Glossary

Weight per volume; the weight of a constituent in 100 cm3 of solution, expressed as a percentage.

Under limited circumstances, a waiver of the requirement for authorization for use or disclosure of private health information may be obtained from the IRB by the researcher. A waiver of authorization can be approved only if specific criteria have been met.

A method for cloning large regions of a chromosome. Starting from a known site, a gene library is screened for clones that hybridize to DNA probes taken from the ends of the first clone. These clones are then isolated, and their ends used to screen the library again. These clones are then isolated and their ends used, and so on.

Pressure that a cell wall exerts against the turgor of the cell contents. Wall pressure is equal and opposite to the turgor potential.

Wide Area Network

Wireless Access Point

Any temperature between 30º and 40ºC (86º and 104ºF) is warm.

(BPI) The most serious FDA postaudit (after inspection) letter, notifying a manufacturer of adverse inspection findings and giving it 15 days to reply with a concrete plan for remediation. May or may not be associated with other actions, such as injunction, consent decree, or product seizure.

Product guaranties for a product to perform to a defined standard for a specified period of time.

Flushing a column with a large volume of a solvent or buffering agent prior to selective elution of the desired analyte.

Heat discharged as a byproduct of one process to provide heat needed by a second process. (e.g., the process of recovering heat from hot streams with potential high energy content such as hot flue gases from a diesel generator or steam from cooling towers or even waste water from different cooling processes such as in steel cooling.

The collection, transportation, and disposal of garbage, sewage, and other waste products. Waste management encompasses management of all processes and resources for proper handling of waste materials, from maintenance of waste transport trucks and dumping facilities to compliance with health codes and environmental regulations.

Water that has been used and contains dissolved or suspended waste materials.

(IEEE) A form of interval timer that is used to detect a possible malfunction.

WFI in bulk is obtainedfrom water that complies with the regulation on water intended for human consumption laid down by the competent authority, or from purified water, by distillation in an apparatus of which the parts inc ontact with the water are of neutral glass, quartz or suitable metal and which is fitted with an effective device to prevent the entrainment of droplets. The correct maintenance of the apparatus is essential. During production and storage, appropriate measures are taken to ensure that the total viable aerobic count is adequately controlled and monitored. WFI complies with the tests for Purified water with additional requirements for bacterial endotoxins (not more than (nmt) 0.25 IU endotoxins per ml), conductivity and Total Organic Carbon.

Prepared from water complying with the quality attributes of “Drinking Water.” Purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. Conductivity in accordance with Stage 1, 2, and 3 tests and Conductivity Tables. Total Organic Carbon limit is at 0.5 mg/l. Typically less than 10 CFU/100ml for microbiological acceptability. Less than 0.25 USP EU/ml.

Water purified by distillation or by reverse osmosis, it contains no added substance, and it meets the purity requirements under Purified Water. Although not intended to be sterile, it meets a test for a limit of bacterial endotoxin (less than 0.25 USP En

Prepared from water complying with the quality attributes of “Drinking Water.” Purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. Conductivity in accordance

Water for the preparation of medicines for parenteral administration when water is used as vehicle (water for injections in bulk) and for dissolving or diluting substances or preparations for parenteral administration (sterilized water for injections).Water for injections in bulk is obtained from water that complies with the regulation on water intended for human consumption laid down by the competent authority, or from purified water, by distillation in an apparatus of which the parts in contact with the water are of neutral glass, quartz or suitable metal and which is fitted with an effective device to prevent the entrainment of droplets. The correct maintenance of the apparatus is essential. The first portion of the distillate obtained when the apparatus begins to function is discarded and the distillate is collected. During production and storage, appropriate measures are taken to ensure that the total viable aerobic count is adequately controlled and monitored. Under normal conditions, an appropriate action limit is a total viable aerobic count of 10 micro-organisms per 100 ml when determined by membrane filtration, using agar medium S. using at least 200 ml of water for injections in bulk and incubating at 30-35 °C for five days. For aseptic processing, stricter alert limits may need to be applied. Total organic carbon: maximum 0.5 mg/L

A tremendous force produced by rapid interruption of linear flow of a non-compressible fluid. Most commonly occurs when fast acting valves are closed in a high flow liquid system.

Refers to the difference between the activity of water molecules in pure distilled water at atmospheric pressure and 30°C (standard conditions), and the activity of water molecules in any other system. The activity of these water molecules may be greater (positive) or less (negative) than the activity of the water molecules under standard conditions.

Water treatment, also referred to as water conditioning, can consist of adding or removing chemicals to change the properties of water. In water softening, for example, sodium ions are substituted for metallic ions that cause “hardness” thus reducing the scale-forming tendencies of water. Water purification on the other hand, always consists of removing undesirable impurities.

Water treatment, also referred to as water conditioning, can consist of adding or removing chemicals to change the properties of water. In water softening, for example, sodium ions are substituted for metallic ions that cause “hardness” thus reducing the scale-forming tendencies of water. Water purification on the other hand, always consists of removing undesirable impurities.