GOOD MANUFACTURING PRACTICES
Our facility adheres to Good Manufacturing Practices and standards.
100% INTEGRITY TESTING IN MANUFACTURING
Each filter cartridge passes the Integrity Test correlated to the bacterial challenge test results.
VALIDATED PRODUCTION PROCESS
Our products are fabricated using a validated manufacturing process. Principles of statistical control and determinations of process capability are applied to critical variables in the filter fabrication process. In-process controls assure stability of the process.
ISO® 9001 QUALITY STANDARD
Our manufacturing facility is approved by an accredited registering body to the appropriate ISO 9001 Standards.
Cleanroom Standards – ISO7