Sanofi – Environmental Monitoring Tube Disconnect

Kevin Louie, Deputy Director, Automation Site Support, Sanofi

Our Environmental Monitoring (EM) system uses vacuum to pull a defined volume of air each sample. The tubing became disconnected at an unknown time. Using SeeQ I defined periods of sampling for flowrate values between rest state and setpoint. I then calculated and trended the durations of these sample periods over a 1-day aggregated period for all sample events. Then we determined: When the tubing was first disconnected based on a change in duration to reach flowrate setpoint What maintenance work was involved that might have led to the disconnect How many batches were impacted to isolate vs which ones were okay to release for sale & distribution.