Platinum-Cured SiliconeBiomedical/Pharmaceutical grade silicone gaskets are made with our proprietary molding process and engineered geometry to promote crevice-free and protrusion-free processing. The gaskets have exceptional biocompatibility, contain no contaminants or leachables and meet USP Class Vl-XXIII requirements. HelixMark Silicone Sanitary Gaskets are produced in our FDA registered medical device facility, following Good Manufacturing Practices (GMPs) in accordance with the Quality System Regulation. Helix Medical, Inc. has been certified to meet IS0 9001/EN 46001 quality standards. They are sterilizable by autoclave, ethylene oxide or gamma radiation within the users validated cycles and exposure levels. HelixMark Silicone Sanitary Gaskets are packaged 25 each in a convenient, resealable, zip-lock bag. Material certification and lot traceability are provided.