ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Passivation

(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.

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (Second Edition)

Publication Date: 2011

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.

Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

Publication Date:

Passivation

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.

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (Second Edition)

Publication Date: 2011

Passivation

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.

See also: ASTM A 380 (Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems)

Passivation

(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.

Passivation

(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)

See also: Descaling (metals)

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