Packaging Method To Enable Re-Sterilization Of Medical Device

摘要

A method of packaging pre-filled medical devices is disclosed. The method comprises producing a packaging having a front panel and a back panel defining a compartment capable of holding one or more medical devices wherein at least one of the front panel or top panel has a portion containing a gas permeable material while the remaining portion of the pouch is gas impermeable. This gas permeable material allows gas to pass through the material and contact the one or more articles contained within the compartment or allows gas to pass through the gas permeable material from the inside of the compartment to the outside of the container. Upon completion of sterilization, the pouch is sealed and the gas permeable portion is cut away leaving the sterilized medical device enclosed in a completely gas impermeable pouch.

主权项

1. A method of packaging and sterilizing a chemically sensitive medical device, comprising:
providing the medical device; providing a pouch having a non-permeable chamber and a gas-permeable header; placing the medical device in the pouch; sealing the pouch along the gas-permeable header, such that the non-permeable chamber remains accessible through the gas-permeable header; sterilizing the medical device with a sterilizing agent provided through the gas-permeable header to the non-permeable chamber; sealing the medical device in the non-permeable chamber within the pouch; and removing the gas permeable header resulting in a medical device packaged within the non-permeable chamber and sterilized.