Microbiological monitoring of individual production areas includes surface contact tests (squeeze test), measurement of airborne germs as well as control of process air. Our production employees and production facilities are regularly checked by contact tests. In addition, measurements are carried out to determine the air particle count in the chambers and the process air. Trend analysis are performed to ensure long-term compliance with the standard.
Monitoring of environment parameters in the sterile area
Temperature, humidity and pressure measurements are generally carried out alongside productions and process validations.
Monitoring of environment parameters in the production area
The environment parameters and the differential pressure are checked and documented at regular intervals.