ISO 14644ff (Clean Rooms)
Cleanrooms are areas where particular attention is paid to the concentration of impurities due to particles and microbial impurities. They are designed as to minimize the development, accumulation and sedimentation of particles disturbing or damaging during the manufacturing process. A cleanroom facility includes all the relevant buildings, air conditioning systems, connections and operating media. Classification of the cleanrooms will be done depending on the sector acc. to EN ISO 14644, the requirements placed by GMP/FDA or the standards acc. to VDI 2083 and should be done at semi-annual or annual intervals depending on the cleanroom class.
Productions or quality relevant activities and manufacturing processes are steadily expanding from the key areas of cleanroom technology, e.g. microelectronics, aerospace industry as well as pharmaceutical production and healthcare systems, to food industry, precise mechanics, optics, laser technology and PCB (Printed Circuit Board) technology.
The qualification of cleanrooms and clean areas requires a high degree of know-how and use of suitable and adequately calibrated measuring and test equipment. Their execution must conform to the applicable standards and regulations. On the one hand, this is to make it possible to reproducibly identify cleanroom quality. On the other hand, it also is to help to pass on this standard to public authorities and customer
A cleanroom audit
- represents independent review of the normatively specified procedure for classifying a cleanroom
- is conducted by trained and experienced auditors of Quality Austria
- is documented by means a Certificate valid on an international scale
- quality assurance in the cleanroom, which ranges from planning via installation and operation to performance
- independent demonstration of quality/the level of production environments
- minimizing customer audits
- benchmark comparabilities in the production process
- marketing effect, e.g. our production is done in certified cleanrooms of Class 5 (acc. to EN ISO 14644/1)
Organizations active in the following fields:
- nano-technology and precision mechanics
- aerospace industry
- microelectronics, electrical engineering, surface treatment
- medical technology, hospitals
- genetic technology and bio-technology, pharmaceutical industry
- laser technology, glass fibre technology and PCB technology (PCB – Printed Circuit Boards)
- food sector
Identification and labelling of the particle purity in a cleanroom will be done according to the criteria of ISO 14644 and must include the following items.
- Classification Number, e.g. ISO Class 7
- the operating state to which the classification applies
- the considered particle size, e.g. 0.5μm or 5μm
There is a normative difference between cleanroom classes 1 (highest purity level) to classes 9. The basic requirement is to ensure and document the permanent conformity to the selected cleanroom class.
Critical parameters of cleanrooms are:
- air cleanliness, air exchange rate, air volumes
- choice of the adequate cleanroom class
- clothing in cleanrooms
- choice of suitable operating materials
- air filters, filter classes, mode of action of filters
- planning of sluices and access areas
ISO 9001, HACCP, ISO 14698, GMP, VDI 2083
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