Santopseal Corporation Manufacturer has been selected as the primary supplier to market and sell products made from Santoprene™ thermoplastic vulcanizates (TPV) medical grades globally.
Santoprene Tpv In Medical Devices
Santoprene TPV is the first and foremost TPV that has provided the medical and healthcare market for a long time. Santoprene TPV Rubber is developed for the replacement of thermoset rubbers like silicone, butyl and EPDM due to its superior sealing properties and processing advantages. It also performs better for long-term pressure sets and chemical resistance than other styrenic thermoplastic rubbers (TPEs).
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
Why choose Santoprene TPV medical grades?
Material properties
- A great long-term compression set as well as stress relaxation to improve sealing performance
- A lower density (~20 percent) as compared to thermoset rubber may lower the weight of a part
- Stable at higher temperatures and greater chemical resistance over styrenic.
- Non-hygroscopic and colorable (no drying required before drying) grades are available
- Compatible with the PP bonding grade; offered that are compatible with ABS, PC COPE, ABS, etc.
Processing advantages
- High-precision molding; Eliminates trimming or deflashing
- Part consolidation and/or over-molding with 2K injection molding
- More efficient cycle times and no curing or mixing are required as opposed to thermoset rubbers
- Potential for in-process and recycling at the end of life
Read more: Benefits of Medical Grade Santoprene Tubing In The Medical Industry
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
Clearness (Heavy metallics, extractables)
- Carcinogenic N-nitrosamines at levels below detection limits (1ppb)
- Passed the heavy metals test USP NF and EU monograph.
- Testing for skin sensitization.
- The Drug Master File was maintained with FDA.
Supply Security and Consistency
- Manufactured at Good Manufacturing Practices (GMP) site.
- ISO 9001:2015 certified for quality management.
- Specially designed manufacturing line to ensure product consistency, with worldwide availability.
At SantopSeal, We manufacture various seals and tubing from medical-grade Santoprene. Our custom medical-grade Santoprene tubes and seals are USP class VI approved, RoHS regulated, and EU 2003/11/EC compliance.
We use medical grades of Santoprene ranging from 35 shores A to 90 shore A. The material we use is a Santoprene®. it is a proprietary thermoplastic elastomer developed by ExxonMobil Corporation. According to ExxonMobil “Santoprene medical-grade meets the USP (U.S. Pharmacopeia) Class VI requirement. Additionally, some ISO 10993 tests have been conducted, each medical grade Santoprene undergoes annual testing for cytotoxicity and heavy metals, and the Drug master file is maintained with the FDA”.
At SantopSeal, we use below listed Santoprene Medical grades in our products,
- Santoprene™ 8281-35MED
- Santoprene™ 8281-45MED
- Santoprene™ 8281-55MED
- Santoprene™ 8281-65MED
- Santoprene™ 8281-75MED
- Santoprene™ 8281-90MED
Our experts at SantopSeal Corporation are considerate about detailing and perfection in every product that we process here. Being an extruded medical-grade Santoprene tubing manufacturer, we have varied experience and knowledge over the years in rubber products.
Please discuss your requirements with us. Contact us with your details or email us at [email protected] or call us on (412) 444-1888 to request your quote today and learn about our medical tubing solutions.
