Environmental Monitoring Qualification
The environmental monitoring qualification (EMQ) is the testing and documentation that verifies the HVAC system, cleanroom design, cleaning and disinfection program, personnel gowning, room activity and equipment are all capable of meeting predefined quality limits for viable and non-viable contamination.
We have extensive experience designing studies to qualify the environment in your cleanrooms and leverage the data collected to create procedures for an ongoing environmental monitoring program. We have years of experience qualifying aseptic processing areas and designing studies according to your internal requirements and International Organization for Standardization (ISO) 14644-1:2015 and Eudralex Volume 4 Annex 1 requirements.
Some of the projects we have completed for our clients include the following:
Baseline Studies,
Environmental Monitoring Qualification of Cleanrooms,
HVAC Shutdown Recovery Studies,
Airflow Visualization Smoke Studies,