FDA in the sterile drug production guidelines for sterile preparations for the production workshop every six months for a leak detection, gmp inspection guidelines in China is usually recommended once a year. Iso14644 The recommended maximum time interval for leak detection with installed hepa is 24 months. Dop leak detection should be performed after installation or replacement of hepa. When the environmental monitoring shows a deterioration of air quality, or when the sterility test fails, the media simulation filling test fails, can be used as part of the bias survey leak. Filters to be tested for leak testing include the hepa used in drying tunnels and dry ovens.
