Regulatory Compliance: Offering supply security, globally, Santoprene® TPV medical (MED) grades strictly comply with rigorous regulatory and testing rules and procedures:

  • Biocompatibility testing ISO 10993-10
  • US Pharmacopeia (USP) Class VI
  • Drug Master Files are maintained with the FDA
  • Production takes place at Good Manufacturing Practices (GMP) sites

Celanese BioPolymer Solutions
The Best Packaging Solutions Begin + Return to Nature


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