Glossary Terms (Simple List)
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Clean(liness)
The measurement for the level of particulates, microbes, or other extraneous substances on an item or surface. (TR 70)
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Cleaning
The process of removing foulants from the membrane structure during normal processing, either through physical or chemical means. (TR13) (TR15)
The removal of adherent visible soil from the surfaces, crevices, serrations, joints, and lumens of instruments, and from devices and equipment, by a manual or mechanical process that prepares the items for safe handling and/or further decontamination. The cleaning process should leave surfaces that are visibly free from foreign material. (TR51)
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Cleaning Agent
The solution or solvent used in the washing step of a cleaning process. Examples of cleaning agents are water, organic solvent, commodity chemical diluted in water, and formulated detergent diluted in water. (TR29) (TR70)
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Cleaning Procedure
The documentation that assures any product and process-related material introduced into equipment as part of the manufacturing process stream is removed and the equipment is adequately stored. (TR29)
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Cleaning Process
A process that is used to remove any product, process-related material and environmental contaminant introduced into equipment as part of the manufacturing stream. (TR29)(TR49)
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Cleaning Validation
Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)
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Cleaning Verification
A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)
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Cleanroom
A room designed, maintained, and controlled to prevent particle and microbiological contamination of a drug product or medical device. A cleanroom is assigned and reproducibly meets an appropriate air cleanliness classification. (TR13)
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Clinical Protocol
A document, together with any amendments to it, that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. (TR63)
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Clinical Trial Material (CTM)
A drug or combination of drugs and/or excipients that are produced with the intent that it be used in a clinical trial, or that is released or otherwise authorized for use in such. This could, subject to appropriate regulatory approval, be an experimental medicine, a product with marketing authorization used in a clinical trial within or beyond the approved indication and/or any placebo articles produced for use in a clinical trial. (TR63)