Products for Medical Solutions:

  • Contract manufacturing
  • Complete cycle of services; design assistance, development, quality, regulatory, assembly, sterilization and packaging
  • Combination products 

Materials for Medical Solutions:

  • Silicone elastomers and gels
  • Bio-absorbable polymers

Cleanroom Capabilities:

  • Four cleanrooms totaling over 1,672 square meters/ 18,000 square feet of 10,000 (ISO 7) manufacturing space
  • Medical device assembly work at dedicated work stations within three of the cleanrooms
  • Fourth cleanroom dedicated to compounding of Active Pharmaceutical Ingredients (API) for drug-eluting devices
  • Four specialized mixers located in the API mixing cleanroom.
  • Specialized equipment for fabrication of devices available in cleanroom

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Robust Drug Combination Products
Experience, precision and robust quality systems enable Trelleborg Medical Solutions manufacturing facility in Tustin, California to develop unique solutions for drug combination products, dip coating, device assembly and other medical device production processes.

Relevant Facility Approvals

  • Licensed by the State of California for medical device
  • Licensed by the State of California for drug manufacturing
  • ISO 13485 certified
  • Registered with the FDA
  • New Hampshire Board of Pharmacy License
  • Japan MHLW Certificate of Foreign Medical Device Manufacturer
  • Korea MFDS Certificate of GMP