Platinum Cured Silicone Medical Grade Valve Diaphragm ISO 8 Clean Room Biocompatible FDA

Platinum Cured Medical Grade Silicone Valve Diaphragm

Premium medical grade silicone rubber diaphragm manufactured using platinum-cured technology in an ISO Class 8 certified clean room environment. Fully FDA compliant and biocompatible for critical medical and pharmaceutical applications.

Key Features

• Material: Platinum-cured liquid silicone rubber (LSR)
• Clean Room: ISO Class 8 certified manufacturing environment
• Compliance: FDA 21 CFR 177.2600, USP Class VI biocompatible
• Hardness: 50 ±5 Shore A
• Temperature Range: -50°C to +200°C
• Curing: Platinum-catalyzed addition cure, no peroxide byproducts
• Transparency: Optically clear, translucent option available

Applications

Pharmaceutical processing valves, medical device fluid control, biotech equipment, laboratory instrumentation, and food processing where ultra-purity is essential.

Quality Assurance

Full traceability with material certifications. ISO 9001:2015 and ISO 13485 compliant quality management.