Patent ID: 6440364
Filing Date: 2002-08-27
Classification: A61L

Abstract:
A process for sterilizing a bioabsorbable medical device using a sterilant gas mixture, comprising the steps of:providing an bioabsorbable medical device in a pouch; placing the bioabsorbable medical device and pouch in a chamber of a gas sterilizer; pulling a first vacuum on the chamber; injecting moisture into the chamber; charging a sterilant gas comprising a gas mixture of a sterilizing gas and an inert diluent gas into the chamber and maintaining the gas mixture in the chamber for a sufficient time to effectively sterilize the bioabsorbable medical device; pulling a second vacuum on the chamber; moving the medical device to a degassing chamber; then degassing the bioabsorbable medical device and pouch for a first degassing cycle by subjecting the bioabsorbable medical device and pouch to a vacuum at a first sufficiently effective temperature for a sufficient time to effectively remove substantially all of the moisture from the bioabsorbable medical device; and, then degassing the bioabsorbable medical device for a second degassing cycle by maintaining the vacuum and subjecting the bioabsorbable medical device and pouch to a second sufficiently effective temperature, which is greater than said first temperature, said second temperature being maintained for a sufficient time to effectively remove substantially all of residual sterilant gas, diluent gas, sterilization byproducts, and moisture from the bioabsorbable medical device and pouch.