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Avient Distribution has been selected as the primary distributor to market and sell the Santoprene™ TPV medical grades globally.
Santoprene™ TPV has been the first and leading TPV to consistently serve the medical market for multiple decades. Santoprene TPVs are designed to replace thermoset rubber (Silicone, Halobutyl, EPDM, etc.) given superior sealing performance and processing benefits. They also outperform other styrenic thermoplastic elastomers (TPEs) in long term compression set and chemical resistance.
Compared to other materials, Santoprene thermoplastic vulcanizates (TPVs) offer:
- Total system costs reduction through manufacturing simplification
- Weight reduction through part redesign
- Excellent performance over time
- Superb aesthetics
- In process recycling during the conversion phase and the potential for recycling at the end of life*
* When a finished part reaches its end-of-life, components made with Santoprene TPV can potentially be recovered and recycled by those with the necessary recycling equipment.
Common Applications:
- Syringe plunger tips
- Peristaltic pump tubing
- Caps and closures
- Strain relief devices
- O-rings, seals and gaskets, valves, and diaphragms
- Wearable devices
- Wire and Cable and Connectors
Summary of properties and characteristics
- Excellent long term compression set and stress relaxation for sealing performance
- Lower density (~20%) than thermoset can reduce part weight
- Better stability at higher temperatures and chemical resistance than styrenic TPEs
- Colorable and non-hygroscopic (no pre-drying required) product availability
- Compatible with PP; Bonding grades available compatible with PC, ABS, COPE, etc
- High precision molding; eliminates deflashing or trimming
- Overmolding and/or part consolidation with 2K injection molding
- Faster cycle times (< 60sec) and no mixing or curing versus thermoset
- Potential for in process and end of life recycling
Regulatory and Safety Compliance:
Biocompatibility of raw materials
- US Pharmacopeia (USP) Class VI
- ISO 10993-1 Biocompatibility:
- ISO 10993-5 ”Cytotoxicity”
- ISO 10993-6 “Muscle Implantation”
- ISO 10993-10 ”Intracutaneous Irritation”
- ISO 10993-11 ”Acute Systemic Toxicity”
Ability to withstand sterilization with minimal degradation:
- Steam (132°C) (up to 100 repeatable sterilizations) and autoclave
- Ethylene oxide
- Gamma radiation
Cleanliness (Heavy metals and extractables)
- Carcinogenic N-nitrosamines below detection limit (1ppb)
- Passed heavy metals test - USP NF and EU monograph
- Skin Sensitization testing
- Drug Master File maintained with FDA
Supply Security and Consistency
- Manufactured at Good Manufacturing Practices (GMP) site
- ISO 9001:2015 certified for quality management
- Dedicated manufacturing line for product consistency with global availability
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