A cleanroom is an environment with a controlled level of contamination such as dust, microbes, vapors and aerosol particles. A cleanroom is defined by the number of particles per cubic meter at a specified particle size. Cleanrooms are used in almost every industry where particles can harm the manufacturing process or contaminate the product. This includes pharmaceuticals, microelectronics, life sciences, biotechnology, food packaging, electronics, automotive and optical industries. Air filtration and airflow management control the concentration of airborne particles inside the room. Personnel selected to work in cleanrooms undergo extensive training. They enter and exit the cleanroom through airlocks, air showers and/or gowning rooms, and they are trained to wear special clothing designed to retain pollutants that are naturally generated by skin and the body (skin flakes, hair,..). Cleanroom garments are designed to minimize or eliminate particle release from the wearer’s undergarments and prevent the cleanroom from contamination. Protection of the product made in the cleanroom is essential. The type of cleanroom garments used should reflect the cleanroom and product specifications. Union MicronClean provides cleanroom garments according to the IEST-RP-CC003.4 standard for all cleanroom classes. Cleanrooms are classified according to the number and size of particles permitted per volume of air. ISO 14644-5: cleanrooms and associate controlled environments: Part 5 – operations This standard provides the basic requirements for operating and maintaining cleanrooms and associated controlled environments and ranks cleanrooms in ISO classes. The system is rated on the number of airborne particles per m³ and the size of those particles, with 1 being the most hygienic cleanroom environment. The smaller the number, the cleaner the air in the room. The maximum number of airborne particles permitted per m³ ≥ the tabulated size is used to classify the cleanroom into class A to D. The most common tests performed on woven fabrics and garments for cleanrooms are: Cleanroom garments and most importantly, all components of the garment must be compatible with the validated sterilization method:
ISO 14644-5 classification
GMP EU classification
Testing
Sterilising
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