Glossary
Bacterial retention testing
This test is performed to validate that a filter can remove bacteria from a…
Barrier
A physical partition that affords aseptic processing area (grade A) protection by partially separating…
Bioburden
Bioburden is the number of bacteria living on an un-sterilised surface. GMP Draft Annex…
Biocidal Products Regulation (BPR)
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market…
Biocide
A biocide is a disinfectant with a broad spectrum of activity, especially against bacteria…
Biological Indicator (BI)
A population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closure)…
Blow-Fill-Seal (BFS)
Blow-Fill-Seal (BFS) technology is a pharmaceutical filling process in which containers are formed from…
Breakout Panel
To satisfy Health and Safety regulations and provide a convenient and quick escape route…
CFM
Change Area
Often a change room operates at a lower classification and pressure than the main…
CIP
Clean in Place products and processes – Clean-in-place is a method of cleaning the…
Clean Area
An area with defined particle and microbiological cleanliness standards. Source: GMP Draft Annex 1