I. Leak detection cycle of high-efficiency filters and detection objects:
1. China's GMP inspection guidelines require that the high-efficiency filter be tested once after installation or replacement, and once a year thereafter;
2. FAD requires that the aseptic manufacturing workshop should conduct a leak check every six months in the guidelines for the production of sterile drugs;
3. The requirements of ISO14644 for leak detection of installed HEPA shall not exceed 24 months;
4. Detection objects include: high-efficiency air outlet, FFU, laminar flow hood, dry heat sterilization cabinet, tunnel oven sterilization, life safety cabinet, clean bench, cargo shower room, transfer window, clean shed, clean screen, clean unit And other high-efficiency filters.
Second, the detection method:
1. Refer to the US NEBB clean room certification test standard;
2. Comply with IEST-PR-CC034 HEPA and ULPA filter leak test;
3. Strictly implement GB / T 13554-2008 high efficiency air filter;
4. Implement the Pharmaceutical Industry GMP Certification Guide 2003.
1. After the wind speed, air volume, air flow, pressure difference and other tests are completed and qualified;
2. The air speed of the air conditioning system should be between 80% and 120% of the design air speed;
3. Clean room test status: static
Fourth, test equipment:
1. American ATI 2I (or 2H) aerosol photometer;
2. American ATI 5C (or 4B, 6D) aerosol photometer;
3. American ATI PAO-4 aerosol;
Five, test qualifications:
1. American ATI authorized sales and service qualification certificate;
2. American ATI product training certificate;
1. According to NEBB requirements or GMP certification guide 2003;
2. Contains SOP test files, qualification documents for testers, and valid calibration files for photometers.