Method of terminal steam sterilization

Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Including additional step of preventing damage to sealed...

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422 26, A61L 200

Patent

active

052079830

ABSTRACT:
Disclosed is a method for terminal steam sterilization of a pre-filled plastic syringe or a pre-filled plastic cartridge, said method comprising the steps of: maintaining a head space in the syringe or cartridge of less than about 10%--of the fill--volume; providing at least a 10% leeway for the plunger therein to slide in response to pressure differential; and sterilizing the syringe or cartridge at an autoclave pressure that is less than the internal pressure of the syringe or cartridge.
Also disclosed is a method for terminal steam sterilization of a pre-filled glass syringe or pre-filled glass cartridge, said method comprising the steps of: maintaining a head space in the syringe or cartridge of less than about 10%--of the fill--volume; providing at least a 10% leeway for the plunger therein to slide in response to pressure differential; and sterilizing the glass syringe or glass cartridge at an autoclave pressure that is less than, equal to or greater than the internal pressure of the syringe or cartridge.

REFERENCES:
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patent: 3468471 (1969-09-01), Linder
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patent: 4406861 (1983-09-01), Beauvais et al.
patent: 4457327 (1984-07-01), Pepper
patent: 4673396 (1987-06-01), Urbaniak
patent: 4718463 (1988-01-01), Jurgens et al.
patent: 4834717 (1989-05-01), Haber et al.

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