Glossary

Blood and Tissue Compliance Branch (CBER)

Blood and Tissue Registration System

The unit used to measure the amount of heat in a substance. One Btu is the heat required to produce a temperature rise of 1°F. in one lb. of water.

Blue Tongue Virus

(IEEE) A data flow, data structure, or other diagram in which entities are depicted with circles (bubbles) and relationships are represented by links drawn between the circles.

The minimum pressure required to overcome surface tension and capillary forces holding a liquid in the pores of a membrane filter.

A filter leakage test in which the filter is wetted and air pressure is applied and slowly increased until water is expelled from the largest pores and bubbles appear from a submerged tube in a downstream collection vessel. Vigorous bubbling, as opposed to a diffusional airflow or occasional bubbles, is indicative of reaching the bubble point. This visual test can be fairly accurate for low area filters, such as discs. When used to evaluate high area filters, it is subject to limitations in observation, test time, collection conditions, and pressurization rates. The bubble point test is not recommended for integrity testing of filter cartridges.

Buffalo (New York) District Office (ORA)

A solution containing a weak acid and a conjugate base of this acid; it resists change in its pH level when an acid or a base is added to it, because the acid neutralizes an added base and vice versa.

A substance capable of neutralizing both acids and bases in solution, thereby maintaining the original acidity or causticity of the solution.

A device or storage area (memory) used to store data temporarily to compensate for differences in rates of data flow, time of occurrence of events, or amounts of data that can be handled by the devices or processes involved in the transfer or use of the data.

Section of most biotech facilities devoted to the preparation of controlled bioburden buffer solutions for use in the chromatographic separation area of those facilities.

A fault in a program which causes the program to perform in an unintended or unanticipated manner.

Biosecure Underground Growth Chambers

A system which collects baseline building information that addresses predetermined facility components.

Group of components defined, installed, and controlled by a set of specifications defined by the company to maximize opportunity for reuse.

A computerized system that controls, monitors, and optimizes environmental conditions, through functions and facilities such as heating, air-conditioning, lighting, and security.

A computerized system that controls, monitors, and optimizes building services, this may include environmental conditions, heating and cooling systems, elevator systems, lighting, and security.

Usually a commercial grade, distributed control system to manage a building HVAC, security, and/or fire protection systems. Methods for commissioning and qualifying HVAC under a BMS are discussed in the ISPE Baseline® Guide for Commissioning and Qualification.

2007 California Building Code‚ Title 24‚ Part 2. Structures or portions of structures shall be classified with respect to occupancy in one or more of the groups listed below. A room or space that is intended to be occupied at different times for different purposes shall comply with all of the requirements that are applicable to each of the purposes for which the room or space will be occupied. Structures with multiple occupancies or uses shall comply with Section 508. Where a structure is proposed for a purpose that is not specifically provided for in this code, such structure shall be classified in the group that the occupancy most nearly resembles, according to the fire safety and relative hazard involved.The occupancy groups are as follows:1.Group A – Assembly (Section 303): Groups A-1, A-2, A-3, A-4 and A-52.Group B – Business (Section 304)3.Group E – Educational (Section 305)4.Group F – Factory and Industrial (Section 306): Groups F-1 and F-25.Group H – High Hazard (Section 307): Groups H-1, H-2, H-3, H-4 and H-56.Group I – Institutional (Section 308): Groups I-1, I-2, I-3 and I-47. Laboratory (Section 202): Group B, unless classified as Group L (Section 443) or Group H (Section 307)8.Group M – Mercantile (Section 309)9.Group C – Organized Camps (Section 440)10.Group L – Research Laboratories (Section 443)11.Group R – Residential (Section 310): Groups R-1, R-2, R-3, R-3.1 and R-412.Group S – Storage (Section 311): Groups S-1 and S-213.Group U – Utility and Miscellaneous (Section 312)Existing buildings housing existing protective social care homes or facilities established prior to 1972 (see Section341.3).

Any product that has completed all processing stagesup to, but not including, final packaging.

The transferring of flammable or combustible liquids from tanks or drums into smaller containers for distribution.

The material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers. (also see: Drug Substance)