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Medical grade elastomers manufacturing solution

Integrated cleanroom production : Definition

Cleanrooms are designed to efficiently control air quality and reduce contamination. Cleanrooms serve the medical, pharmaceutical, cosmetic and surgical markets, to answer high expectations due to increasingly demanding new legislations, and requirements.

Sterne Certified Cleanroom : Our Facilities & commitments

Our 650 m2 cleanroom are devoted to produce seals and other silicone parts for medical applications. Sterne operates into 3 separated areas: 400 m2 ISO 6 cleanroom ( used to be Class 1000) and 250 m2 ISO 8 cleanroom (used to be Class 100-000)

These ultra-protected production areas have regulated access and receive regular particulate and bacteriological controls to offer the highest grade silicone rubber products.

Sterne processing: An added value manufacturing

Sterne only process platinum cured silicone of different medical grades in its cleanrooms, such as short or long term implantable silicones, USP class VI silicone rubber and ISO 10993 compliant materials. These medical grades rubbers associated with a sophisticated production technology enable Sterne to offer high precision & quality silicone products, which can be implanted into the human body.

These protected environment are ideal to manufacture clean silicone customized parts such as:

• short/long term implantable silicone devices
• Silicone eyelets
• Silicone septum
• Silicone medical devices & components
• Silicone drains
• Urology silicone tubes
• Silicone gastric rings, gastric bands
• Silicone rubber catheters
• Syringe silicone components
• Silicone O-rings
• Silicone diaphragms
• Silicone cushions
• Silicone valves
• Silicone probes
• Silicone rubber parts for infusion sets (IV sets)
• Silicone components
• Fluted drain profile in silicone
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