Imapure® Platinum Cured Silicone Tube for Regulatory Market (10 meters)

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 3 years Shelf Life