or non-porous, relatively smooth to the touch, has plastic welded seams, contains few, if any, sharp (e.g. 90 degree) corners, and is capable of being sterilized for use in a cleanroom. Further, an easy clean surface should be free of spaces where foreign materials or moisture could be easily trapped. Such easy clean surfaces are present on all external surfaces, i.e. those open to the air. The easy clean surface, by having smooth surfaces and no seams or areas to trap moisture and other materials, can be thoroughly and easily cleaned for use in a cleanroom environment. The materials for these easy clean surfaces include plastic or plastic polymer materials, carbon fiber and metallic materials. The surface of these materials, which are open to the air, are non-porous, smooth to the touch and can be cleaned or sterilized without breaking down.
The term “donor box” as used herein is a box that is capable of being attached to a donor pallet and which can incorporate removable sides and provides an area for the storage of sterile materials. Such donor box will typically be made of a plastic or plastic polymer material, but may incorporate or be wholly made of other materials, so as to increase strength and rigidity. Such materials may include other plastic materials, carbon fibers, metals, and other suitable materials known to one of skill in the art. The donor box may further comprise supporting structures within the walls and floor of the box. The support structures may comprise vertical and horizontal support ribs and cross ribs within the walls and floor so as to provide rigidity and strength. Walls may contain no, a few, or numerous support structures, or may include a honeycomb like structure throughout the wall or floor section so as to provide additional strength or rigidity where necessary.
The term “pallet base” as used herein means a pallet capable of supporting a product placed on, or attached to the pallet base, and is configured to accept the fork of a forklift for the movement and transportation of goods attached to or sitting on the pallet. The pallet is typically made of a plastic or plastic polymer material, such as a high density polyethylene, but may also comprise carbon fiber, metal, and other materials known in the art. The pallet base is one of any number of various pallet designs and may include any number of support legs and or cross supports between the legs. Typical pallet bases to be used include hygiene pallets, a class of pallets that comprise few, if any, cracks or crevices that harbor bacteria and prevent sterilization.
The term “easy clean plate” means a plastic, plastic polymer, carbon fiber, or metal plate where at least one side of the easy clean plate has an easy clean surface, such that the easy clean plate can be attached to a structure allowing the structure to be easily sterilized. Essentially, the easy clean plate becomes a façade on the surface of another structure, and allows the structure to remain in place, but have a new façade that is easily cleanable for entry into a cleanroom. Examples of easy clean plates are shown in
The term “plastic welding” as used herein means any process of joining two or more plastic materials together, often through the use of a plastic filler. Plastic welding is commonly utilized to fill a seam or corner, or bonding the plastic together to form a seal between two or more pieces of plastic. Such welding techniques include but are not limited to hot gas welding, speed tip welding, extrusion welding, solvent welding and other forms of plastic welding techniques known in the art. The appropriate plastic to use, filler materials, and method for welding will be obvious to one of ordinary skill in the art.
The terms “about” and “substantially” are interchangeable and mean within 10% of a stated length. For example, a length of about 1000 mm includes lengths of 900 mm to lengths of 1100 mm and all lengths in between.
The terms “tubing” or “pipework” are used interchangeably, and refer to flexible or inflexible tubing that allow for fluids to flow through said tubing.
Cleanroom environments allow materials to be combined, such as chemical precursors and biological materials, such that the cleanroom prevents the introduction of foreign material. Cleanroom environments have strict controls to prevent the introduction of foreign materials that could damage or destroy the sterile materials within that cleanroom. Storage containers for use in such environments therefore themselves need to be able to be sufficiently sterilized that they can be introduced into the cleanroom. Small containers are easy to sterilize as they likely do not need to carry substantial weight and so can be lightweight and made of easily cleaned materials. Large containers for the storage and transportation of 250 L to 1000 L or more of fluids require the use of heavier materials and materials with substantial support built into the materials to handle the additional weight. These large containers are difficult to completely sterilize and absent such sterilization, they cannot enter the cleanroom environment.
Such mechanisms to sterilize include any number of known methods, including increased temperature, pressure, steam, UV or other light inactivation, or use of solvents, detergents and other materials to clean and/or disinfect the clean room box. Autoclaving or other similar process is one such mechanism, that can be used alone or in conjunction with other processes to ensure that sufficient cleanliness is met.
Suitable sterility conditions depend on the particular clean room environment, but are intended to meet FDA Sterility Assurance Level of <10−6 or about <10−3 or about, 10−2 or other appropriate measurement. Other appropriate measurements utilize maximum number of particle permitted per m3 with a size of 0.5-5 μm from 3,500,000, about 350,000, about 3,500, and less than 3,500, and having particles of >5 μm less than 20,000, less than 2,000, and less than 5, and 1 or fewer. Similarly, a measure of maximum number of viable micro-organisms per m3 may be utilized, where in a room or surface has less than 500, less than 100, less than 5 and less than 1 viable micro-organisms per m3.
Referring to
The cleanroom box 15 is made from a substantially inflexible material, such as any number of plastic or plastic polymers known to one of ordinary skill in the art, carbon fiber, and metal materials. The cleanroom box 15 additionally comprises supporting structures within the walls and bases of the donor box 1, and pallet bases in the various embodiments. Thus, the walls and bases of the donor box 1, and the pallet bases are substantially hollow, or contain rib supports. The use of ribs or cross ribs within the structure of the walls allows there to be substantial strength and rigidity without significant additional weight. An example of a supporting rib 23 can be seen in
It is understood that the cleanroom box 15 may be made of different materials and that the cleanroom box 15 may comprise numerous parts, each made of different materials.
Some materials have porous surfaces or sharp corners, and are therefore typically not suitable for use on exterior surfaces of the invention. Non-porous, smooth materials are suitable for exterior surfaces in the invention. However, even such non-porous materials may provide space for collecting dust or harboring moisture or bacteria. Plastic welding joints, small gaps, cracks, and covering open spaces eliminate areas prone to harboring undesirable material. Accordingly, the purpose of the easy clean surface is that the surface is smooth, non-porous, and allows for quick and easy sterilization.
As shown in
The pallet bases may be any size pallet base that includes an opening for use with a forklift. The pallet base may be as small as 600 mm on a length or width. There is no current maximum length for a pallet base, so long as it comprises an opening for use with a forklift. Typical sizes used in manufacturing the materials include pallets that are about 600 mm by about 600 mm, about 800 mm by about 800 mm, about 1000 mm by about 1000 mm, about 1100 mm by about 1100 mm, and about 1200 mm by about 1200 mm. Pallet sizes may also be rectangular in shape, and be about 600 mm by about 800 mm, about 600 mm by about 1000 mm, about 600 mm by about 1200 mm, about 800 mm by about 1000 mm, about 800 mm by about 1200 mm, and about 1000 mm by about 1200 mm, or any lengths in between.
The upper pallet base 2 and lower pallet base 3 comprises 6 support posts, but it is understood that any number of supporting posts may make up the invention. Accordingly, the invention is not confined to a pallet base that comprises four, six, or nine support posts, which are typical. Any number of support posts may be utilized, so long as the pallet can support a load placed upon it and has a forkliftable opening. The upper pallet base 2 comprises upper supports 19. The lower pallet base 3 comprises lower supports 20. Additional upper and lower supports 19 and 20 both located on the outside edge of the pallet base and also in the center of the pallet base are acceptable. A pallet base comprises four corner posts, but other configurations without corner posts are also acceptable. The upper and lower pallet bases may comprise four corner posts and additional support posts. Support posts within the center of the pallet bases 2 and 3 are also acceptable. For example, configuration of nine support posts, (three rows of three posts) is one typical scheme that can be used. This allows for there to be eight support posts on the outside edge of the pallet bases and a single support post in the middle of the pallet bases. The nine spaces for these support posts can be seen in
The donor box bottom plate 6 is one example of an easy clean plate that is secured to a feature on the invention that requires sealing off of spaces that may prevent sterilization. Examples of this easy clean plate are shown in
The donor box hole 5 is typically from 20-200 mm in diameter, but can range from 1 mm to 500 mm. The donor box hole 5 can be from about 10-250 mm, or about 25-200 mm, or about 30-150 mm or about 50-150 mm, or about 60-130, or about 75-125 mm, or about 80-100 mm. Holes may be larger or smaller for particular tubing, and if there is more than one donor box hole 5, the holes can be of different diameters within the same cleanroom box 15. Example diameters of 80 and 100 mm are shown in
When drilled, the donor box hole 5 creates open areas within the donor box bottom 26. To seal off this opening, yet still allow the passage of materials through the donor box bottom 26, the donor box hole must be sealed. Accordingly, a donor box pipe 8, is positioned within the donor box hole 5 to seal the outer circumference of the donor box hole 5. Absent the donor box pipe 8, the cleanroom box 15 would be difficult to sterilize.
The donor box pipe 8 fits within the donor box hole 5. Specifically, the donor box pipe's 8 outside diameter is the same or slightly smaller than the diameter of the donor box hole 5, thus securely fitting within the donor box hole with or without adhesive. All seams between the donor box pipe 8, the donor box hole 5, the donor box bottom 26, and the donor box bottom plate 6 will be secured with plastic welding. The donor box pipe 8 seals any openings in the donor box bottom, maintaining easy clean surfaces.
The donor box hole 5 provides access from one side of the donor box 1, through the donor box bottom 26 and into the space below, which is the pipework opening 17. This hole allows for the transfer of sterile liquids from the donor box without the need to open the removable box sides 4, or to otherwise open the cleanroom box 15.
Accordingly, the pipework opening 17 is the open space between the donor box bottom 26 and the upper pallet top 29 in
The attachment of each of the donor box bottom plate 6 and lower pallet base shelf 7 is accomplished via bolts 9 and nuts 10, or alternatively can be secured by other means known in the art, such as nails, staples, various glues and adhesives, and/or plastic welded. The parts may also be chemically fused together. However, whatever means that are used, plastic welding is used to fill and secure each seam.
After the attachment of the lower pallet base 3 to the lower pallet base shelf 7, the combined piece is attached to the upper pallet bottom 30. The pieces are secured together by various means known in the art, including by nut and bolt, nails, staples, various glues and adhesives, and/or plastic welded. However, whatever means that are used, plastic welding is used to fill and secure each seam.
After all the articles are secured together, each seam created by the various attachments is filled by plastic welding. The purpose of filling each seam is to eliminate space or seams that would prevent sterilization of the cleanroom box. After each seam is plastic welded, the seams are cleaned, sanded, and polished as necessary. This results in smooth seams resulting in the easy clean surface. Joints that form about a 90 degree angle are also filled with plastic welding and polished in the same manner. Again, this prevents such joints from holding moisture of other undesirable materials.
After securing all the pieces together plastic welding is required at every seam.
Cleaning of the donor box for entry into a clean or sterile room can be completed by various means known to one skilled in the art. Different levels of cleanliness and/or sterilization are required for different products, and will be known to one of ordinary skill in the art. The cleanroom box 15 is designed to allow for entry into the strictest cleanroom environments.
Storage of fluids in the donor box 1 typically includes the addition of a plastic bag or stainless steel insert or receptacle within the donor box 1. This plastic bag or metal receptacle actually holds the sterile liquids within the cleanroom box 15. Such a storage container fits within the confines of the donor box 1, and the removable box sides 4. The plastic bag or metal receptacle comprises tubing or pipework for the transfer of the sterile liquids. One end of the tubing is attached to the plastic bag or metal receptacle and the other end is stored in the pipework opening to allow for transfer of materials in and out of the bag or receptacle. These tubes and pipework are run through the donor box hole 5, and the tubing and pipework is stored in the pipework opening 17. Use of pipework in this manner allows for quick and easy transfer of materials from one container to another.
The embodiment shown in
With the embodiment of
Once the footed donor box 21 is attached to the table donor pallet base 22, and the table pallet shelf 16, a plastic weld is provided around all seams created by attaching each of the pieces together. The seams and joints are plastic welded and all welds are cleaned, sanded, and polished to make easy clean surfaces.
The shelf pipe hole 14 is aligned with the donor box hole 5, either as the hole is cut after securing the donor box bottom plate 6, or the shelf pipe hole 14 is cut to match the location of the donor box hole 5. A donor box pipe 8 will be secured within the donor box hole 5 by plastic welding. Seams and edges around the donor box hole 5 will also be plastic welded as necessary. The shelf pipe hole 14 is provided to allow for the passage of piping or other materials between the donor box 1 and into the pipework opening 17.
In certain embodiments the cleanroom box is made by first welding the donor box 1 to the donor box bottom plate 6, and sealing off any spaces or openings in the bottom of the donor box 1. Then the donor box 1, being sealed, is welded to the upper pallet base 2. The parts are welded together with 7 mm triangular weld wire for internal welds and exterior welds are done through extrusion plastic welding. After welding, the donor box hole 5 is cut into the donor box bottom 26 and the donor box bottom plate 6 at the appropriate location and diameter as needed. A donor box pipe 8 is then plastic welded into the donor box hole 5 securing all seams between the door box pipe 8, the donor box bottom plate 6, and the donor box bottom 26. Then the lower pallet base 3 is attached to the lower pallet base shelf using bolts 9 and nuts 10 or through plastic welding the pieces together. The lower pallet base 3 and lower pallet base shelf 7 are then plastic welded to the bottom of the upper pallet base through plastic welding, using 7 mm triangular weld wire for internal welds and extrusion welding of exterior welds. All seams created in the production of the cleanroom box 15 are further plastic welded to fill in any spaces created by securing various parts together. Finally, all welds are cleaned, sanded, and all external welds are flamed and/or polished.
Through this construction, all areas that could potentially harbor moisture or prevent sterilization are enclosed and the resulting surfaces are all easy clean surfaces. Further, the use of the easy clean plates shown in
As illustrated in
Further embodiments may be made by securing a donor box 1 to an upper pallet base 2, and securing a lower pallet base 3 to the bottom of the upper pallet base, then drilling a donor box hole 5 into the donor box bottom 26. When necessary, a donor box pipe 8 is then secured into the donor box hole 5, to secure the openings in the donor box bottom 26. Finally, all seams and joints are plastic welded, cleaned, sanded, and flamed to provide for secure and smooth exterior seams and joints. The resulting product is a cleanroom box 15.
Once the cleanroom box 15 is constructed, there may be a requirement to move the cleanroom box both within a cleanroom and outside of a cleanroom. Moving the cleanroom box 15 may be achieved in a number of ways. The clean room box 15 is configured with a forklift opening 18, which allows for the quick and easy movement with a forklift or similar machine. However, the cleanroom box 15 may also be transported on a dolly 12, as shown in
Movement outside a cleanroom can include the use of a forklift. The forklift or other appropriate machine assists in the movement and transportation of the cleanroom box 15. However, once outside a cleanroom environment, the cleanroom box 15 requires re-sterilization before it can again be used for storage of sterile materials in a cleanroom environment.
The invention now being fully described, it will be apparent to one of ordinary skill in the art that many changes and modification can be made thereto without departing from the spirit or scope of the appended claims.
| Number | Date | Country | |
|---|---|---|---|
| 61598148 | Feb 2012 | US |
