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.
Platinum Silicone is the preferred choice for many pharmaceutical and biopharmaceutical processes where purity, flexibility and consistent performance are essential. Thanks to its platinum curing process, the material offers lower extractables and leachables compared to peroxide-cured silicone, making it particularly suitable for critical fluid handling applications.
Ultrapharma manufactures its Platinum Silicone gaskets using validated compounds and tightly controlled production processes to ensure consistent quality from batch to batch. Each compound is supported by comprehensive technical documentation and complies with the relevant pharmaceutical standards, giving customers confidence in both product performance and regulatory compliance.
With excellent flexibility, tear resistance and outstanding performance during repeated CIP and SIP cycles, Platinum Silicone provides a reliable sealing solution for demanding hygienic processes. Whether used in pharmaceutical manufacturing, biotechnology or high-purity water systems, Ultrapharma’s Platinum Silicone gaskets are engineered to protect product integrity and maintain process reliability throughout their service life.
High purity. Proven performance. Trusted sealing solutions.
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.
Available Compounds:
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