Glossary

(ANSI) To determine whether a transcription of data or other operation has been accomplished accurately.

To check the results of data entry; e.g., keypunching.

To prove to be true by demonstration.

An established cell line derived from the kidney of the African green monkey.

Victorian Electronic Records Strategy (Australia)

An initial release or a complete re-release of a software item or software element.

A unique identifier used to identify software items and the related software documentation which are subject to configuration control.

A classification of ICs [chips] based on their size as expressed by the number of circuits or logic gates they contain. A VLSI IC contains 100,000 to 1,000,000 transistors.

A temperature control method consisting of a double wall outside the main vessel wall. Liquid or steam flows through the jacket to heat (or cool) the fluid in the vessel. Because biopharmaceutical products are so sensitive and vessel jackets can cause uneven heating (hot or cold spots), shell-and-tube or plate-and-frame heat exchangers are more common in biopharmaceutical production systems.

Referring to pharmaceuticals or biologicals intended for animal use. Historically veterinary products were made by less than “Good Manufacturing Products”. Today, however, the GMPs refer to both human and veterinary products.

Variable Frequency Drive

Vaporized Hydrogen Peroxide

Video Home System

Life and health, ability to grow and reproduce; a measure of the proportion of live cells in a population.

Assay of the number or percent of living cells or plants in a population that have been given a specific treatment; such as ascertaining cell viability after cryopreservation treatment, or for seeds.

As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary of Health and Human Services may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.

Living.

Capable of living and reproducing. Thus, nothing is sterile as long as it contains even a single viable organism.

Particle that consists of, or supports, one or more live microorganisms. ISO 14698-1, ISO 14698-2.

Particle that consists of, or supports, one or more live microorganisms.

One or more viable particles which are enumerated as a single unit. ISO 14698-1, ISO 14698-2NOTE: When viable units are enumerated as colonies on agar media, it is common usage to name them colony forming units (CFU). One CFU might consist of one or more VU.

A final container for a parenteral or diagnostic product. Sealed with a rubber closure and over-seal. Generally required to be class I borosilicate glass.

Standard method for measuring the hardness of metals, particularly those with extremely hard surfaces; the surface is subjected to a standard pressure for a standard length of time by means of a pyramid shaped diamond. The diagonal of the resulting indention is measured under a microscope and the Vickers Hardness value read from a conversion table.

Vocabulaire International de Metrologie/International Vocabulary of Metrology

Vacuum Insulated Panel