Glossary

This specification covers the passivation of stainless steel alloys in the 200, 300, and 400 series, and the precipitation-hardened alloys, using electropolishing procedures.

This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety. This guide is applicable throughout the life–cycle of both new and existing manufacturing systems.

Occurring without a regular time relationship, i.e., timing independent.

A timing independent method of electrical transfer of data in which the sending and receiving units are synchronized on each character, or small block of characters, usually by the use of start and stop signals.

HVAC room condition when unmanned, and without machinery operating.

Condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present.

In water monitoring systems. (also see: Off-Line)

European Community (EC) defines “at rest” state as “the condition where the installation is complete with production equipment installed and operating but with no operating personnel present”. The Medicines Inspectorate, however, further clarifies, “It should normally be taken to mean that ventilation systems are operating and other equipment is present in an operational condition but not in use”.

A rare fatal disease involving a damaged immune system, unsteady walk, premature aging, and a strong predisposition to some kinds of cancer. People who possess only one copy of the gene, called ATM, do not have the disease, but may be predisposed to cancer and unusually sensitive to radiation.

Anatomical Therapeutic Chemical (Drug Classification System) (WHO)

American Type Culture Collection

Bureau of Alcohol, Tobacco and Firearms (United States Department of Justice)

Aluminum Trihydrate

A specific type of arteriosclerosis, but the terms are often used interchangeably. Atherosclerosis refers to the buildup of fats in and on artery walls (plaques), which can restrict blood flow. These plaques can also burst, causing a blood clot. Although atherosclerosis is often considered a heart problem, it can affect arteries anywhere in the body. Atherosclerosis is a preventable and treatable condition.

A type of laboratory mouse that is hairless, lacks a normal thymus gland, and has a defective immune system because of a genetic mutation. Athymic, nude mice are often used in cancer research because they do not reject tumor cells, from mice or other species.

This term refers to what the dewpoint would be if fully depressurized to atmospheric conditions (1013 mbar at either 15 or 20 °C (59 or 68 °F).(also see: Pressure Dewpoint)

(NFPA 30) A storage tank that has been designed to operate at pressures from atmospheric through 0.5 psig (3.4 kPa) measured at the top of the tank.

A highly sensitive instrumental technique for identifying and measuring metals in water.

Adenosine Triphosphate

A nucleotide of fundamental importance as a carrier of chemical energy in all living organisms. It consists of adenosine with three phosphate groups, linked together linearly. The phosphates are attached to adenosine through its ribose (sugar) portion. Upon hydrolysis, bonds yield either one molecule of ADP (adenosine diphosphate) and an inorganic phosphate, or one molecule of AMP (adenosine monophosphate) and pyrophosphate; in both cases releasing energy that is used to power biological processes. ATP is regenerated by rephosphorilation of AMP and ADP, using chemical energy derived from the oxidation of food.

American Technology Pre-Eminence Act of 1991

Association of Teachers and Preventive Medicine

Association of Teachers and Preventive Medicine

Applied Technologies Staff (CDER)

Agency for Toxic Substances and Disease Registry (CDC)