Glossary

An acronym for FORmula TRANslator, the first widely used high-level programming language. Intended primarily for use in solving technical problems in mathematics, engineering, and science.

An objective and quantitative method of determining filter integrity. A test in which the filter is wetted and a predetermined constant air pressure is applied. A measurement of pure diffusional airflow through the wetted membrane is made. If the diffusional airflow across the membrane is below the maximum allowable value given then the filter is acceptable.

Occurs when gelatinous coatings, colloidal masses, or dense bacterial growth form a compacted crust on membrane or filter surfaces which blocks further flow.

A type II restriction endonuclease that binds (and subsequently cleaves) DNA at sites that contain a sequence of four nucleotide pairs that is uniquely recognized by that enzyme. Because any sequence of four bases occurs more frequently by chance than any sequence of six bases, four-base cutters cleave more frequently than do six-base cutters. Thus, four-base cutters create smaller fragments than six-base cutters.

Facility of the Year Committee (ISPE term)

Fluorine Rubber (Viton®)

Functional Performance Test

Federal Register

The portion of a mixture that contains a particular molecular species.

Any of several precipitation or phase-separation methods used to determine the molecular weight distribution of polymers, based on the tendency of polymers of high molecular weight to be less soluble than those of low weight.

The range of molecular sizes that can fit (or diffuse) into the pores of a gel filtration chromatography medium particle.

After Down syndrome, the second most frequent genetic cause of mental retardation. The disorder is one of a group of diseases that results from an unusual kind of mutation: a repeating sequence of three letters of the DNA code, called a triplet repeat or trinucleotide repeat. In Fragile X, the repeating triplet is CGG, cytosine-guanine-guanine, in a gene on the X chromosome. The larger the number of repeats they possess, the more likely patients are to be seriously impaired. People who possess just a few repeats are carriers but often not affected.

Functionality-related Characteristics

The process of drying a tissue or an organ in a frozen state under vacuum. Tissues are freeze-dried to measure their dry weight or to preserve them for future analysis. Freeze-drying is the standard way of preserving micro-organisms for long periods of time.

Freezer indicates a place in which the temperature is maintained thermostatically between -25º and -10ºC (-13º and 14ºF). Note: the freezing point is defined as the temperature at which a liquid substance turns to a solid. The term frozen is applied to the solid product.

Any adverse event, which by its frequency (even though it may be individually not serious), significantly reduces the overall therapeutic benefits of the intervention, requires reporting to the Committee. Many times this reporting presents itself in the form of an amendment to the Investigational Drug Brochure and can often result in revision to the consent.

Updating that occurs at specified intervals not exceeding 60 minutes during operation. ISO 14644-2.

Friend Murine Leukemia Virus strain

Increased extent of effort expanded at the start of a project to initiate, define, and scope a project.

Fiber-Reinforced Plastic

Fiberglass-Reinforced Plastic

Functional Requirement Specification

Functional Specification