Glossary

C

Cleanroom Classification

Cleanroom classification is a method of assessing the level of air cleanliness against a specification for a cleanroom or clean air equipment by measuring the total particle concentration. Source: EU GMP Annex 1 For more information on ISO and GMP classifications and their corresponding particle limits, take a look at…

C

Cleanroom extension

A cleanroom extension takes place when a cleanroom may need to be extended to allow organisations to react to increased market demand. Modular cleanrooms are easily extended as modules can be added on, so investment is future-proofed.

C

Cleanroom Qualification

Cleanroom qualification is a method of assessing the level of compliance of a classified cleanroom or clean air equipment with its intended use. Source: EU GMP Annex 1 For more information of the cleanroom qualification services Angstrom Technology offer, see our services page on cleanroom validation or our knoweldge…

C

Cleanroom relocation

Cleanroom relocation involves moving your cleanroom from one space to another. There are a number of reasons for which a cleanroom may need to be relocated. They may need to relocate to larger premises, or a project may finish and the cleanroom needs to be repurposed in another part of…

C

Closed system

A closed system is a system in which the product is not exposed to the surrounding environment. For example, this can be achieved by the use of bulk product holders (such as tanks or bags) that are connected to each other by pipes or tubes as a system, and where…

C

CMC Pharmaceuticals

CMC is an acronym for Chemistry Manufacturing and Controls, which are stages of the drug development life cycle.

C

Colony Forming Unit (cfu)

A colony forming unit is a microbiological term that describes a single detectable colony that originates from one or more microorganisms. Colony forming units are typically expressed as CFU per ml for liquid samples, CFU per m3 for air sample and CFU per sample for samples captured on solid medium…

C

Composite

A composite is a material made up of 2 or more component parts to create a material with specialist properties to suit varying applications. I.e. resin and fibre may be used to create a durable cleanroom worktop resistant to cleaning chemicals. The aerospace and automotive industries typically use resin and…

C

Controlled Non Classified (CNC) area

A controlled non classified area is an area where HVAC systems are specifically designed to reduce airborne contaminants below the level of the ambient environment and both temperature and relative humidity are controlled more tightly than in the ambient environment. Source: ISPE…

C

Coved floor

A coved floor is when the floor is extended at the edges to be applied up the wall, creating a curved surface from wall to floor. A coved finish to flooring creates a smooth and easy to clean system – one of the hallmarks of GMP design. Usually coved onto…

C

Critical surfaces

Critical surfaces are surfaces that may come directly into contact with, or directly affect, a sterile product or its containers or closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is maintained throughout processing. Source: EU GMP Annex 1…

C

Critical Zone

A critical zone is a location within the aseptic processing area in which product and critical surfaces are exposed to the environment. Source: EU GMP Annex 1…