You are here : Home Page | Your sector | Biotechnology




The biotechnology sector requires the setting-up of cleanrooms and associated controlled environments in which we can control the concentration of airborne particles, as well as temperature, humidity and pressure.


This sector is involved in multiple activities: safety laboratories, R&D laboratories, a production unit, bio-exclusion zone, animal supply facilities, etc.

The cleanroom is protected by a shell, a physical barrier made up of partitions, ceilings, doors and floors separating various (classified and/or unclassified) areas which have to meet a certain number of design criteria or very specific performance requirements (mechanical performance, geometry, ergonomics, fire hazard properties, sound proofing, etc).

Cleanrooms for the animal supply facilities are established according to the classification of risk zones from class 1 (not likely to cause illness in humans) to class 4 (likely to cause serious illness in humans and with a risk of environmental contamination). The animal supply facilities for biotechnology mainly operate in enclosures classified in containment classes A1 to A4.

R&D laboratories mainly operate in enclosures classified in containment classes 2, 3 and 4 (known as L2, L3 and L4).

In appendix B of NF S 90-351, four levels, 1 to 4, are proposed in relation to the technical performance of a facility, with level 1 being the lowest and level 4 the highest. Risk control, mainly at a microbiological level, applies to level 2 to 4 areas.

In the biotechnology sector, the following areas are identified:

  • A controlled atmosphere where particulate and microbial contamination is controlled in order to prevent the introduction and proliferation of substances that might contaminate the environment;
  • A containment area in which efforts are made to adjust the air treatment and filtration systems so that the environment in the room prevents biological agents causing contamination outside of the room;
  • A containment area with a controlled atmosphere in which efforts are made to comply with the combined requirements of a controlled atmosphere and a containment area.

Three main contamination risk types may be identified: particulate contaminants, biological agents and cross-contamination.

For all cleanroom and associated controlled environment activities, the international benchmark standard is NF EN ISO 14644. This is supplemented by the standard NF EN ISO 14698 which deals with biocontamination control.

see also