ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Decontamination

(USP <1072>) The removal of microorganisms by disinfection or sterilization.

Publication Source: -

Decontamination

Process that reduces, detoxifies and/or eliminates contaminated substances to a predetermined acceptance level.

Publication Source: ISPE Baseline® Guide, Vol. 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Publication Date: 2010

Decontamination

(FDA 2004 Aseptic Pocessing Guidance) A process that eliminates viable bioburden via use of Sporicidal chemical agents.

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)

Publication Date: 2011

Decontamination

A process that reduces contaminating substances to a defined acceptance level.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

See also: Bioburden Decontamination Overkill Decontamination

Decontamination

Reduction of unwanted matter to a defined degree.

Publication Source: ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled environments” – Part 6: Terms and Definitions

Decontamination

A process that reduces contaminating substances to a defined acceptance level.

Publication Source: GAMP® good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
Publication Date: 2012

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