Clean room

Definition according to ISO 14644-6 (September 2007) §2.33:

"Room in which the concentration of particles suspended in the air is managed, and that is built and used in a manner that minimises the introduction, production and retention of particles within the room, and in which other relevant parameters, such as temperature, humidity and pressure are managed as required."

Business sectors

Clean rooms are employed in various business sectors:

  • pharmaceutical, biotechnology, medical device and cosmetics industries
  • micro-electronics industries (semi-conductors, space, nanotechnologies, etc.)
  • leading-edge technology industries: photovoltaics, research and development laboratories, etc.
  • health care: central pharmaceutical stores, the Etablissement Fran├žais du Sang (EFS, the French blood bank authority) 
  • agricultural foodstuff industries

Regulations

ISO 14644-5 § B6 (2004)

It is necessary to perform the final treatment and preparation of clean room clothing under clean room conditions compatible with the clean room standards in which the garments will be used.

BPF BO n°2009/9 bis LD1 § 41 to 45

41. The replacement and washing of garments must be done in accordance with a written procedure designed to minimise the contamination of clothes worn in controlled-atmosphere areas, and to minimise the introduction of contaminants in such areas.

42. The garments and their quality must be suitable for the production work being carried out in the working areas, and the classifications of the said areas. They must be worn so as to protect the produce from contamination.
 
43. The garments required for each class are described below:
 
Class D: Hair and, where appropriate, beards must be covered. Normal protective clothing and shoes or overshoes must be worn. Appropriate measures must be taken to prevent any contamination coming from outside the controlled-atmosphere area.
 
Class C: Hair and, where appropriate, beards must be covered. An outfit must be worn, consisting of a jacket and trousers, or overalls, tightened at the wrists and with a high collar, together with suitable shoes or overshoes. The fabric must release practically no fibres or particles.
 
Class A/B: a hood must entirely enclose hair and, where appropriate, beards and moustaches. This hood must be joined to the collar of the jacket. A mask must cover the face to prevent the projection of droplets. Sterilised and non-powdered rubber or plastic gloves and sterilized or disinfected boots must be worn. The bottom of the trouser legs must be tightened against the boots, and the sleeves of the jacket must be tightened against the gloves. This protective clothing must release practically no fibres or particles, and must contain the particles released by the wearer.
 
44. Personal clothes must not be taken into changing rooms leading to premises of classes B and C. Clean and sterile protective clothing (effectively sterilised or disinfected) must be worn by every worker in areas of classes A/B, during each work shift. Gloves must be regularly disinfected during operations. Masks and gloves must be changed at least every work shift.
 
45. Clothing in controlled-atmosphere areas must be cleaned and handled in such a way that they do not become charged with contaminants that might be released at a subsequent occasion. These operations must be performed according to written procedures. It is desirable to have a cleaning installation reserved only for these garments.
Some unsuitable treatments can damage the fibres and increase the risk of releasing particles.

 

Your needs

There are 3 categories of need:

  • prevention of particle contamination
  • prevention of biological contamination
  • control over static electricity discharges

To maintain the classification of your clean room, it is necessary to always control the sources of biological and particle contamination.

One of the sources of contamination is the clean room worker. Garments must:

  • contain the contamination from workers while remaining comfortable and ventilating
  • not themselves be a source of contamination.

For this, clothing has to be maintained under clean room conditions, using a special process (particle decontamination and sterilisation if necessary).

Choice of clothing and treatment


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