DEHSDiethylhexyl sebacate: Monodisperse aerosol, which is used to test air filters.
DOPDioctyl phthalate: Previously-used test aerosol, which also has harmful effects.
FDAFood and Drug Administration: American approval and regulatory authority.
GMPGood Manufacturing Practices. Statutory EU directive for the manufacture of pharmaceuticals.
HEPAHigh Efficiency Particulate Air filter
ISO 14644Standard for cleanrooms and related cleanroom areas. Sections 1 and 2 of the standard replace US federal standard 209, which was effective until November 2001.
CFUColony Forming Unit: Germs capable of multiplying, e.g. bacteria, fungi, yeasts.
ContaminationImpurities from unwanted, generally harmful substances. The cleaning process for the abatement of contamination is referred to as decontamination.
MPPSMost Penetrating Particle Size: The particle size, which penetrates the filter most easily.
ParticlesLiquid or solid particles with defined physical boundaries.
PICPharmaceutical Inspection Convention (global collaboration and information exchange of health authorities in the field of pharmaceutical production)
CleanroomA 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.
SOPStandard Operation Procedures: Standardisation of procedures.
ULPAUltra Low Penetration Air filter, U15-U
US federal standard 209Recognised and internationally observed standard for the classification of air purity. Was replaced by DIN EN ISO 14644-1 in November 2001.
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