USP Class VI and ISO 10993 are biocompatibility standards used to evaluate materials intended for contact with pharmaceutical products or biological systems.
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Silicone thermoplastic elastomers are widely used in biopharmaceutical processing due to their versatility, performance, and suitability for single‑use systems. Momentive offers a comprehensive portfolio of silicone thermoplastic materials for pharmaceutical applications, meeting ISO 10993 and USP Class VI requirements without added plasticizers or organic additives.
Silicone elastomers are commonly used in biopharmaceutical processing for tubing, pumps, seals, and other fluid‑contact components in single‑use and reusable systems.
Silicone elastomers offer flexibility, durability, and biocompatibility, making them well suited for single‑use biopharmaceutical applications that require consistent material performance.
USP Class VI and ISO 10993 are biocompatibility standards used to evaluate materials intended for contact with pharmaceutical products or biological systems.
Extractables and leachables refer to substances that may migrate from materials into process fluids, making them an important consideration for material selection in biopharmaceutical manufacturing.
Silicone elastomers are used in biopharm tubing, peristaltic pumps, and pinch valves to support fluid transfer, buffer handling, and sterile filling processes.
Peroxide‑free silicone elastomers are often selected for biopharm applications to help reduce potential by‑products associated with certain curing systems.
Low‑temperature silicone elastomers may be used in applications such as cold storage, low‑temperature fluid transfer, and handling of temperature‑sensitive pharmaceutical materials.