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how to certify a clean room

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2024-11-12  |  Visits:

Certification of modular clean rooms generally requires finding a professional and qualified third-party certification agency, who will sample and test the control indicators of the clean room, and issue A Clean Room grade certificate after checking with the relevant Clean room standards and meeting the test standards. Clean room Certification usually follows the following steps to ensure that it complies with relevant standards (such as ISO 14644)

CLEAN ROOM CERTIFY WORK

1. Determine the test items and parameter indicators

In the confirmation of the clean room test method, the items and parameter indicators that need to be tested must be clarified first, such as air cleanliness, temperature and humidity, pressure difference, etc. The selection of these indicators should be based on the characteristics and actual needs of the clean room.

 

2. Environmental monitoring

Use particle counters, temperature and humidity monitoring equipment, etc. to test the air quality, temperature, humidity, airflow, etc. of the clean room to ensure that it meets the required cleanliness level (such as iso7 or ISO5).

 

The Basics of Cleanroom Testing & Certification - SEPS Services



3. Testing and recording

Regularly monitor the concentration of particulates in the air, especially particles with a particle size of 0.5 microns and larger. The data needs to be recorded in detail and compared with the standard requirements.

 

4. Compliance with standards

The cleanroom must meet the cleanliness standards specified in ISO 14644-1, such as the number of particles at different levels, and the air change rate and airflow pattern must meet the requirements of the specification.

 

Clean Room | TMI Calibration


5. Third-party certification

The certification body conducts assessment and inspection to obtain iso 14644 certification or other industry standard certification. The certification body will issue a certificate of compliance to prove that the cleanroom meets the relevant requirements.

 

6. Continuous compliance

After certification, regular re-certification or supervision inspections are required to ensure that the cleanroom continues to meet the standards and carry out necessary maintenance and corrections.

 

Operating rooms Theatres Certification Validation


In short, the Certification Process includes equipment testing, compliance with standards, records and reports, and third-party verification.

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