Resources
Glossary: B
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Bacterial Filtration Efficiency (BFE)
The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that are designed to provide protection. It is a measurement of a material’s resistance to penetration of bacteria.
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Bacterial retention testing
Bacterial retention testing is performed to validate that a filter can remove bacteria from a gas or solution. The test is usually performed using a standard organism, such as Brevundimonas diminuta at a minimum concentration of 107 Colony Forming Units/ml. Source: GMP Draft Annex 1…
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Barrier
A barrier is a physical partition that affords aseptic processing area (usually grade A) protection by separating it from the background environment. Such systems frequently use, in part or totally, the Barrier Technologies known as RABS or isolators. Source: EU GMP Annex 1…
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Bio-decontamination
Bio-decontamination is a process that eliminates viable bioburden via use of sporicidal chemical agents. Source: EU GMP Annex 1…
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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 (BPR)
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.Cleanroom Services
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