FDA guidance in the production of aseptic drugs recommended sterile preparation workshop for a semi-annual leak detection, our country in the GMP inspection guidelines are usually recommended once a year. ISO14644 The recommended maximum time interval for leak detection for installed HEPA is 24 months. DOP leak detection should be performed after HEPA installation or replacement. 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 that require leak testing include HEPA used for drying tunnels and dry ovens.
