Glossary

Licenses and Inspections

(USP) Document physically attached directly to the packaging materials that are in direct contact with the excipient, drug substance, or drug product.

A display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of the Federal Food, Drug, and Cosmetic Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

(USP) Includes the label and the documents included with, but not attached to, the packaging materials that are in direct contact with the excipient, drug substance, or preparation (e.g. package insert).

The process of replacing a stable atom in a compound with a radioactive isotope of the same element to enable it to be detected by autoradiography or other techniques. Increasingly, radioactive labelling is being replaced by fluorescent labeling. The method is used to trace the path of the labeled compound through a biological or chemical system.

Unstable or unsteady; not fixed; characterized by adaptability to alteration or modification, i.e., relatively easily changed, as in cleavage of a molecule or molecular rearrangement in a compound or complex chemical material.

Provides status of personnel in an up-to-minute time frame. Includes time and attendance reporting, certification tracking, as well as the ability to track indirect activities, such as material preparation or tool room work as a basis for activity based costing. It may interact with resource allocation to determine optimal assignments.

A discontinuity in welding of tubing where, after a reflow or second weld pass has been made, the original joint has still not been consumed, leaving the weld joint with unfused edges on the inner surface.

Milk sugar, a disaccharide with one unit each of glucose and galactose.

Leukocyte Adhesion Deficiency

A graphical, problem oriented, programming language which replicates electronic switching blueprints.

Lowest Achievable Emission Rates

Laminar Air Flow

Limulus Amoebocyte Lysate

A material obtained by rupturing the cellular components of the blood of a horseshoe crab (Limulus Poliphemus). This material coagulates in the presence of LPS (lypopolysaccharides) and is a test used to quantitate bacterial endotoxins (pyrogens).

Low-Angle Laser Light-Scattering

(pl: lamellae) A double-membrane structure, plate or vesicle that is formed by two membranes lying parallel to each other.

Terrace-like fractures in the base metal with a basic orientation parallel to the wrought surface; caused by the high stress in the thickness direction that results from welding.

A workstation in which the unidirectional airflow characteristics predominate throughout the entire airspace with a minimum of eddies (turbulence) to jeopardize critical surfaces.

An organized flow field that can be described with streamlines. In order for laminar flow to be permissible, the viscous stresses must dominate over the fluid inertia stresses.

Non-turbulent fluid flow is usually considered laminar if the Reynolds number is less than 2000 in a pipe. Depending upon many possible varying conditions, the flow may be laminar at a Reynolds number as low as 1,200 or as high as 40,000; however, such conditions are not experienced in normal practice. In the pharmaceutical industry, this term incorrectly refers to the air discharge of a clean air bench or wall.

Elongated defects in a finished metal product, resulting from the rolling of a welded or other part containing a blowhole. Actually, the blowhole is stretched out in the direction of rolling.