Fluent material handling – with receiver or receiver coacting mea – Filling means with receiver or receiver coacting means – With receiver and supply securing means
Reexamination Certificate
1999-09-03
2001-02-27
Maust, Timothy L. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Filling means with receiver or receiver coacting means
With receiver and supply securing means
C141S069000, C141S085000, C141S094000, C141S329000, C141S348000, C141S349000, C141S350000, C141S360000, C141S386000, C215S215000, C215S250000, C215S253000, C215S255000, C220S284000
Reexamination Certificate
active
06192948
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a closure for a container used in the transfer of materials or components between a contained isolation or clean-room process area and a non-sterile outside environment.
Transfers of sterilised materials between sterile or clean areas via the outside environment are routinely made in industries such as the pharmaceuticals, medical devices, biotechnology and food industries. Typically, a container or bag, the interior of which is sterile, is offered up to and coupled with a port in a wall of the process area. After conducting a sterilising cycle to sterilise the interface between the container and the port, a door in the port is opened to permit an operator located within the process area to gain access to the container and to remove a cap or lid from the container, thereby enabling the sterile interior of the container to be charged with sterile materials, or to permit sterile materials to be unloaded from the container into the process area.
Typically, the cap or lid of the container comprises a flexible foil which is sealed over the mouth of an opening provided in the container. The operator may remove the foil manually by punching it to rupture the foil, then pushing the broken foil pieces toward the rim or mouth to provide free access to the container interior via the mouth. Alternatively, the operator may use a sharp instrument to cut through the foil. Both methods are likely to generate some non-viable particulate material, which may enter the process area, contrary to good manufacturing practice codes in these industries. Both methods are also susceptible to causing perforation to be made in the operator's gloves, which could introduce viable particulate into the system, compromising the cleanliness of the process area. To avoid these problems, the foil may be provided with a tab which can be grasped by the operator to assist him in peeling the foil, in an unbroken state, from the container mouth. In such cases, care must be taken to ensure that whichever sterilizing means is used to sterilize the interface between the coupled container and dock is effective to sterilize all surfaces of the tab.
An effective coupling assembly for a container and a port is disclosed in WO96/21615 and comprises a collar of substantially tubular shape which docks with the port of a process area. The collar forms part of a transportable container. The port includes a door which opens inwardly into the process area. To the exterior facing side of the door are mounted ultraviolet (UV) or pulsed white light emitting sources which emit radiation at a frequency effective for sterilisation. On docking of the collar and port, a sealed chamber is established between the port and the collar and this chamber is sterilize by activation of the UV or pulsed white light lamps for a sufficient amount of time. Thereafter, the port door is opened and a foil covering the mouth of the collar can be removed to enable materials or components to be transferred between the container and process area. It will be appreciated that the foil will have a pull tab to facilitate its removal and that it is a matter of some difficulty to arrange the tab in such a way as to ensure that none of its surfaces are shadowed from the sterilizing radiation. Such shadowing may occur as illustrated in prior art Figure A, which shows a peel-off foil F covering the mouth M of the collar C of a container (not shown). The foil F is sealed to the mouth M by glue G. The foil F overlaps the mouth M at O, the overlap providing a grippable area which an operator can grasp to remove the foil F. However, it will be appreciated that while the upper surface F′ of the foil lies in the direct line of the sterilising radiation (shown by the arrows), the underside surface F″ of the overlapped portion is shadowed from the sterilising radiation by the foil F itself and this area constitutes a potential source of viable contamination of the entire process area once the foil has been peeled away.
SUMMARY OF THE INVENTION
The present invention seeks to overcome the above described disadvantages of heretofore used foils or seals and to provide an improved seal in which the risk of contamination is minimised. In particular, a seal which is especially suitable for use with the assembly described is WO 95/21615, is provided.
Accordingly the present invention provides a closure for a transportable container usable in the transfer of materials to or from a sterile or clean process area via a non-sterile environment, the closure being dockable with a port located in a wall of the process area to form a sealed connecting chamber, the closure comprising a collar portion arranged to lock with the port and a lid portion which is removably connected to the collar portion, the arrangement being such that following locking of the closure with the port and sterilization of the sealed connecting chamber, the lid portion is removable from within the process area to provide communication between the interiors of the container and the process area, the collar and lid portions being so formed and shaped that all surfaces thereof which form part of the sealed connecting chamber lie in use in the direct path of sterilising ultra-violet or pulsed white light radiation generated within the chamber with no surface or portion of a surface being shadowed from the radiation, characterised in that the lid portion includes a grip member grippable to assist in the removal of the lid portion from the collar portion without the generation of particulate material and in that all external surfaces of the grip member lie in use in the direct path of the sterilizing radiation. The lid portion may be bonded to or integrally formed with the collar portion and may be fabricated from plastics material by injection moulding or other suitable means.
In a preferred arrangement, the junction between the lid and collar portions comprises a thin, frangible web or material defining a fracture line between the two portions and the grip member is disposed so that when it is pulled in a direction away from the collar portion, the web or material is caused to break along the fracture line to release the lid portion from the collar portion.
The collar portion may be formed with an exterior surface which tapers towards the junction with the lid portion and the tapering surface may continue over and beyond the junction by the provision of a matching taper on the outer surface of the rim of the lid portion. Conveniently, the lid portion has a planar surface which covers the mouth of the collar and which faces the port in use, and the grip member is associated with the planar surface. In a preferred arrangement, the grip member is disposed about at least a portion of the rim of the lid portion. Most conveniently, the grip member is substantially triangular in cross-section, one side of the triangle comprising a tapered outer surface of the lid rim.
The collar is conveniently provided with a flange which is sealingly connectable to a surface of the container and the flange extends radially outwardly from the collar portion. Most conveniently, the flange is formed integrally with the collar portion. In a preferred arrangement, the flange has a planar surface which is sealingly connectable to a planar surface of the container. The surface of the flange which is connected to the container may be blat or sloped. The attachment of the surfaces of the container and collar may be made by any suitable means capable of providing a strong seal between the two, for example, by adhesive or by welding.
The closure may include a sensor means connectable with a sensory device provided in the port.
The invention also provides a transportable container having a closure as described above.
One embodiment of a seal according to the invention will now be described with reference to the accompanying drawings, in which:
REFERENCES:
patent: 4355729 (1982-10-01), Maguire
patent: 4903855 (1990-02-01), Ducay
patent: 5056659 (1991-10-01), Howes et al.
patent
Claessens Albert Louis Victor Jozef
Liepold Gerhard
McDonald Austin
Stollenmaier Donald
Duras Trading Limited
Maust Timothy L.
Ostrolenk Faber Gerb & Soffen, LLP
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