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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.
Advanced Elastomer Systems Santoprene® 181-64 Thermoplastic Rubber  (discontinued **)
Categories: Polymer; Thermoplastic; Elastomer, TPE; Thermoplastic Elastomer, Melt-Processible Rubber

Material Notes: A black thermoplastic medical grade elastomer with good fluid resistance, certified non-toxic by MEM elution test. It has USP Class VI Certificate of Compliance for biocompatibility and can be processed using injection molding, extrusion, blow molding or other melt processing techniques. Drug Master File has been established at US FDA National Center for drugs and biologics.

Key Features: MEM elution cytotoxicity to L-929 mouse fibroblast cells, 72 hr. exposure to rubber extract; NAmSA, MT023-100 test method; test unit, % cell lysis; typical value 0; USP physiochemical test for elastomer closures, heavy metals such as lead; NAmSA, CP020-004 test method; Test unit, ppm; typical value <1

Additional processing comments: This thermoplastic rubber is a shear-dependent material that can be processed on conventional thermoplastic equipment for injection molding, extrusion, or blow molding. For extrusion, a general purpose screw with a compression ratio of 2.5 to 3.0 is recommended. Material can be recycled. SANTOPRENE rubber is incompatible with acetal and PVC.

Values below are for injection molded plaques, side gated, 82.6 mm x 117.5 mm x 3.0 mm. Tensile properties measured across flow. Data provided by Advanced Elastomer Systems.

Advanced Elastomer Systems is now a part of ExxonMobil. This grade was removed from the Advanced Elastomers Systems standard product line before the ExxonMobil acquisiton.

Vendors:
Available Properties
  • Density, TPE-0105 (ASTM D792)
  • Hardness, Shore A, 5 Second; TPE-0169 (ASTM D 2240)
  • Tensile Strength, Ultimate, TPE-0153 (ASTM D 412)
  • Elongation at Break, TPE-0153 (ASTM D 412)
  • 100% Modulus, TPE-0153 (ASTM D 412)
  • Graves Tear Strength, TPE-0056 (ASTM D 624)
  • Graves Tear Strength, TPE-0056 (ASTM D 624)
  • Compression Set, TPE-0016 (ASTM D 412), 168 hrs.
  • Compression Set, TPE-0016 (ASTM D 412)
  • Tensile Set, 23°C, 168 hrs.; TPE-0053 (ASTM D 412)
  • Brittleness Temperature, TPE-0089 (ASTM D 746)
  • Processing Temperature
  • Drying Temperature, Desiccant drying for 3 hours recommended
  • Dry Time
  • USP Class VI
  
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Manufacturer Notes:
Advanced Elastomer Systems, Division of ExxonMobil

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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