Is your silicone rubber compound FDA approved? Certified Class VI?
Our feedthrough sealants are fabricated from a platinum cured silicone resin system that is in compliance with 21 CFR 177.2600. It is approved for food contact in manufacturing equipment.
The silicone rubber is not Class VI certified because it does not need to be. We had a firm and urgent request from a customer for Class VI certification for use in an autoclave. We convinced the customer that if this was necessary, then every gasket seal, instrument sensor seal, door seal, instrument sensor wire, and every contact surface in the autoclave would have to be Class VI. All possible, but so expensive that no one would be able to afford it. The requirement quickly went away.
November 20, 2009 at 4:37 pm | Uncategorized | No comment