Glossary
Critical Area
An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and…
Critical surfaces
Surfaces that may come into contact with, or directly affect, a sterilized product or…
Cumulative particle counts
D value
De-centralised air handling
Through a de-centralised air handling approach, the same results can be delivered as with…
De-ionised water (DI water of DIW)
Deionized water is water that has had almost all of its mineral ions removed, however…
Decontamination
A process that eliminates viable bioburden via use of chemical agents. Source: GMP Draft…
Delta (∆) column of particle counts
Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative…
Depyrogenation
A process used to destroy or remove pyrogens (e.g. endotoxin). Source: GMP Draft Annex…
Dew point
Dew point (dp) is the temperature that a volume of air reaches when it…
Dewpoint vs humidity
Dewpoint (dp) is the temperature that a volume of air reaches when it becomes…
Differential particle counts
Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative…