Supports: cabinet structure – Barrier opening with flexible seal for operator
Reexamination Certificate
2002-02-19
2003-12-02
Braun, Leslie A. (Department: 3632)
Supports: cabinet structure
Barrier opening with flexible seal for operator
C312S004000, C141S384000, C141S098000
Reexamination Certificate
active
06655759
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to rapid transfer port (RTP) systems for transferring articles between two environments (such as an isolator barrier system and a transfer container) that are adapted to be brought into close proximity to one another by a docking operation. More particularly, the present invention relates to a container assembly for use with an RTP of the type that requires rotation of the device being attached thereto. The container assembly has an enclosure that, during docking, is not required to be rotated.
2. Description of the Related Art
Certain manufacturing processes require the maintenance of separation between two environments to avoid contamination of the cleaner of the two environments by the dirtier of the two. This is accomplished with the use of environments such as isolation barriers. For example, in the case of certain pharmaceutical products, the manufacturing process is performed within these isolation barriers to prevent contamination of the product being produced by dust particles, bacteria and viruses which are found in the outside ambient air. The same holds true for the assembly of certain medical devices. In the case of radioactive operations or bacteriological procedures, the environment within the isolation barrier is dirty as compared to the outside ambient air. In these cases, the isolation barrier serves the function of keeping the product being handled from escaping into the external environment.
In recent years, in the pharmaceutical industry, because of the expense and operational difficulties of maintaining so-called “clean rooms” into which operators enter to carry out procedures, the use of isolation barriers has become common practice. The isolation barriers, in concept large glove boxes, are integrated onto the machinery used to carry out the necessary manufacturing operations. A variation of these isolation barriers is what is commonly known as a RABS, Restricted Access Barrier System.
Means for transferring components, product, supplies, etc. into and out of these isolation barriers without risk of contamination of the components being transferred by the “dirty” external environment during the docking and components transfer process must be provided. To accomplish this, isolator barrier systems and RABS feature devices generally called Rapid Transfer Ports (RTP). These RTP devices may be of various type, size and configuration. A common type of RTP device is one that is offered by the French company La Calhene, referred to as the DPTE. This device requires rotation of the transfer container during the docking process. This type of RTP device is generally mounted on an outer surface of the isolation barrier and features docking attachments for a pre-sterilized transfer container housing the components to be transferred. Upon the docking process, the operator places the transfer container into alignment with the RTP and rotates the container approximately 60 degrees to complete the docking operation. The docking process firmly attaches the transfer container to the RTP and, simultaneously, the transfer container door to the RTP door. Once docked, the operator reaches inside the isolation barrier via gloves located on the isolation barrier wall and opens the RTP door, with it attached the transfer container door, and gains access to the components located within the transfer container. To prevent contamination of the “clean” environment, the docking process places the “dirty” surfaces of the RTP and of the transfer container in sealed contact with each other thus not permitting “dirty” particles to escape into the “clean” environment.
The rotation necessary to dock the transfer container onto an RTP causes tumbling action of the components which are contained within the transfer container. This tumbling action may be acceptable when transferring soft plastic components such as stoppers or cleaning supplies but it is undesirable, if not prohibitive, when transferring heavy, delicate machine components. In addition, the rotation of the container upon docking does not permit interface of the container to a lifting device such as a hoist or crane. Such lifting operation may be necessary to meet the manufacturing requirements of some products.
SUMMARY
The present invention is a container assembly for use with a rapid transfer port. The rapid transfer port (RTP) is of the type having an RTP door, an RTP circular seal around the door, and spaced RTP indentations. The RTP requires rotation of the device being attached thereto. The container assembly includes a circular ring member having an interface end and a bearing system end. The interface end includes a first set of ring member protrusions for engagement with RTP indentations of an RTP and a container assembly circular seal for providing sealing engagement of the ring member and the RTP. A circular enclosure door is concentrically positioned within the ring member. The enclosure door includes a first set of enclosure door indentations for engaging associated RTP door protrusions and a second set of enclosure door indentations for engaging a second set of ring member protrusions. The container assembly circular seal further provides sealing engagement of the ring member and the enclosure door. A bearing system is engaged with the bearing system end of the ring member. An enclosure having a bearing system engagement portion is engaged with the bearing system wherein the bearing system provides relative rotation of the ring member and the enclosure about a central axis of the ring member. The enclosure further includes an enclosure seal operatively engaged with the ring member for providing a sealing engagement between the enclosure and the ring member. The ring member provides the rotation required for proper attachment of the container assembly to the RTP without any requirement for rotation of the enclosure.
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Braun Leslie A.
Ginsberg Lawrence N.
Morrison Naschica S.
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