Method and apparatus for manipulating pre-sterilized...

A - Human Necessities – 61 – M

Patent

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Details

A61M 39/18 (2006.01) A61L 2/00 (2006.01) A61L 2/08 (2006.01) B29C 65/00 (2006.01) B29C 65/02 (2006.01) B65B 55/02 (2006.01) B67C 7/00 (2006.01) B29C 65/04 (2006.01) B29C 65/10 (2006.01) B29C 65/48 (2006.01)

Patent

CA 2365557

The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB.TM., a suitable sterile field sphere can be created. The terminal ends of the multiple components remain withing the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

L'invention concerne un raccord, un assemblage ou un remplissage d'un ou de plusieurs composants préstérilisés dont chacun possède au moins une extrémité terminale servant à le fixer à un autre composant ainsi qu'un appareil pour effectuer ce raccord, la stérilité des composants étant maintenue. On rend permanent le raccord ainsi obtenu en collant ensemble les composés en contact au moyen d'une technique de collage au solvant, d'une scelleuse à radiofréquence, d'une scelleuse thermique ou par tout autre procédé approprié. De préférence, on effectue le raccord à l'intérieur du champ stérile actif. En utilisant un instrument à faisceau d'électrons à faible tension tel que MIN-EB<TM>, on parvient à créer un champ stérile approprié. Les extrémités terminales des composants multiples restent à l'intérieur du champ stérile jusqu'à ce que la possibilité de contamination à l'intérieur des composants scellés ne soit fortement réduite pour correspondre aux normes de l'industrie.

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