Glossary

Device capable of removing particles smaller than those of interest that is attached to the inlet of a discrete-particle counter or condensation nucleus counter.

Cumulative distribution of particle concentration as a function of particle size.

A physically measurable contaminant in deionized water. Particles can be bacteria, colloidal material or any other insoluble material. Particle counts are reported as number of particles per liter of a particular size measured in micrometers (microns).

Particles generated within a space by a process and occupants per unit time.

Usually a solid particle large enough to be removed by filtration. Nonfilterable solids are usually referred to as colloids.

Usually a solid particle large enough to be removed by filtration.

For the purpose of this Guide (ISPE GPG Assessing the Particulate Containment Performance of Pharmaceutical Equipment) the term “particulate material” will be used to refer to the airborne surrogate material generated during a representative process. This term will be used in place of dust, as the term “dust” represents all airborne particulate matter that may be present during a containment assessment verification study.

Discrete quantities of solid matter dispersed in water.

Polyarylsulfone

Prior Approval Supplement

A high-level programming language designed to encourage structured programming practices.

The transfer or transplantation of cells from one culture vessel to another.

(ASTM A 380) The process by which a stainless steel will spontaneously form a chemically inactive surface when exposed to air or other oxygen-containing environments, providing that the surface has been thoroughly cleaned or descaled. (also see: Descaling)

(ASTM A 380) The chemical treatment of a stainless steel with a mild oxidant, such as a nitric acid solution, for the purpose of enhancing the spontaneous formation of the protective passive film. Such chemical treatment is generally not necessary for the formation of the passive film.

The means of obtaining the loss of chemical reactivity exhibited by certain metals under special environmental conditions. More specifically, the state in which a stainless steel exhibits a very low corrosion rate. Passivation generates an oxide film that covers and protects the surface of the metal.

(ASTM A 380) Preferred definition for the biopharmaceutical industry. - Removal of exogenous iron or iron compounds from the surface of a stainless steel by means of a chemical dissolution, most typically by a treatment with an acid solution that will remove the surface contamination but will not significantly affect the stainless steel itself. Unless otherwise specified, it is this definition of passivation that is taken as the meaning of a specified requirement for passivation.

Removal of exogenous iron or iron compounds from the surface of stainless steels and higher alloys by means of a chemical dissolution, most typically by a treatment with an acid solution that will remove the surface contamination and enhance the formation of the passive layer.

The means of obtaining the loss of chemical reactivity exhibited by certain metals under special environmental conditions. More specifically, the state in which a stainless steel exhibits a very low corrosion rate. Passivation generates an oxide film that covers and protects the surface of the metal.

A final chemical treatment/cleaning process that removes exogenous iron or iron compounds from the surface of stainless steel piping and equipment by the use of a mild oxidant, such as a nitric acid solution, or by “in-situ electropolishing. The purpose of passivation is to restore and/or enhance the spontaneous formation of the chemically inert surface or protective passive film.

Temporary immunity produced by administration of gamma globulin.

A passive oxidized film that forms naturally on a stainless steel surface when exposed to air or similar oxidizing environment thus protecting the underlying base metal from corrosion.

A chromium enriched oxide layer on a stainless steel surface, that improves the corrosion resistance of the base metal.NOTE: The use of the word “film” as in ‘passive film’ is discouraged.

Refers to the use of the sun's energy for the heating and cooling of living spaces. In this approach, the building itself or some element of it takes advantage of natural energy characteristics in materials and air created by exposure to the sun.(also see: Active Solar)