Regular cleanroom validation is required in healthcare, medical studies, pharmaceuticals, laboratory services, aerospace, food, and a growing number of other sectors. And this requirement is met with certain criteria with TS EN ISO 14644 Clean Rooms and Related Controlled Environments standard. This international standard complies with many standards worldwide.
According to this standard, it is a requirement to determine the number of airborne particles for the classification and test measurement of clean rooms and clean air devices. The leakage test of the installed filter system is carried out on request.
TS EN ISO 14644 standard identifies clean rooms and controlled environments with these rooms. The basis of this standard is the Federal Standard 209E. The details of the ISO 14644 standard are as follows:
- Part 1: Classification of air purification by particle concentration
- Chapter 2: Monitoring the cleanroom performance of particle concentration and air cleaning for documentation purposes
- Section 3: Test methods
- Section 4: Design, construction and commissioning
- Section 5: Business
- Section 6: Terms and recipes
- Part 7: Separator housings (fresh air hoods, gloveboxes, insulators and mini-environments)
- Chapter 8: Classification of airborne molecular contamination
- Part 9: Classification of surface cleaning by particle concentration
- Section 10: Classification of surface cleaning by chemical concentration
- Section 14: Evaluation of suitability for use of equipment with particle concentration in air
Sources of pollution in clean room design are grouped into two groups: living pollutants and inanimate pollutants. Live pollutants are microorganisms such as bacteria, fungi and viruses. These microorganisms live in colony form on air, water and rough surfaces. The biggest source of living pollutants is people. About a thousand bacteria and fungi are spread from the human body per minute.
Inanimate pollutants are inanimate volatile substances in the air. In general, these substances are called powder if 100 is greater than μm. With the urbanization and industrialization, the number and quality of inanimate volatile substances in the air increases. Particles from the activities of the enterprises, the heating systems of buildings and the exhausts of vehicles are important inanimate pollutants. At the same time working machines emit particles into the air.
Our organization, UAF From the Accreditation Agency, Based on its accreditation authority in accordance with TS EN ISO / IEC 17025 standard, it performs clean room tests within the scope of environmental analysis.