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Imapure® Platinum Cured Silicone Tube
Ami Polymer Pvt Ltd

Imapure® Platinum Cured Silicone Tube

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Imapure® is platinum cured silicone tubing designed for peristaltic pump and fluid transfer process in pharmaceutical and biotech industries. Imapure® is a translucent silicone tubing known for its ultra-smooth bore to prevent any particle entrapment. It is specially designed to comply with requirement of critical food and pharmaceutical standards of regulatory markets.

 CHARACTERISTICS:

  • Manufactured by using PLC controlled latest extrusion technology and world class platinum grade silicone resin.
  • Manufactured and packaged in clean room class of 10000 facility audited by TUV Nord.
  • Inspected by Laser online inspection device to maintain critical dimensional consistency.
  • Excellent flexibility along with flex crack resistance.
  • Excellent transparency with no odor and taste which enhances shelf life.
  • Excellent biocompatibility due to inertness to tissues and cells.

 APPLICATIONS:

  • Peristaltic Pump
  • Drug Delivery System
  • Cell Process
  • Laboratory Applications
  • Bio-Pharma Process
  • Food And Beverages
  • Medical Applications
  • Vials Filling

CERTIFICATIONS:

  • FDA 21 CFR 177.2600
  • USP CLASS VI
  • TOXIKON 
  • USP CLASS 87 (IN VITRO)
  • DMF# 26201
  • ISO 10993-10 SENSITIZATION
  • ISO 10993-11 SYSTEMIC TOXICITY
  • ISO 10993-5 CYTOTOXICITY
  • ISO 10993-3 GENOTOTOXICITY
  • BPA FREE
  • TSE BSE FREE

TECHICAL SPECIFICATIONS:

  • Laser Based Auto Inspection Device.
  • Color Coded Tubing For Identification.
  • Permanent Laser Printing Available with Sterilizable Packing.
  • Manufactured by Using PLC Controlled Latest Extrusion Technology And World Class Platinum Grade Silicone Resine.
  • Manufactured And Packaged in Clean Room Class of 10000 Facility Audited by TUV NORD.
  • Inspected by Laser Online Inspection Device to Maintain Cirtical Dimensional Consistency.
  • Excellent Flexibility Along with Flex Crack Resistance.

VALIDATION PACK AVAILABLE UPON REQUEST:

Covers Manufacturing Process, Physical Properties, MSDS, Chemical Compatibility Chart, Toxicological Studies, Biocompatibility Studies, Extractable Studies.

STORAGE GUIDELINES:

  • Store in Cool & Dry Place.
  • Keep Away From Direct Sunlight.
  • Shelf Life 3 Years from Manufacturing Date.
  • Available in Sterilizable Packaging.

STERILIZATION METHODS:

  • Steam
  • Gamma
  • ETO