Pharmaceutical Grade Silicone
PHARMACEUTICAL GRADE SILICONE & TUBING THAT YOU CAN COUNT ON.
As a leading, worldwide supplier of Biomedical/Pharmaceutical grade silicone tubing and silicone products, SPS-Canada is dedicated to satisfying the needs and cost requirements of our customers. Applying proprietary manufacturing processes to Dow Corning Silastic®, Wacker Silicones Corporation, General Electric Company and Nusil Technology materials, our platinum-cured silicone product line demonstrates superior physical performance characteristics without the risk of peroxide or leachable contamination.
During manufacturing, a strict contamination control policies are followed in accordance with appropriate principles of CGMPs to ensure consistent product purity and quality. Frequent monitoring of air, critical surfaces, and equipment, verifies compliance to these policies. Contamination control, batch traceability and change control all converge to improve risk management.
Our tubing and molded assemblies are qualified to a range of globally recognized monographs, including:
• USP Class VI (Biological Reactivity) tests
• European Pharmacopoeia 3.1.9 (Silicone Elastomer for Closures and Tubing)
• USP (Physicochemical Tests – Plastics)
• USP (Elastomer Closures for Injection – Physicochemical Test Procedures)
• FDA Food Grade (21 CFR 177.2600)
• Selected Sanitary 3-A standards
• Japanese Pharmacopoeia (Section 11: Plastic Containers for Pharmaceutical Products)
• ANSI/NF Standard 51
SOME OF OUR PHARMACEUTICAL CLIENTS