Certification

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.

PRODUCTION ENVIRONMENT

Cleanroom Standards – ISO7

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