cleanroom

A cleanroom is an environment with a controlled level of contamination such as dust, microbes, vapours 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 minimise 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.

Alsico High Tech provides cleanroom garments according to the IEST-RP-CC003.4 standard for all cleanroom classes.

ISO 14644-5 classification

ISO 14644-5 classification

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.

GMP EU classification

GMP EU classification

The maximum number of airborne particles permitted per m³ ≥ the tabulated size is used to classify the cleanroom into class A to D.

testing

testing

The most common tests performed on woven fabrics and garments for cleanrooms are:

  • Helmke Drum test or ASTM F51
  • Tear Strength (Elmendorf) (ASTM D2261)
  • BODY – BOX
  • Pore size ISO 9237
  • Particle filtration efficiency
  • Microbial penetration test EN ISO 22612
  • Linting test (Gelboflex) / Quick linting tester
  • Tensile Strength (ASTM D 5034-58035)
  • Air permeability (ISO 9237)
  • Water vapor permeability BS 7209
  • Weight (ASTM E96)
  • Electrostatic properties
Sterilising

Sterilising

Cleanroom garments and most important, all components of this one particular garment must be compatible with the validated sterilisation method:

  • ETO
  • STEAMSTERILISATION
  • 20 min à 121 ° C (2050 mbar )
  • 4 min à 134 ° C (3050 mbar )
  • BETA RADIATION
  • GAMMARADIATION (25 kGy per cycle)