Brief glossary of cleanroom systems terminology

DEHS

Diethylhexyl sebacate: Monodisperse aerosol, which is used to test air filters.

DOP

Dioctyl phthalate: Previously-used test aerosol, which also has harmful effects.

FDA

Food and Drug Administration: American approval and regulatory authority.

GMP

Good Manufacturing Practices. Statutory EU directive for the manufacture of pharmaceuticals.

HEPA

High Efficiency Particulate Air filter

ISO 14644

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.

CFU

Colony Forming Unit: Germs capable of multiplying, e.g. bacteria, fungi, yeasts.

Contamination

Impurities from unwanted, generally harmful substances. The cleaning process for the abatement of contamination is referred to as decontamination.

Microorganisms

Microorganisms are an important subclass of particles. Single celled microscopic organisms, which can reproduce by means of cell division under suitable conditions.

MPPS

Most Penetrating Particle Size: The particle size, which penetrates the filter most easily.

Particles

Liquid or solid particles with defined physical boundaries.

PIC

Pharmaceutical Inspection Convention (global collaboration and information exchange of health authorities in the field of pharmaceutical production)

Cleanroom

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.

SOP

Standard Operation Procedures: Standardisation of procedures.

ULPA

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.