Facilities grappling with USP 797 and USP 800 verify their compliance through cleanroom certification. Airflow measurements, leakage testing, and environment measurements (differential pressure, temperature, and relative humidity) are documented and certified. Non-cGMP certified facilities do not generally have ongoing monitoring of their cleanroom space and have difficulties identifying when intervention is required. The challenge for facility managers is how to monitor their day-to-day operations without disrupting the facility or adding significant cost.
Existing cleanrooms have numerous non-invasive options to supplement their facility with monitoring products. New construction will find “combined” control systems for FFU operation/optimization containing environment monitoring to be cost-effective and convenient solutions to monitoring their facility and optimizing air-management.
Without airflow monitoring the easiest way to monitor cleanroom airflow changes/stability is by monitoring the differential pressure maintained between the controlled environments and their surrounding space (a failed or compromised FFU will materially impact the differential pressure in a small cleanroom). Significant changes in differential pressure can point to filter blockages and/or FFU failures.
Most cleanrooms follow a simple floor-plan layout with compounding or mixing rooms connected to an ante-room. For cleanrooms where monitoring systems were not designed-in, solutions are available to assist in the process: monitor the key parameters — differential pressure, temperature, RH; notify and alarm if these parameters change significantly; capture the data for reporting purposes (data log).
The simplest solutions are stand-alone sensors that can be mounted inside the cleanrooms that display their value so the cleanroom staff can manually check the values, determine if the values have changes significantly (manual notification), and jot them in a log for future reference (data log).
This cleanroom tip was taken from “Monitoring Considerations for Pharmaceutical Cleanrooms” by Howard Abramowitz of AirCare Automation Inc. The article originally appeared in the March/April 2016 issue of Controlled Environments.