Glossary

Any particulate matter, gas, or combination thereof, other than water vapor or natural air.

Rate of air exchange expressed as number of air changes per unit time and calculated by dividing the volume of air delivered in the unit of time by the volume of the space.

Schematically shows rooms and zones served by an air handler, with air balance requirements, and often room pressures.

The sampling for and measuring of contaminants in the air.

Air separation plants take atmospheric air and, through processes of purification, cleaning, compression, cooling, liquefaction and distillation, separate the air into three gases – oxygen, nitrogen and argon.

Meters to measure and indicate the force and speed of airflow. Meters may use a variety of probes for measuring near HEPA filters and at right angles. Monitors check and record air velocity.

Presence in the atmosphere of a cleanroom or controlled environment of molecular (chemical, non-particulate) substances in the gaseous or vapor state that may have a deleterious effect on the product, process or equipment in the cleanroom or controlled environment.NOTE: This definition does not include macromolecules of biological origin that are judged to be particles.

Solid or liquid object suspended in air, viable or non-viable, sized between 1nm and 100 µm.NOTE: For the purpose of ISO 14644-3.

Statistically allowable number of particles equal to, or larger than 0.5 micrometers in size per cubic foot of air.

Release of any chemical into the air.

Based on the AFD, it shows HVAC instrumentation and controls, with critical GMP components highlighted.

Using chemical smoke or fog to visualize flow patterns in a clean room or clean space

A cylindrical fermentation vessel in which the cells are mixed by air introduced at the base of the vessel and that rises through the column of culture medium. The cell suspension circulates around the column as a consequence of the gradient of air bubbles in different parts of the reactor.

A room or space designed to act as a means of transfer between areas of different air classification or quality.

Intermediate room or area that is normally ventilated, and used to minimize the transfer of airborne contamination from one area to another. A room or space designed to act as a means of transfer between areas of different air classification or quality.

A room or space designed to act as a means of segregating areas of different air classification or quality. It may contain a method to remove particulate contamination from clean room garments as personnel pass through, and usually includes HEPA filtered air supply and interlocking doors. Airlocks pressure will “float” between those of the spaces being protected. With all doors closed, the airlock pressure will be somewhere between that of the highest adjoining room and that of the lowest adjoining room as air flows through it from room to room. “Ventilated airlocks” are in neutral ducted air balance (supply CFM = return CFM).

An enclosed space with two or more doors and which is interposed between two or more rooms, e.g., of differing class of cleanliness, for the purpose of controlling the air flow between those rooms when they need to be entered. An airlock is designed for and used by either people or goods.

American Institute of Steel Construction

American Iron and Steel Institute

American Institute of Timber Construction

also know as

Alanine, one of over 20 naturally occurring amino acids.

Audible or visual signals used to warn of unacceptable conditions at monitored sites. They may be buzzers, horns, speakers, bells, or warning lights. They can be Advisory, Alert, or Action alarms. The first two are for operation and maintenance information, to alert of abnormal situations that do not compromise product SISPQ. The Action alarm is for GMP records, indicating that product SISPQ may have been compromised, but Alert alarms are also usually recorded.