Glossary

Silt Density Index

System Development Life Cycle

Scientific Data Management System

Sterile Drug Product

Standard Dimensional Ratio

A sizing system for polymer piping systems that relates wall thickness to pressure rating a defined by ISO.

Sodium Dodecyl Sulfate

Software Design Specification

An analytical separation technique that uses a charged gel environment through which molecules of varying sizes and electric charges migrate from one pole to the other. Unlike gel-filtration chromatography, larger molecules move more slowly than smaller molecules because migration rate is not dependent on diffusion into and out of particles.

Single Effect (still)

Standard Error

Surface point on which a seal is achieved.

When a knower organization evaluates a product or service, it often grants a seal of approval such as a certification mark, a degree, or a rating, which helps to determine the seller's reputation and provides assurance to consumers.

Location of process boundary created by components in contact (seal), having sufficient contact stress/load to create media or environmental isolation.

A weld used to obtain fluid tightness as opposed to mechanical strength.

Styrene-Ethylene-Butadiene-Styrene (block copolymer)

In an ELISA or other immunological assay system, the antibody that binds to the primary antibody. The secondary antibody is often conjugated with an enzyme such as alkaline phosphatase.

Level of containment that is external to and separate from primary containment.

Outer box/carton containing primary containers with IMP.

The passage of a molecule from the inside of a cell through a membrane into the periplasmic space, or the extracellular medium.

The ability to generate accurate and complete copies of records in both human-readable and electronic form suitable for inspection, review, and copying by FDA. Records must be protected to enable their accurate and ready retrieval through the records retention period.

(IEEE) The protection of computer hardware and software from accidental or malicious access, use, modification, destruction, or disclosure. Security also pertains to personnel, data, communications, and the physical protection of computer installations.