ExxonMobil Santoprene® 8281-35MED Thermoplastic Elastomer

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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® 8281-35MED 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: This grade meets 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
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Physical Properties	Original Value	Comments

Specific Gravity	0.910 g/cc	ASTM D792
Maximum Moisture Content	0.080

Mechanical Properties	Original Value	Comments
Hardness, Shore A	38	2 mm, 15 sec; ISO 868
Tensile Strength at Break	377 psi	Across Flow; ASTM D412
Tensile Stress at Strain	131 psi @Strain 100 %	Across Flow; ASTM D412
Elongation at Break	360 %	Across Flow; ASTM D412
Tear Strength	22.8 pli	212°F, Die C; ASTM D624
	51.4 pli	73°C, Die C; ASTM D624
Compression Set	13 % @Temperature 22.8 °C, Time 605000 sec	ASTM D395

Processing Properties	Original Value	Comments
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	Processing
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
Screw Speed	100 - 200 rpm

Compliance Properties	Original Value	Comments
USP Class VI	Yes

Descriptive Properties
Color	Natural Color
Form	Pellets
Injection Rate	Fast
Screw Compression Ratio	2:1 - 2.5:1
Screw L/D Ratio	16:1 - 20:1
Suggested Max Regrind	20%

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PADVA026 / 22716

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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