Clean Room Manufacturing
Precision Associates’ clean room is, in effect, a miniature replication of our regular manufacturing facility. Nearly all of the equipment used in our regular manufacturing processes is also included in our 6,000 sq. ft. ISO14644-1, class 7 (10,000) clean room.
The compounds we regulary mold include USP VI certified grades of Silicone, EPDM, Viton® and Perfluoroelastomer, plus Biomedical grades of silicone. Many of our materials have passed ISO 10993-5 testing for cytotoxicity. Implantable silicone grades can be manufactured by our sister company, Sil-Pro. We mold both HCR and LSR silicone rubbers. Custom colors are available. Other polymers requiring clean room manufacturing may also be manufactured for you in this facility.
Many of your existing custom molded parts, plus most of PAI’s 2,600+ O-Ring molds may be used without modification in the clean room using medical grade compounds or other materials. For new items, our on-site mold shop will produce a tool to your specifications.
Segregated equipment and work rooms are maintained for silicone and non-silicone mixing and secondary operations.
As with all products manufactured by PAI, 100% visual inspection is automatically included, as well as complete documentation of the manufacturing process. Applicable certifications are provided with shipment, and all material and process traceability is maintained indefinitely.