Silicone is widely used in pharmaceutical applications for two major reasons. First, and foremost, is safety. Silicone does not contain plasticizers or other additives that could leach into a drug product and cause toxicological issues. Second, silicone is highly flexible and tear-resistant, making it a good choice for sealing fluids in downstream processes. To make Silicone gaskets, there are two cure system options with silicones, however, that produce materials with different characteristics, whose impact should be considered before selection. Silicone materials may be cured using free radical (peroxide) or addition (platinum) cure mechanisms. Platinum-cured and peroxide-cured silicone gaskets can both be made to USP Class VI and other industry specifications, but a platinum-cured gasket has a higher purity and lower leachability than peroxide-cured silicone.
Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries.
European leader in FDA-compliant gaskets and validation components. Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries. Our screen gaskets are not used the same way as conventional filters, although they can be considered a filter. Conventional filters are built differently and have many layers to prevent particles to pass through, these can reach efficiencies of almost 100%. A particle comes in many different shapes.
For example, a hair has a diameter of Ø 0,1 mm but the length can be centimetres long. If the hair arrives perpendicular to the screen it might pass a 100 mesh screen. With a conventional filter, the second or third layer will prevent the hair to pass. Retention’s of standard screens are calculated according to international standards using perfectly round glass spheres. Our screens are only one layer and therefore they cannot be considered the same as a filter. Each screen gasket has a high-performance gasket made out of one of the validated compounds that we use for our standard Sanitary Gaskets range.
Peroxide-cured gaskets contain a small residue of 2,4 DCBA (dichlorobenzoic acid) as a by-product of the curing reaction, platinum-cured gaskets have no 2,4 DCBA residues, its only by-product is H2O. In some critical bioprocesses, the small amount of DCBA might harm the media that is made. The relative value and impact of these characteristics should be evaluated carefully when selecting the silicone type for fluid handling applications.
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