The Problem
A BC pharmaceutical facility had pressure fluctuation in the Water For Injection loop serving a Class 100 cleanroom. Sterility could not be compromised.
Detection Method
Tracer gas injection from outside the cleanroom. Identified a microscopic leak at a diaphragm valve in the recirculation loop — accessed from the service chase without entering cleanroom.
Results
Valve replaced during next scheduled sterilization cycle. No sterility breach. Validation documentation preserved. Annual WFI loop surveys added.