Leading Manufacturers of Santoprene TPV Medical Grade Equipment’s In The USA.

1
Leading Manufacturers of Santoprene TPV Medical
Grade Equipment's In The USA.
2

• 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
• PeSyringe plunger tips
• ristaltic 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

3

• 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
• 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

4

• Supply Security and Consistency
• Manufactured at Good Manufacturing Practices
  (GMP) site.
• ISO 90012015 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

5
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 info_at_santopseal.com or
call us on [phone] to request your quote
today and learn about our medical tubing
solutions.