Tustin
Location: Tustin, California, USA | Size: 5,110 square meters/ 55,000 square feet
Products for Healthcare & Medical:
- Contract manufacturing
- Complete cycle of services; design assistance, development, quality, regulatory, assembly, sterilization and packaging
- Combination products
Materials for Healthcare & Medical:
- 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
Relevant Facility Approvals:
- Licensed by the State of California for medical device and drug manufacturing
- ISO 13485 certified
- Registered with the FDA