Resources

Glossary

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Bioburden

Bioburden is the number of bacteria living on an un-sterilised surface. GMP Draft Annex…

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Biocidal Products Regulation

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation…
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Biocide

A biocide is a disinfectant with a broad spectrum of activity, especially against bacteria and fungi. Microbial contamination could consist of bacteria, fungi, viruses or bacterial spores. Most biocides are not effective against bacterial spores, which pose a particular threat as they are so difficult to kill, and can lay dormant…
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Biological Indicator (BI)

A biological indicator is the population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closure) and placed within a steriliser or load or room locations to determine the sterilisation or disinfection cycle efficacy of a physical or chemical process. The challenge microorganism is selected and validated based…
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Blow-Fill-Seal (BFS)

A blow fill seal is a technology in which containers are formed from a thermoplastic granulate, filled with product, and then sealed in a continuous, integrated, automatic operation. The two most common types of BFS machines are the Shuttle type (with Parison cut) and the Rotary type (Closed Parison). Source:…
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Breakout Panel

A breakout panel is required to satisfy Health and Safety regulations and provide a convenient and quick escape route from the cleanroom in the event of an emergency. Breakout panels should be clearly marked and need to be able to be removed in seconds to allow exit.
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CFM

CFM is an abbreviation for cubic feet per minute (cu ft/min). When used in the context of a particle counter’s flow rate, it is a measurement of the velocity at which air flows into the sample probe. For example, a flow rate of 0.1 CFM means the particle counter will…
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Change Area

A change area is an area with defined particle and microbiological cleanliness standards usually containing a number of joined cleanrooms. Source: EU GMP Annex 1 A cleanroom change room, or gowning area, is a room in which operatives can don their cleanroom garments prior to entering the main cleanroom zone.
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Clean Area

A clean area is an area with defined particle and microbiological cleanliness standards. Source: GMP Draft Annex 1…
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Clean In Place (CIP)

Clean in Place (CIP) products and processes – Clean-in-place is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly.
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Cleaning

The removal of soils and residues (including biofilms) through use of a detergent. This…

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Cleanroom

A cleanroom is a “room within which the number concentration of airborne particles is…

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