Glossary Terms (Simple List)
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Area
Measured surface area of a flat projection of a particle.(TR85)
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Area Disinfection
Disinfection of floors, walls, ceilings, and other surfaces. (TR70)
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As Low as Reasonably Practicable (ALARP)
The ability to reduce risk. ALARP has two facets: Technical and Economic. Technical practicability refers to the ability to reduce risk regardless of cost. Economic practicability refers to the ability to reduce risk without making the product too costly to produce. (TR54) (TR54-2) (TR54-3)
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Aseptic (Asepsis)
Free from disease-producing microorganisms. (TR28)
Free from disease-producing microorganisms. An operation performed in a controlled environment designed to prevent contamination through the introduction of microorganisms. (TR26)
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Aseptic Filling
The part of aseptic processing where a pre- sterilized product is filled and/or packaged into sterile containers and closed. (TR22) (TR28) (TR62) (TR13)
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Aseptic Process
A process in which sterile materials are handled in an environment in which the air supply, materials, equipment and personnel are controlled to prevent microbial and particulate contamination. (TR44) (TR51)
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Aseptic Processing
Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69)
Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)
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Aseptic Processing Area (APA)
Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)
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Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)
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Aspect Ratio
The length of a particle or fiber divided by its width. (TR85)