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Cleanliness verification service

First, the scope of clean room cleanliness verification services:

  1. 1. Clean room cleanliness verification mainly refers to the detection of the dust concentration (suspended particle concentration) in the air in the clean room or related controlled areas. The cleanliness level of a clean room is assessed by the size and number of suspended particles . It is usually measured by the number of one or more size particles in a unit volume. It is the core of clean room testing and is used in aerospace, microelectronics, medicine, medical equipment, food and health care industries;

  2. 2. ISO14644, FDA, IEST, GMP and other relevant standards have clear requirements for clean room cleanliness verification;

  3. 3. Verification cycle: once every 6 months if it is above ISO5 level, it can be verified every 12 months if it is less than ISO5 level;

  4. Second, the verification method:

  5. 1. Refer to NEBB2009 clean room certification test standard, IEST-RP-CC006 clean room test;

  6. 2. Implement the 2015 edition of 14644-1 standard, the new version of the GMP standard;

3. Implement the Pharmaceutical Industry GMP Certification Guide 2003.

  1. Test conditions:

  2. 1. The air volume, air speed, air flow balance, and high-efficiency filter leak detection of the air-conditioning system;

  3. 2. The air-conditioning system runs above 30M (one-way clean room 15M);

  4. Fourth, test equipment:

  5. 1. American Lighthouse 100L laser particle counter;

2. American Lighthouse 28.3L laser particle counter;
Five, test qualifications:
1. American Lightouse authorized sales and service qualification certificate;
2. American Lightouse product training certificate;
Test report:
1. According to NEBB requirements or GMP certification guide 2003;
2. Contains SOP test files, qualification documents for testers, and valid calibration files for laser particle counters.

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