ISO Class 7 (10,000) mini-environment erected around equipment best suited for part, including multi-shot and spin stack
- Molding and assembly in Certified
ISO 13485:2003 environment - Molding in certified ISO Class 8 Clean Room
(Class 100,000) - Molding in Certified ISO Class 7
Mini-environment - Clean room certified to
ISO-14698 for
biocontamination
control
- Clean room certified to ISO-14644 for airborne
particulate concentration - Class 100,000 clean room assembly
- cGMP compliant
- Process validation and lot traceability
- Packaging and labeling including bar coding
- PEEK, polysulfone, Ultem, and other medical
grade materials