Resources
Glossary
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Alert Level
An alert level is an established relevant measure (e.g. microbial, or airborne particle levels) giving early warning of potential drift from normal operating conditions and validated state, which does not necessarily give grounds for corrective action but triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are…
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ANVISA
The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.
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Approved Code of Practise (ACOPs)
The Approved Code of Practise (ACOPs) describe preferred or recommended methods that can be used (or standards to be met) to comply with regulations and the duties imposed by the Health and Safety at Work etc Act. The legal status of guidance and ACOPs is given below and will appear…
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As-built cleanroom
An as-built cleanrrom is a cleanroom that is complete, functional and ready for operation, but without the equipment and personnel inside. Testing a cleanroom as-built, reflects the quality of the supply air.
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Asepsis
A state of control attained by using an aseptic work area and performing activities…
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Aseptic Preparation/Processing
Aseptic preparation/processing is the handling of sterile product, containers and/or devices in a controlled environment in which the air supply, materials and personnel are regulated to prevent microbial, endotoxin/pyrogen and particle contamination. Source: EU GMP Annex 1…
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Assisted build
An assisted build, often used for international cleanroom builds, is where a small number of people from the cleanroom company would oversee a team of subcontractors provided by the client, who would conduct the cleanroom build. A major benefit of an assisted build is that it can keep costs down,…
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At-rest cleanroom
The definition of “at rest” state is the condition whereby the installation of all the utilities is complete including any functioning HVAC, with the main manufacturing equipment installed as specified but not operating and without personnel present in the room. Source: EU GMP Annex 1…
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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…Cleanroom Services
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