There are too many factors affecting the service life of the high efficiency filter (such as the humidity of the workshop, the dust, the continuous / intermittent operation mode of the air-conditioning system and the maintenance of the plant and facilities). The GMP standard seems to be difficult. No specific requirements. It is recommended to confirm that HVAC belongs to the key system of drug production. It should be revalidated once a year. According to the measured wind speed and the leak detection of high efficiency filter, the HVAC should be replaced or not, Settlement bacteria (planktonic bacteria) to monitor compliance with the requirements do not need to be replaced.
