Airflow Visualization Study to address audit observations
Our client, a CDMO in the biopharmaceutical industry retained the services of the Brevitas team to help them address gaps in the qualification of two Grade C cleanrooms and associated airlocks.
A CDMO biopharmaceutical client qualified two Grade C cleanrooms and associated airlocks, but during the regulatory audit, gaps were identified that an air visualization study and room recovery test were not performed.
The Brevitas team was retained to develop the appropriate documentation and provide execution to address the gaps identified during the audit.
A qualification protocol for airflow visualization and room recovery test was developed based on the test methods described in ISO 14644-3:2019 Cleanrooms and associated controlled environments – Part 3: Test methods for the airflow direction test and visualization, and room recovery.
A MiniColt 4S portable smoke system designed for cleanroom environments was used to generate a stream of particles to visualize the airflow. A video camera was used to record the airflow patterns from areas of high cleanliness (HEPA filter) to lower cleanliness (return air duct). The airflow direction test and visualization were performed on the rooms while they were in a static condition, and again, in a dynamic condition.
A recovery test was performed on the two Grade C cleanrooms and their associated airlocks to determine the ability of the room’s HVAC system to reduce the concentration of airborne particles by dilution.
The recovery performance was evaluated by using the 100:1 recovery time. This is defined as the time required for decreasing the initial concentration of particulates by a factor of 100 times.
An AeroTrak™ 9306 handheld particle counter was used to measure the baseline cleanliness of the rooms. The MiniColt 4S portable smoke system was used to contaminate the room to 100 times above the baseline cleanliness level, and the time required for the room to recover was measured.
All rooms met the recovery time guidance value of less than 20 minutes given in the guidance EU GMP Volume 4. Annex 1. The execution of the tests cases was successfully completed within the three-day time slot, allowing the client to meet their manufacturing schedule.
The Brevitas team contributed to the success of the project by:
- Developing the air visualization and room recovery qualification protocol
- Executing the qualification protocol using a smoke generator and a video camera to visualize the airflow patterns, and an air particle counter to measure the room recovery time
- Performing data analysis on the room recovery data
- Developing the final qualification report
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