Glossary Terms (Simple List)
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ISO 8
Environmental operating conditions defined in ISO 14644-1, “Cleanrooms and associated controlled environments.” Note: For total particulates, ISO 8 approximates Class 100,000 from the now obsolete Federal Standard 209. (TR62)
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ISO/IEC
International Organization for Standardization/International Electrotechnical Commision. (TR52)
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Isolated Intermediate
An intermediate that is obtained as the product after workup of a purification step in the process scheme for the drug substance. The isolation or purification procedure should be part of the validated process. An aliquot of a product that is worked up and/or purified for purposes of characterization does not constitute an isolated intermediate. (TR38)
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Isolates
Microorganisms that are recovered from a facility. (TR70)
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Isolator
An industry-specific separative enclosure. (TR51)
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Isolator, Closed
A decontaminated unit meeting ISO 5 conditions that provides uncompromised, continuous, isolation of its interior from the surrounding environment. Any air exchange with the surrounding environment takes place only through microbially retentive filters. (TR22) (TR62) (TR13)
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Isolator, Open
A decontaminated unit meeting ISO 5 conditions that provides uncompromised, continuous, isolation of its interior from the surrounding environment. It may transfer air directly to the surrounding environment through openings (e.g., “mouse holes”) that preclude the ingress of microbial contamination. (TR13) (TR22) (TR62)
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ISTA: International Safe Transit Association
World-wide organization that supports its membership in designing and developing effective pre-shipment packaging performance standards, guides, and best practices for product distribution. (TR39)
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Justification
Reports containing scientific data and expert professional judgment to substantiate decisions. (TR38)
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Key Attributes
A subset of the characteristics of the drug which are determined to be most important to quality. (TR63)