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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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Advanced Elastomer Systems Santoprene® 281-55 Thermoplastic Rubber  (discontinued **)
Categories: Polymer; Thermoplastic; Elastomer, TPE; Thermoplastic Elastomer, Melt-Processible Rubber

Material Notes: A colorable 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: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
 
Physical PropertiesOriginal ValueComments
Density 0.970 g/ccTPE-0105 (ASTM D792)
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 555 Second; TPE-0169 (ASTM D 2240)
Tensile Strength, Ultimate 4.70 MPaTPE-0153 (ASTM D 412)
Elongation at Break 400 %TPE-0153 (ASTM D 412)
100% Modulus 0.00170 GPa
@Strain 100 %
TPE-0153 (ASTM D 412)
Graves Tear Strength 9.00 kN/m
@Temperature 100 °C
TPE-0056 (ASTM D 624)
 22.0 kN/m
@Temperature 23.0 °C
TPE-0056 (ASTM D 624)
Compression Set 25 %
@Temperature 100 °C
168 hrs.; TPE-0016 (ASTM D 412)
 23 %
@Temperature 23.0 °C,
Time 605000 sec
TPE-0016 (ASTM D 412)
Tensile Set 6.0 %23°C, 168 hrs.; TPE-0053 (ASTM D 412)
 
Thermal PropertiesOriginal ValueComments
Brittleness Temperature <= -60.0 °CTPE-0089 (ASTM D 746)
 
Processing PropertiesOriginal ValueComments
Processing Temperature 177 - 232 °C
Drying Temperature 82.0 °CDesiccant drying for 3 hours recommended
Dry Time 3 hour
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes

**
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PADV93 / 22683

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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