Equipment - Filter Integrity Testing Equipment

This SOP establishes the requirements for using and maintaining filter integrity testing equipment—including annual calibration, cleaning after each use with 70% IPA, storage in controlled environments, pre-use function checks, periodic tubing replacement, operation of bubble point testing, documentation in Equipment Maintenance Logs (EMLs), and repair per established procedures—to ensure accurate filter performance verification, equipment reliability, and compliance with USP <797>.

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