Characteristics

• Manufactured by using PLC controlled latest Extrusion Technology and World Class Platinum Grade Silicone Resin.
• Manufactured from NSF-51 certified Platinum Cured Silicone Resin.
• Extractable and Leachable study from TOXIKON Lab, USA available upon request.
• Manufactured and Packaged in Clean Room Class of ISO-7 certified facility audited by TUV Nord.
• Inspected by laser online inspection device to maintain critical dimensional consistency.
• Laser etched for traceability.
• Complies with FDA 21 CFR, USP Class VI, USP Class 87 (in Vitro) and ISO 10993.
• Excellent transparency with no odor and taste.
• Excellent biocompatibility due to inertness to tissues and cells.
• Sterilizable by using different techniques like Autoclaving, Ethylene Oxide, Gamma Radiation.
• Available with FDA compliant color coding for ease of identification.
• Custom dimension, hardness and length size available.
• Available with Static Dissipative Formulation (107 to 109 Ω-cm)

Applications

• Peristaltic Pump
• Single-Use Assemblies
• Critical sterile transfer and filling in pharmaceutical industries
• Chemical and Analytical analysis
• Fermentation in biotech industries
• Biopharmaceutical & microbiological applications
• Sanitary application
• Load cell and media processing
• Drug delivery and sampling

Certifications

• TOXIKON base E & L Study available on request
• FDA 21 CFR 177.2600 Certificate
• NSF-51 (AESOP 6516; ISSUE 16) CERTIFIED SILICONE RESIN SLE-(PT)-30 to SLE-(PT)-80
• USFDA DMF Registration #26201
• Complies to EP 3.1.9
• German BfR VI Certificate
• France: Arrete du 25 Certificate
• USP Class VI Certificate
• ISO 10993 Certificate
• RoHS Certification
• Phthalates / Bis Phenol / Plasticizer free Certification
• TSE/BSE Free Certification
• 5 years Shelf Life
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