Resources
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Action Limit
An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation…
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Actuators
An actuator is a mechanical component that can move a mechanism or system. In…
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Adjustable height feet
Adjustable height feet are feet that can be adjusted to ensure a level system is created, even on uneven floors.
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Advisory Committee on Dangerous Pathogens
The Advisory Committee on Dangerous Pathogens’ (ACDP) role is to provide scientific advice on the risks to exposure to pathogens and risk assessment advice on transmissible spongiform encephalopathies (TSEs). ACDP is an expert committee of the Department of Health. Its work cuts across a number of organisations, including the Health…
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Air changes per hour
Air changes per hour or the air change rate is the amount of time a cleanroom can completely replace its air volume within an hour. The higher the air changes per hour, the more effective it will be at removing contamination, therefore achieving a…
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Air cleanliness
Air cleanliness is a generic term. With regards to cleanrooms, air cleanliness is usually measured by taking airborne particle counts with a particle counter. The cleaner the air, the higher class a cleanroom.
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Air Conditioning
Air conditioning to regulate temperature and humidity control should be considered as part of the full cleanroom HVAC solution. All controlled air needs to be appropriately blended in the ducting before introduction into the cleanroom through ceiling mounted HEPA fan filter units, to ensure temperature and humidity and cleanliness levels…
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Air differential
An air differential typically refers to the difference in air pressure between two points within a system or environment. This concept is commonly used in various fields such as HVAC (heating, ventilation, and air conditioning), automotive engineering, and aerodynamics. In HVAC systems, an air differential is often measured to ensure…
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Air handling units (AHU)
An AHU or Air Handling Unit is used to regulate air within an HVAC (heating, ventilating and air-conditioning) system. Due to the volumes of Air Changes required to achieve high levels of ISO14644 classification, Air Handling Unit (AHU) plant and equipment can be both costly and ineffective when trying to…
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Airborne particle counts
Airborne particle counts are an air sampling method, used to determine if a cleanroom is meeting the required particle concentration limits within its ISO 14644-1:2015 class parameters. They can be taken with a particle counter and will form part of a cleanroom validation check. They should also be taken regulary…
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Airborne particles
Airborne particles are sub-micron particles, which are invisible to the naked eye. As their mass is so low, they can hang suspended in the air and are very susceptible to turbulence. This airborne particulate can cause damage to sensitive processes, so a cleanroom uses air filtration which removes them from…
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Airlock
An airlock is an enclosed space with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an airlock is to preclude ingress of particle matter and microorganism contamination from a lesser controlled area. Source: EU GMP Annex 1 Types…
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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…Cleanroom Services
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