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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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Decontamination
(USP <1072>) The removal of microorganisms by disinfection or sterilization.
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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