
Ami Polymer Pvt Ltd
Imapure® Platinum Cured Silicone Tube
Обычная цена
Rs. 0.00
Сумма налога включена.
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