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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.
ExxonMobil Santoprene® 8281-55MED Thermoplastic Elastomer
Categories: Polymer; Thermoplastic; Elastomer, TPE; Thermoplastic Vulcanizate Elastomer (TPV)

Material Notes: A soft, colorable, specialty, non-hygroscopic thermoplastic vulcanizate (TPV) in the thermoplastic elastomer (TPE) family. USP Class VI Certificates of Compliance exist for representative samples of our medical grades. Prior to release, each medical grade lot undergoes a Cytotoxicity study using the ISO elution method and a Physico-Chemical - Elastomeric Closures test for heavy metals such as lead. This grade of Santoprene 8000 TPV is shear-dependent and can be processed on conventional thermoplastics equipment for injection molding or extrusion. It is polyolefin based and completely recyclable.

Key Features:

  • Based on a series of biocompatibility tests conducted on representative grades, this grade should meet the USP (U.S. Pharmacopeia) Class VI requirements for plastics.
  • Additionally some ISO 10993 tests have been conducted.
  • Each medical grade undergoes annual testing for cytotoxicity and heavy metals.
  • Drug master file maintained with the FDA.
  • EU and China RoHS compliant.
Applications:
  • Medical – Soft Touch Grips, USP Class VI Seals and Gaskets
Uses:
  • Medical/Healthcare Applications
Processing Method: Injection Molding and Multi Injection Molding

Availability: Africa & Middle East, Europe, North America, Asia Pacific, Latin America and South America

Information provided by ExxonMobil Chemical

Key Words: EU 2003/11/EC; RoHS Compliant; USP Class VI
Vendors:
Available Properties
  • Specific Gravity, ASTM D792
  • Maximum Moisture Content
  • Hardness, Shore A, ISO 868, 2 mm, 15 sec
  • Tensile Strength at Break, ASTM D412, Across Flow
  • Tensile Stress at Strain, ASTM D412, Across Flow
  • Elongation at Break, ASTM D412, Across Flow
  • Tear Strength, ASTM D624, 212°F, Die C
  • Tear Strength, ASTM D624, 73°C, Die C
  • Compression Set, ASTM D395
  • Processing Temperature
  • Rear Barrel Temperature
  • Middle Barrel Temperature
  • Front Barrel Temperature
  • Nozzle Temperature
  • Melt Temperature
  • Mold Temperature
  • Back Pressure
  • Clamp Pressure
  • Vent Depth
  • Cushion
  • Screw Speed
  • USP Class VI
  
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Manufacturer Notes:
Exxon Chemical

Category Notes
Plastic
Thermoplastic Elastomer

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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.
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