Particle: A particle can be defined as a substance with a certain size, either in liquid or solid state, or in both states. The particle size range defined by the US Federal 209E standard is from 0.001 micrometers to 1 micrometer. The ISO14644 standard defines particles as small particles with a specified physical boundary.
Particle concentration: The number of particles per unit volume of air.
Particle size: The maximum linear dimension visible to the naked eye when observing particles under a microscope, or the equivalent diameter detected by an automated detection instrument.
Ultrafine particles: Particles ranging from approximately 0.01 micrometers to the upper limit of the particle size detection range of a discrete particle counter.
GMP:
Good Manufacturing Practice for Pharmaceuticals. This is a series of regulations designed to ensure that the cleanliness, labeling, efficacy and composition of the products remain consistent throughout the production process. (This is a series of fundamental measures taken to ensure the absolute quality of pharmaceuticals.)
cGMP:
Current Good Manufacturing Practice for Pharmaceuticals.
Cleanroom: A room where the concentration of suspended particles is controlled at a certain level. Generally, this is achieved by controlling the ingress of particles, the formation of particles, and the retention of particles to control the cleanliness of the room. In many cases, the temperature, humidity, and pressure within the room also need to be controlled.
Clean area: A defined space where the concentration of suspended particles is controlled within a specified cleanliness level.
Idle cleanroom: All relevant facilities in the cleanroom have been installed and can be put into operation, but there are no production equipment or personnel in the room.
Static cleanroom: All relevant facilities in the cleanroom are in operation, the production equipment is installed and running, but there are no staff in the room.
Dynamic cleanroom: All facilities in the cleanroom are in normal operation, the equipment in the cleanroom is running normally, and the personnel are fulfilling their job responsibilities.
Cleanliness: The allowable statistical number of suspended particles larger than or equal to a certain particle size in a unit volume of the clean environment.
Unidirectional flow: An airflow that flows along parallel flow lines at a certain velocity, through a single path, and in a single direction.
Non-unidirectional flow: An airflow with multiple circulation paths or an airflow direction that is not parallel, not meeting the definition of unidirectional flow.
(Transferred from Cleanroom Information Network)
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