Brief glossary of cleanroom systems terminology
The most important abbreviations in the field of cleanroom technology – a small glossary of cleanroom technology explains what you need to know.
Diethylhexyl sebacate: Monodisperse aerosol, which is used to test air filters.
Dioctyl phthalate: Previously-used test aerosol, which also has harmful effects.
Food and Drug Administration: American approval and regulatory authority.
Good Manufacturing Practices. Statutory EU directive for the manufacture of pharmaceuticals.
High Efficiency Particulate Air filter
Standard for cleanrooms and related cleanroom areas. Sections 1 and 2 of the standard replace US federal standard 209, which was effective until November 2001.
Colony Forming Unit: Germs capable of multiplying, e.g. bacteria, fungi, yeasts.
Impurities from unwanted, generally harmful substances. The cleaning process for the abatement of contamination is referred to as decontamination.
Microorganisms are an important subclass of particles. Single celled microscopic organisms, which can reproduce by means of cell division under suitable conditions.
Most Penetrating Particle Size: The particle size, which penetrates the filter most easily.
Liquid or solid particles with defined physical boundaries.
Pharmaceutical Inspection Convention (global collaboration and information exchange of health authorities in the field of pharmaceutical production)
A room in which the concentration of airborne particles is controlled and maintained. It is operated in such a way, that the introduction, release and retention of particles is minimised. In addition to the particle count, the variables to be regulated are temperature, humidity and air pressure.
Standard Operation Procedures: Standardisation of procedures.
Ultra Low Penetration Air filter, U15-U
US federal standard 209
Recognised and internationally observed standard for the classification of air purity. Was replaced by DIN EN ISO 14644-1 in November 2001.