The present invention relates to the transportation of fluids, and more particularly to a rigid outer container for aseptic storage and/or transport of pharmaceutical fluids.
In the pharmaceutical industry, various types of fluids are used for the preparation, testing, and storage of pharmaceutical compositions, including drugs, drug components, cleaning solutions, and other fluids. These fluids often need to be safely transported between locations. Additionally, it is often important to maintain the sterility of these fluids before, during, and after transport. Due to sterility requirements, shipping containers for these fluids are often accompanied by various connectors, tubes, and filters that enable aseptic processing of the fluid.
Existing systems for transporting such fluids include a flexible inner container which holds the fluid (referred to as a biocontainer), such as a flexible bag, and an outer rigid container that supports and protects the biocontainer. The biocontainer is connected to tubing for filling, draining, and accessing the fluid. Other equipment may be connected to the biocontainer and the tubing, such as filters, pumps, and connectors that enable aseptic processing of the fluid. The tubing and connectors maintain a sterile fluid path for fluid access and enable sterile connections even in a non-sterile environment.
The tubing, connectors, filters, pumps, and other ancillary equipment are often shipped with the biocontainer for use in draining or accessing the fluid when it reaches its destination. Once the biocontainer is drained, the entire assembly may be shipped back to the initial location for re-use.
Therefore, there is a need to provide an outer container that can support the filled biocontainer as well as the ancillary equipment that enables aseptic processing of the fluid. There is also a need for a container that has compact outer dimensions and that minimizes the space occupied by the empty container during return shipping.
The present invention relates to the transportation of fluids, and more particularly to a rigid outer container for aseptic transport of pharmaceutical fluids. In one embodiment, the container includes a base, a perimeter wall, and a lid, enclosing a main cavity. Additionally, an inner wall is provided within the cavity, dividing the cavity into first and second compartments. The biocontainer that carries the fluid is located in the second compartment, behind the inner wall. The first compartment on the opposite side of the inner wall provides access and storage space for ancillary equipment that accompanies the biocontainer—such as connectors, tubing, and filters that enable aseptic processing of the fluid inside the biocontainer. This equipment may be stored in the first compartment, and can be connected to the biocontainer through openings in the inner wall. In one embodiment, the inner wall can be folded into a storage position when the container is not in use, to minimize the space occupied by the empty container during return shipping. In particular, the perimeter walls can be folded toward the base, and stowed between the base and the lid for shipment. The walls can also be removed for service or replacement. In one embodiment, the inner wall is pivotably attached to the front wall to facilitate the movement of the inner wall and front wall into the collapsed, stowed position. In this stowed position, the biocontainer is compact and occupies less space than a deployed container for return shipping. After return shipping, the container can be reassembled for shipment of a new filled biocontainer, with the inner wall deployed to create the separate compartments and provide easy access to both the biocontainer and the ancillary equipment.
In one embodiment, a system for aseptic storage or transportation of a fluid includes a rigid outer container for transport of a fluid in a biocontainer. The rigid outer container includes a front wall, a back wall, and a main cavity inside the outer container. An inner wall is provided to divide the main cavity into two compartments. The first compartment is located between the front wall and the inner wall, and the second compartment is located between the inner wall and the back wall. The rigid outer container may be used to transport a filled biocontainer in the second compartment.
In one embodiment, a container for aseptic storage or transportation of a fluid is provided. The container includes a base and a perimeter wall connected to the base. A lid is attachable to the perimeter wall. The base includes a floor, and the floor, the perimeter wall, and the lid define a cavity. An inner wall is provided to divide the cavity into two compartments. The inner wall extends upright, such that each compartment extends between the floor and the lid. A biocontainer may be supported in the second compartment, behind the first compartment.
In one embodiment, a method for aseptic storage or transportation of a fluid is provided. The method includes providing a rigid outer container, which has a base and a perimeter wall. The base and perimeter wall define a cavity. The method also includes dividing the cavity into first and second compartments. The first compartment is located between the second compartment and the front end of the container. The method also includes supporting a biocontainer in the second compartment, and storing ancillary equipment for the biocontainer in the first compartment. According to particular end-use needs, the method may also include filling the biocontainer with a fluid, and accessing the biocontainer through the first compartment.
The present invention relates to the transportation of fluids, and more particularly to a rigid outer container for aseptic transport of pharmaceutical fluids. In one embodiment, the container includes a base, a perimeter wall, and a lid, enclosing a main cavity. Additionally, an inner wall is provided within the cavity, dividing the cavity into first and second compartments. The biocontainer that carries the fluid is located in the second compartment, behind the inner wall. The first compartment on the opposite side of the inner wall provides access and storage space for ancillary equipment that accompanies the biocontainer—such as connectors, tubing, and filters that enable aseptic processing of the fluid inside the biocontainer. This equipment may be stored in the first compartment, and can be connected to the biocontainer through openings in the inner wall. In one embodiment, the inner wall can be folded into a storage position when the container is not in use, to minimize the space occupied by the empty container during return shipping. In particular, the perimeter walls can be folded toward the base, and stowed between the base and the lid for shipment. In one embodiment, the inner wall is pivotably attached to the front wall to facilitate the movement of the inner wall and front wall into the collapsed, stowed position. In this stowed position, the biocontainer is compact and occupies less space than a deployed container for return shipping. After return shipping, the container can be redeployed for shipment of a new filled biocontainer, with the inner wall deployed to create the separate compartments and provide easy access to both the biocontainer and the ancillary equipment.
It should be noted that the terms front, back, top, bottom, side, and other similar terms are relative terms only, used for convenience to describe relative locations of components, and are not intended to be limiting in an absolute sense.
A container 10 for aseptic storage and/or transport of a fluid, according to an embodiment, is shown in
In the stowed position shown in
In one embodiment, the container 10 includes an inner wall or partition 30 inside the main cavity 28, when the container is in the deployed position. A top view of the container with the inner wall 30 deployed is shown in
In one embodiment, the second compartment is larger than the first compartment, and is designed to carry and support the biocontainer filled with the fluid. An empty biocontainer 36 is shown in
The first compartment 32 provides available space for ancillary equipment that is shipped with the biocontainer and facilitates access to the biocontainer for filling, draining, sampling, or other activities. Tubing that connects to the biocontainer 36 can be passed through one or more openings 38A, 38B in the inner wall 30 and into this first compartment 32, where the tubing can be more easily accessed, organized, and stored. In one embodiment, the inner wall 30 includes a first opening 38A near the floor 18 of the container, and a second opening 38B near the lid (also shown in
A drain 40 may be provided in the base 14, as shown in
As shown in
Due to the side-by-side arrangement of the compartments, the first compartment provides access to the biocontainer at both the top and the bottom of the biocontainer. As shown in
Passing the tubing through the inner wall 30 and into the first compartment 32 not only keeps the tubing organized and easy to access, but also protects the biocontainer 36, as the tubing is not routed along the inside walls of the second compartment 34. If the tubing is routed between the biocontainer and the walls of the container, the tubing can press against the biocontainer, which can create a risk of puncturing or snagging the biocontainer, or tangling or collapsing the tubing.
The collapsible design of the container 10 and the method for deploying or collapsing the container is shown in
As shown in
In
The front and back walls 20, 22 have locking features such as latches 64 that engage the side walls 24, 26 when the walls are in the upright position. In one embodiment, the latches resemble door latches, with an extension from the front and back walls 20, 22 entering a corresponding recess in the side walls 24, 26. The latches 64 can be operated, such as slid inward, to release the front and back walls 20, 22 from the side walls and enable the walls to fold down.
The front wall 20 and inner wall 30 are the last components deployed, and the first stored, at the bottom of the stack of walls.
In one embodiment, the inner wall 30 is connected to the front wall 20 by a pivot joint 52, which enables the inner wall to pivot with respect to the front wall for storage. In the embodiment shown, two pivot joints 52 are provided between the inner wall 30 and the front wall 20 (see
Once the inner wall 30 is rotated into this deployed position (
The pivot arms 54 are sized to be the appropriate length to pivot the inner wall 30 forward so that the latches 56 clear the top of the front wall 20 in the stowed position, as shown in
The length of the latches 56 can be selected according to the desired size of the first compartment 32. In one embodiment, the distance between the inner wall 30 and the front wall 20 is about 3.25 inches. This dimension is chosen to provide the desired storage volume in the first compartment 32. In one embodiment, stop blocks 60 are provided on the floor 18 of the base 14 to abut the inner wall 30 in its deployed position (see
In one embodiment, the inner wall 30 is formed from a plastic panel 30a and a reinforcing metal plate 30b, as shown in
The metal plate 30b is attached to the plastic panel 30a on the surface of the panel facing the front wall 20, facing into the first compartment 32. The metal plate 30b reinforces the inner wall and provides a mounting surface for attachment of the latches 56 and pivot joints 52. In one embodiment, the metal plate is a stainless steel material, and it may have a mirrored finish. A mirrored metal plate may also be attached to the inside surface of the front wall 20, so that the two mirrored plates face each other, providing additional light in the first compartment 32. In one embodiment, the metal plate attached to the inner wall is about 0.050 inches in thickness, and the plastic panel is about ⅜ inch thick. The dimensions are chosen such that the inner wall 30 is thick enough to have the strength to withstand pressure from a filled biocontainer in the second compartment, but also thin enough to fold down and lay flat under the front wall 20 for storage.
To collapse the container 30 into its compact, stowed configuration (shown in
In one embodiment, a method for aseptic storage or transport of a fluid includes providing a rigid outer container such as the container 10. The container has a base and a perimeter wall defining a cavity, and has a front end with a drain. The method includes dividing the cavity into first and second compartments, the first compartment being between the second compartment and the front end of the container. The method also includes supporting a biocontainer in the second compartment, and placing ancillary equipment for the biocontainer in the first compartment. Examples of the ancillary equipment include tubing, connectors, filters, pumps, ports, plugs, and other equipment used to access, sample, drain, or fill the biocontainer. The method may also include filling the biocontainer with a fluid. The method may also include accessing the biocontainer from the first compartment, such as via tubing, connectors, or other mechanisms that pass into or through the first compartment to the biocontainer. In one example, access to the biocontainer is provided by tubing that passes from a port in the biocontainer through an opening in the inner wall, through the first compartment, and out the drain.
In one embodiment, an inner wall or partition is provided to divide the cavity into the first and second compartments. The inner wall is connected to the perimeter wall. For example, the inner wall may be pivoted from a stowed position into a deployed position and then latched to the perimeter wall.
In one embodiment, the interior dimensions of the cavity 28 are about 102×72 cm (40×28 inches), which is sized for a 500 L biocontainer. In other embodiments, the container 10 is sized for a biocontainer with a total volume of 100 L, 250 L, 1,000 L, or 2,000 L. In general the range of volumes of the biocontainer may be between about 100 L to about 2,000 L. In one embodiment, the volume of the biocontainer is about 500 L, or about 1,000 L, or between about 500-1,000 L. The containers for these volumes have approximately the same aspect ratios as the 500 L container. In one embodiment, the biocontainer 36 is dimensioned to fit inside the second compartment 34, extending between the side walls 24, 26 and between the inner wall 30 and the back wall 22. The biocontainer may also be provided with ports at the top and/or bottom that are aligned with the openings 38A, 38B in the inner wall 30 for easy access.
In one embodiment, the container 10 is made from a suitable rigid plastic material, such as ABS (acrylonitrile butadiene styrene) polystyrene, glass-filled nylon, or polypropylene. The container 10 may be sanitized prior to use and between uses.
Although the present invention has been described and illustrated in respect to exemplary embodiments, it is to be understood that it is not to be so limited, since changes and modifications may be made therein which are within the full intended scope of this invention as hereinafter claimed.
This Patent Application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/454,808, filed on Mar. 21, 2011, the entire contents of which are hereby expressly incorporated by reference.
Number | Name | Date | Kind |
---|---|---|---|
3123254 | Rabby et al. | Mar 1964 | A |
3137415 | Faunce | Jun 1964 | A |
3212681 | Weikert | Oct 1965 | A |
4964528 | Wagoner | Oct 1990 | A |
5085349 | Fawcett | Feb 1992 | A |
5323911 | Johnston et al. | Jun 1994 | A |
5402915 | Hogan | Apr 1995 | A |
5419448 | Watson | May 1995 | A |
5622276 | Simmons | Apr 1997 | A |
5826752 | Latimer | Oct 1998 | A |
6520364 | Spykerman et al. | Feb 2003 | B2 |
6533122 | Plunkett | Mar 2003 | B1 |
6543495 | Hougland | Apr 2003 | B2 |
6955273 | Hartwall | Oct 2005 | B2 |
7210594 | Schutz | May 2007 | B2 |
20070145051 | Uffner et al. | Jun 2007 | A1 |
20080029517 | Briers | Feb 2008 | A1 |
Number | Date | Country | |
---|---|---|---|
20120241447 A1 | Sep 2012 | US |
Number | Date | Country | |
---|---|---|---|
61454808 | Mar 2011 | US |