Apple Rubber's Class 10000, ISO 7, certified cleanroom facilities reflect our commitment to meeting customers' increased demands for cleanroom processing, medical LSR molding, heightened quality assurance, and full lot traceability.
Our Certification of Compliance was performed by R. Kraft, Inc. to the following standards:
- Air handling system supplying the cleanroom area has recently been certified to ISO 14644-2 2000.09.15 (Testing and Monitoring), which corresponds to FS 209E Class 10000.
- Air systems for the following areas have met ISO 14644-1 1999.05.10 guidelines to qualify for the following cleanliness classifications:
- Main Cleanroom - ISO Class 7 (10000) in an "As-Built" Mode of operation at .5 microns
- Inspection (Gown) Room - ISO Class 7 (10000) in an "As-Built" Mode of operation at .5 microns
- Complete processing including production, washing and packaging area
- Four (4) injection molding machines, primarily for Liquid Silicone Rubber, available for plastic and rubber
- Two (2) post-cure ovens
- Fully automated ultrasonic parts cleaning system
Apple Rubber's cleanroom expansion is one more way we are striving to be the leading sealing solutions provider for industries such as medical devices and electronic components where precision manufacturing, testing and assembly are critical.
For more information on our ISO Class 7 (10000) certified cleanroom capabilities contact Apple Rubber today.