1. Test method:dust particle counting scanning inspection method.

2. Test range:filter material, filter frame seal and filter group support frame connection, support frame and fixed wall connection

3. Detection instrument:dust particle counter

4. Detection principle:According to the principle that dust particles scatter a certain amount of light in a certain proportion to their particle size under a certain intensity of light, the particle scattered light is converted into an electrical signal through photoelectric conversion, which is then displayed as the particle equivalent diameter and the corresponding number of particles after amplification and computer processing.

5. Detection procedure:

5.1 Use the sampling head of the dust particle counter to scan the air-inserted side of the filter. The sampling head is about 2cm away from the filter. Check along the inner frame of the filter. The scanning speed is less than 5cm/s.

5.2 When the detection cycle is 10min, the number of 0.5um particles is >20, and the alarm sounds, indicating that the leakage volume is above the standard. Repair or replacement is required.

5.3 Use epoxy resin glue to seal the leak or tighten the bolts, and then scan and inspect.

6. Detection cycle

6.1 Normal use. At least once a quarter;

6.2 Newly installed high-efficiency filters should be tested.

After the test is completed, connect the sampling plastic tube port to the rear panel of the dust particle counter for self-test. Then turn off the power. Use the dust particle counter to measure the results of the high-efficiency filter in the Class 100 clean area. The above measurements can show whether the high-efficiency filter has leaks. Whether it needs to be plugged or replaced, the filter must be retested after repair or replacement.

The longest recommended time interval is 24 months. DOP leak detection should be performed after HEPA is installed or replaced. When environmental monitoring shows that the air quality has deteriorated, or when the product sterility test fails, or the culture medium simulation filling test fails, leak detection can be performed as part of the deviation investigation. Filters that need to be leak tested also include HEPA used in drying tunnels and dry ovens.

Although the dust particle counter scanning method takes a long time to detect, generally one filter leak test takes about an hour, but the test equipment is low-priced and is commonly used by enterprises. There is no risk of negative effects, and it is more suitable for general pharmaceutical manufacturers to use for verification.