Glossary

Underwriters Laboratories Inc. (UL) is a private, not-for-profit, product safety testing and certification organization. Founded in 1894, UL tests more than eighteen thousand different products for more than fifty thousand customers. It operates testing centers and has customers throughout the world. On a voluntary basis, manufacturers submit products to UL for testing and safety certification. There are no laws specifying that a UL mark must be used. (In the United States, many municipalities have laws, codes, or regulations that require a product to be tested by a nationally recognized testing laboratory before it can be sold in the area, but not necessarily by UL, so UL does not have a monopoly). UL successfully ensures high-quality standards in the fields of electrical products, fire suppression devices, automotive equipment, and much more. UL even certifies the electrical and mechanical aspects of medical devices. The success of UL in these fields suggests that UL and similar organizations might also ensure safe and high-quality drugs.

An unexpected adverse event is any adverse experience that is not identified by nature, severity or frequency in the current investigator brochure or lay summary/consent.

A form of protein degradation in which the three-dimensional structure of a molecule unravels to something that more closely resembles a basic chain of amino acids.

UN Global Compact

Describing tissues, organs or organisms consisting of a single cell.

(ICH Q3B (R2)) A degradation product for which a structural characterization has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time).

(ICH Q3A (R2)) An impurity for which a structural characterization has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time).

(ICH Q6A) An impurity which is defined solely by qualitative analytical properties, (e.g., chromatographic retention time).

Controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately parallel air streamlines.

Controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately parallel streamlines. ISO 14644-4.NOTE: This type of airflow results in a directed transport of particles from the clean zone.

Unidirectional airflow pattern in which the point-to-point readings of velocities are within the defined percentage of the average airflow velocity. ISO 14644-3.

The most widely adopted model building code in the United States is a performance based document meeting the needs of government units charged with the enforcement of building regulations.

The premier model fire code in the United States sets forth provisions necessary for fire prevention and fire protection. Published by the International Fire Code Institute (IFCI) and endorsed by the Western Fire Chiefs Association, the International Association of Fire Chiefs, and the International Conference of Building Officials (ICBO), it contains code provisions compatible with the Uniform Building Code, and standards referenced from the code provisions.

A document that provides a complete set of requirements for the design, construction, installation, and maintenance of heating, ventilating, cooling and refrigeration systems; incinerators and other heat-producing appliances.

A code dedicated to intelligent community development and to the benefit of the public welfare by providing a means of promoting uniformity in zoning laws and enforcement.

Unidirectional airflow pattern in which the point-to-point readings of velocities are within the defined percentage of the average airflow velocity.ISO 14644-3.

Porosity that is distributed in a weldment in a uniform pattern.

A logically separable part of a computer program. Synonymous: Component.

(IEEE) A separately testable element specified in the design of a computer software element.

Defines an SVP that must be administered in one dose. Unused contents must be discarded.

A distinct chemical or physical step in a downstream process, such as ultrafiltration, centrifugation, or chromatography.

The purpose of each unit operation is either to make, isolate, purify, size, or package the intermediate or API.

IEC 61512 (S88): A unit procedure consists of an ordered set of operations that cause a contiguous production sequence to take place within a unit. Only one operation is presumed to be active in a unit at any time.

(IEEE) Testing conducted to verify the implementation of the design for one software element; e.g., a unit or module; or a collection of software elements. Synonymous: Component Testing.