Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using direct contact with electrical or electromagnetic...
Patent
1997-09-15
2000-02-29
McKane, Elizabeth
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using direct contact with electrical or electromagnetic...
422 22, 422186, 4221863, 2504921, 2504961, 250428, A61L 210, A61L 202
Patent
active
060305789
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to apparatus for use in isolation and/or containment processes. More particularly, the invention relates to apparatus for assisting in component transfer during aseptic manufacturing processes which may be undertaken in a traditional clean room or in an isolation and/or containment system employed for operator and/or process protection.
Sterility maintenance is of vital concern in many manufacturing processes, to safeguard against contamination of products being manufactured in the process. Exemplary industries using aseptic production in a traditional manner or in isolation and/or containment facilities include the bulk and finished pharmaceuticals, medical devices, biotechnology, radiopharmaceutical and food industries.
In such facilities, a particular difficulty arises where components for use in manufacture are required to be transferred from one sterile process enclosure to another. In clean room applications, where components are introduced to the processing enclosure via an autoclave, extreme care is necessary to ensure that the potential for recontamination of the component containers is minimised. Traditionally, where isolation and/or containment is used, such transfers resulted in significant down-times during which isolation and/or containment facilities were breached to enable components to be entered and/or removed after which the integrity of the isolated and/or contained area had to be re-established to ensure the integrity of the processing environment. More recently, developments in isolation and/or containment facilities led to the introduction of specialised mating ports which can be deployed to enable components to be transferred from one area to the other without breach of isolation and/or containment. While representing a significant advance in isolation and/or containment technology, these ports are not without disadvantage. Commonly, the required location in the process enclosure is provided with a port which engages sealingly with a corresponding port of a transfer container, finite seals being used to mask gross potential contamination. The mated ports can then be opened to enable materials or components to be transferred from one area to another. One particular problem associated with the use of such transfer ports relates to their use in aseptic transfers. The presence of the seal or seals (normally made of silicon) is in itself a disadvantage in that it represents an area via which potential contamination which can be present on the exposed perimeter of the finite seals can be transferred into the sterile process enclosure of the isolation and/or containment facility. Additionally, suitable disposable ports used for component transfers are normally manufactured from plastics materials which do not withstand the high temperatures reached during autoclaving. Where these transfer ports need be used under aseptic conditions, their inability to withstand high temperature sterilisation, for example using steam, constitutes a significant disadvantage.
Under optimised conditions, the known transfer port described above is only capable of providing sterility assurance levels of 10.sup.-3 on the basis of finished product. While acceptable for many purposes, even greater levels of sterility assurance are desirable or required in some industries. For example, in the pharmaceuticals field, sterility assurance levels of 10.sup.-.sub.6 are desirable. That is to say, a reduction by a factor of a million or 10.sup.-.sub.6 of the viable contaminants is desirable. Other disadvantages relate to the composition of the ports in that they are complex toleranced elements which contain many parts bonded together with seals and so are relatively expensive to produce. Yet a further disadvantage is that manufacturing tolerances limit the effective physical size of the disposable plastic ports to 100 mm diameter or less.
It is an object of the present invention to provide apparatus and a method for the transfer of materials between process enclosures in a manner in which great
REFERENCES:
patent: 5130093 (1992-07-01), Wieczorek
patent: 5446289 (1995-08-01), Shodeen et al.
patent: 5447699 (1995-09-01), Papciak et al.
Bohan Thomas L.
Duras Trading Limited
McKane Elizabeth
Moazzam Fariborz
LandOfFree
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