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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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ExxonMobil Santoprene® 8281-65MED 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, extrusion or blow molding. 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: Blow Molding, Extrusion Blow Molding, Injection Blow Molding, 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: 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
Specific Gravity 0.920 g/ccASTM D792
Maximum Moisture Content 0.080
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 682 mm, 15 sec; ISO 868
Tensile Strength at Break 856 psiAcross Flow; ASTM D412
Tensile Stress at Strain 348 psi
@Strain 100 %
Across Flow; ASTM D412
Elongation at Break 480 %Across Flow; ASTM D412
Tear Strength 45.7 pli212°F, Die C; ASTM D624
 120 pli73°C, Die C; ASTM D624
Compression Set 19 %
@Temperature 22.8 °C,
Time 605000 sec
ASTM D395
 
Processing PropertiesOriginal ValueComments
Processing Temperature 175 - 230 °C
Rear Barrel Temperature 177 - 191 °C
Middle Barrel Temperature 179 - 193 °C
Front Barrel Temperature 185 - 199 °C
Nozzle Temperature 185 - 210 °C
Melt Temperature 143 - 216 °C
Mold Temperature 23.9 - 51.7 °C
Back Pressure 0.345 - 0.689 MPa
Clamp Pressure 41.0 - 69.0 MPa
Vent Depth 0.00100 in
Cushion 0.125 - 0.250 in
Screw Speed 100 - 200 rpm
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
ColorNatural Color
FormPellets
Injection RateFast
Max Regrind20%
Screw Compression Ratio2:1 - 2.5:1
Screw L/D Ratio16:1 - 20:1

Some of the values displayed above may have been converted from their original units and/or rounded in order to display the information in a consistent format. Users requiring more precise data for scientific or engineering calculations can click on the property value to see the original value as well as raw conversions to equivalent units. We advise that you only use the original value or one of its raw conversions in your calculations to minimize rounding error. We also ask that you refer to MatWeb's terms of use regarding this information. Click here to go back to viewing the property data in MatWeb's normal format.

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PADVA029 / 22719

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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