Silicone rubber is a quite relative new elastomer, they started to be used for industrial and military application during the 50th, but later in the 60th first applications for food and pharma grade started.
Despite most of silicone rubber has inherent biocompatibility features, there are some differences considering applications. In general, we can consider the following categories:
– Pharma /medical below 30 days contact with human body or fluids
– Implant (that is out of the scope of this presentation)
Food application silicone rubber are regulated by country specific rules, although for my experience the most common ones are the American FDA 21.CFR 177.2600 and the German BFR section XV.
All these norms have similarities, as far as regards ingredients that must be listed into a positive list, and the percentage of extractable volatiles after tests done in different liquids reference at specific temperature /time ratio.
Silicone rubber for pharma and medical applications refer to American USP and European Pharmacopeia and differentiates from food grade silicone rubber for a lower volatile content and for biocompatibility tests that needs to be done “in vitro”.
Both applications consider post curing process aa s best practice, there is a formula that we can deliver under requests explaining the ideal process parameters.