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Pharmaceutical product production requires the setting up of cleanrooms and associated controlled environments in which we endeavour to control the concentration of airborne particles, the temperature, humidity and pressure.


A clean room is surrounded by its shell, which is a physical barrier made up of partitions, ceilings, doors and floors separating various (classified and/or unclassified) areas which, depending on the sector of activity, have to meet a certain number of design criteria or very specific performance requirements (mechanical performance, geometry, ergonomics, fire hazard properties, sound proofing, etc).

The following areas are to be found within the pharmaceutical production sector:

  • 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: Contamination by particulate contaminants, contamination by 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.

The standard NF EN ISO 14644 defines a cleanroom as being a "room in which the concentration of airborne particles is controlled and which is built and used in such a way as to minimise the introduction, production and retention of particles inside the room and in which other pertinent parameters such as temperature, humidity and pressure are controlled as necessary."

The pharmaceutical industry works in enclosures that mainly fall within level 2 and 3 containment classes (referred to as L2 and L3) and has its own recommendations including European GMPs (Good Manufacturing Practices) which stipulate the category of cleanliness to be achieved according to the activity in question, American GMPs, the FDA, the European Medicines Evaluation Agency (EMEA), etc.

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