Imapure®- Platinum Cured Silicone Transparent Tube

Product Description

Imapure® is Platinum Cured Silicone Tubing designed for peristaltic pump and fluid transfer in Pharmaceutical and Biotech applications. Imapure® is translucent silicone tubing known for its ultra smooth bore to prevent any particle entrapment. It is especially designed to comply with requirements of critical Food and Pharmaceutical standards of regulatory markets. 

Imapure® Characteristics: 

  • Manufactured from NSF-51 certified Platinum Cured Silicone Resin.
  • Manufactured by using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber. 
  • Manufactured & packaged in Clean Room Class of ISO -7, ISO 9001 QMS, ISO 14001 & OHSAS 18001 certified facility. 
  • Inspected by Laser online Inspection Device to maintain Critical Dimensional Consistency. 
  • Laser Etched For Traceability. 
  • Excellent Flexibility along with flex crack resistance. 
  • Excellent transparency with no odor and taste. 
  • Extractable study available upon request. 
  • 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 and length size available. 
  • Custom hardness available. 
Imapure® Applications:
  • Critical sterile transfer and filling in pharmaceutical industries 
  • Chemical and Analytical analysis 
  • Fermentation in biotech industries 
  • Vaccine transfer 
  • Biopharmaceutical & microbiological applications 
  • Sanitary application 
  • Load cell and media processing 
  • Drug delivery and sampling 
Imapure® Certification:
  • FDA 21 CFR 177.2600 - Complies to rubber articles intended for repeated use in contact with food. 
  • EP 3.1.9 - Complies to “Silicone Elastomer for closures & tubing.” 
  • German BfR VI - Complies to German Food Grade Standard. 
  • France: Arrete du 25 - Complies to France Food Grade Standard. 
  • USP Class VI - Complies to USP Class VI (Acute Systemic Toxicity, Intracutaneous Toxicity, Implantation Test). 
  • ISO 10993 - Complies with ISO 10993 - Part 1 Biological Evaluation of medical device. 
  • ROHS Certification - Restricted Content of EU listed Hazardous Substances. 
  • Phthalates / Bis Phenol / Plasticizer - Free of Any Phthalate / Bis Phenol derivatives & Plasticizers. 
  • TSE/BSE Free Confirmation - Available.
  • Shelf Life - 3 years from the Date of Manufacturing.
  • USFDA DMF Registration - Registered with USFDA DMF #26201.
  • Extractable Study - Extractable study available upon requested.
  • Validation Pack - Available upon request. 


NOTE: Price vary as per ID & OD of TUBE. Kindly email or call us for best available rate. 
Visit us: http://www.amipolymer.com/platinum_cured_silicone_transparent_tubing.html

Ami Polymer Pvt. Ltd.

  • IN
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Manufacturer/Innovator
Wholesale/Retail
Specifications
  • Selling Points
    Brand Name; International Approvals/Standards; Place of Origin; Price; Product Features; Product Performance; Quality Service; Reputation; Small Orders Accepted
  • Supplied from
    India
  • Measured In
    metre

Ami Polymer Pvt. Ltd.

  • IN
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Manufacturer/Innovator
Wholesale/Retail

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Ami Polymer Pvt. Ltd. resources (2)

  • News Single Use Assembly for Biopharmaceuticals Industry

    Our Ready to use Single use assemblies have the below features:
    • Made of tubings, PP connectors (Tri-clovers, Straight connectors, Y/ T/ X  connectors), Aseptic Connectors, Filters, Bags, Manifolds etc.
    • Manufactured and Packaged in Clean room of Class 10,000
    • Gamma irradiated for 25- 45 kGy for SAL Up to 10–6
    • Validated for Bioburden, Sterility Assurance Level and USP 788 Particulate testing 
  • Video Corporate Video

    Ami Polymer Pvt. Ltd. (APPL) was established in 1996 with the aim of being global leaders in field of silicone rubber product solutions to Food, Pharma and Engineering sectors. APPL is having dedicated manufacturing Clean Room facility of class 10000 in Silvassa (DNH) and distribution network in more than 20 countries including UK, USA. 1st Indian silicone product manufacturing company to have TOXIKON based E&L Studies, USP Class VI (USP 87 in vitro) for Platinum Cured Silicone Tubing & NSF-51 Certification.