Glossary

Types of process water used in biopharmaceutical processing, ranging from municipal (“potable”) water to Water for Injection (WFI).

(IEEE) A model of the software development process in which the constituent activities, typically a concept phase, requirements phase, design phase, implementation phase, test phase, installation and checkout phase, and operation and maintenance, are performed in that order, possibly with overlap but with little or no iteration.

The distance between two corresponding points on any two consecutive waves. For visible light it is very small and is generally measured in nanometres.

The more widely spaced component of surface texture. Unless otherwise noted, waviness includes all irregularities whose spacing is greater than the roughness sampling length. Waviness may result from such factors as machine or work deflection, vibration, chatter, heat treatment, or warping strains. Roughness may be considered as superimposed on a "wavy" surface.

Undulations or rippling of the surfaces.

Work Breakdown Structure

Working Cell Bank

Well-Characterized Biopharmaceutical Product

Workplace Environmental Exposure Levels

Water Environment Federation

The shape, dimensions, and configuration of the weld joint.

A process used to join metals by the application of heat. Fusion welding, which includes gas, arc, and resistance welding, requires that the parent metals be melted. This distinguishes fusion welding from brazing. In pressure welding joining is accomplished by the use of heat and pressure without melting. The parts that are being welded are pressed together and heated simultaneously, so that recrystallization occurs across the interface.

One who operates machine or automatic welding equipment.

(CMC-BWG) A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality and which has a low risk of falling outside the design space.

Workplace Exposure Limits

A technique in which protein is transferred from an electrophoretic gel to a cellulose or nylon support membrane following electrophoresis. A particular protein molecule can then be identified by probing the blot with a radiolabelled antibody which binds only the specific protein to which the antibody was prepared. Useful, for example, for measurement of levels of production of a specific protein in a particular tissue or at particular developmental stage.

The surface(s) of any valve or component that will be exposed to a fluid (liquid or gas) when in service.

USP Water for Injection. USP Water for Injection. Prepared from water complying with the quality attributes of “Drinking Water.” Prepared using Distillation or Double pass reverse osmosis. Conductivity in accordance with Stage 1, 2, and 3 tests and conductivity tables. Total Organic Carbon at 0.5 mg/l. Less than 0.1 CFU/ml (10 CFU/100ml) for FDA acceptability. Less than 0.25 USP EU/ml.

USP Water for Injection. 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 For Injection

A classification of eater according to compendial standards.

(EMEA) Water for the preparation of medicines for parenteral administration when water is used as a vehicle (water for injection in bulk) and for dissolving or diluting substances or preparations for parenteral administration before use (sterilized water for injection). Control of the chemical purity of WFI presents few major problems. The critical issue is that of ensuring consistent microbiological quality with respect to removal of bacteria and bacterial endotoxins. Distillation has a long history of reliable performance and can be validated as a unit operation, hence it currently remains the only official method for WFI.WFI 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. 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.

World Green Building Council

Deals with the industrial application of biocatalysts in contained systems for the production or modification of chemicals. To emphasize the industrial aspect, this technology was originally known as grey biotechnology. Production processes in white biotechnology can be divided into fermentations and bioconversions.

A blood cell containing no respiratory pigment. In vertebrates it may be a polymorphonuclear leukocyte, a lymphocyte, or a monocyte.