Glossary

Information Security Management

Information Security Management Service

International Organization for Standardization

The Institute of Environmental Sciences and Technology (IEST) is the Secretariat for Technical Committee 209 of the International Standards Organization (ISO/TC 209), charged with writing a series of international standards for cleanrooms and associated controlled environments.International Cleanrooms and Associated Controlled Environments Standard ISO 14644 consists of the following parts:1.14644-1: Cleanrooms and associated controlled environments – Part 1: Classification and cleanliness2.14644-2: Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-13.14644-3: Cleanrooms and associated controlled environments – Part 3: Test methods4.14644-4: Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up5.14644-5: Cleanrooms and associated controlled environments – Part 5: Operations6.14644-6: Cleanrooms and associated controlled environments – Part 6: Vocabulary7.14644-7: Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)8.14644-8: Cleanrooms and associated controlled environments – Part 8: classification of airborne molecular contaminationInternational Cleanrooms and Associated Controlled Environments Standard ISO 14698 consists of the following parts:1.14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods2.14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data

Level (or process of specifying or determining the level) of airborne particulate cleanliness applicable to a cleanroom or clean zone, expressed in terms of an ISO Class N, which represents maximum allowable concentrations (in particles per cubic meter of air) for considered sizes of particles.

Sampling condition in which the direction of the airflow into the sample probe inlet is the same as that of the unidirectional airflow being sampled. ISO 14644-3.

International Organization for Standardization, Reference Materials Committee

The pH level above which the substance would act as a base and below which it would act as an acid. A solution of proteins or amino acids has its minimum conductivity and viscosity at the isoelectric point. The pI is a pH level established as a value for a given substance; for example, the pI of gelatin is pH 4.7.

One of the several forms that a given enzyme can take. The forms may differ in certain physical properties, but function similarly as biocatalysts.

A member of a family of closely related proteins that have some amino acid sequences in common and some different.

Sexual reproduction involving the production fusion of gametes that are similar in size and structure.

Of the same genotype.

Sampling condition in which the mean velocity of the air entering the sample probe inlet is the same as the mean velocity of the unidirectional airflow at that location. ISO 14644-3.

A leaktight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both. A basic enclosure consists of a shell, viewing window, glove/sleeve assemblies, supply and exhaust filters, light (s), gauge (s), Input and Output openings (equipment door airlocks, Rapid Transfer Ports (RTPs), etc.), and various other penetrations. There are two types of isolators:1.Closed Isolators – Isolators operated as closed systems do not exchange unfiltered air or contaminants with adjacent environments. Their ability to operate without personnel access to the critical zone makes isolators capable of levels of separation between the internal and external environment unattainable with other technologies. Because the effectiveness of this separation, closed isolators are ideally suited for application in the preparation of sterile and/or toxic material. Aseptic and Containment isolators are two types of closed isolators.2.Open Isolators – Open isolators differ from closed isolators in that they are designed to allow for the continuous or semi-continuous egress of materials during operation, while maintaining a level of protection over the internal environment. Open isolators are decontaminated while closed, and then opened during manufacturing. Open isolators typically are used for the aseptic filling of finished pharmaceuticals.NOTE: Containment, barrier isolation and isolation all refer to the same technology, which is enclosing an environment. In the interest of clarifying the existing confusion between the terms “isolators” and “barriers”, and providing authoritative implementation and validation of isolation technology, the Parenteral Drug Association (PDA) published in October 2000 the Draft for Technical Report No. 34 “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products”.

Leaktight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both.

A decontaminated unit meeting Grade 5 conditions that provides uncompromised, continuous, isolation of its interior from the surrounding environment. Isolators can be “open” or ‘closed”.• Isolator, ClosedAn isolator that may exchange air with the surrounding environment only through microbially retentive filters.• Isolator, OpenAn isolator that transfers air directly to the surrounding environment through openings (e.g., “mouseholes”) that preclude the ingress of microbial contamination.

A leak tight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both. A basic enclosure consists of a shell, viewing window, glove/sleeves assemblies, supply and exhaust filters, light(s), gauge(s), Input and Output openings (equipment door airlocks, Rapid Transfer ports (RTPs), etc.), and various other penetrations.

Any of a class of enzymes that catalyse the re-arrangement of the atoms within a molecule, thereby converting one isomer into another.

The conversion of a chemical with a given molecular formula to another compound with the same molecular formula but a different molecular structure, such as from a straight-chain to a branched-chain hydrocarbon or an alicyclic to an aromatic hydrocarbon. Examples include the isomerization of ethylene oxide to acetaldehyde (both C2H4O) and butane to isobutene (both C4H10).

Describes molecules that have the same buoyant density in Ultracentrifugation. Molecules of differing densities form different regions in equilibrium within a medium.

System condition in which the temperature remains constant.

Isotonic literally translates to equal tension. Isotonic solutions involve no net movement of molecules across non-perfect biological membranes. Solutions remaining in osmotic equilibrium with respect to a particular biological membrane are said to be isotonic. This is different to iso-osmotic solutions which involve no net movement of molecules when separated by a perfect semi-permeable membrane.

A term applied to either of two or more nuclides that are chemically identical yet differ in atomic weight, since their nuclei contain different numbers of neutrons; many are radioactive (radioisotopes).

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International Society for Pharmaceutical Engineering