ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Removal, destruction, or de-activation of microorganisms on objects or surfaces. ISO 14644-5.

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

Publication Date: 2004

See also: Sanitization


Process by which viable microbiological agents or eukaryotic cells are reduced to a level unlikely to produce disease in healthy people, plants, or animals. These processes may use chemical agents, heat, ultraviolet light, etc. to destroy most (but not necessarily all) of the harmful or objectionable microorganisms, pathogens, and potential pathogens. Disinfection does not necessarily result in sterilization.

1. “High level disinfection” inactivates fungi, viruses, and bacteria. High-level chemical disinfectants maybe ineffective against bacterial spores if they are present in large numbers. Extended exposure times may be required.

2. “Intermediate level disinfection” destroys fungi, some viruses (lipid and most non-lipid medium-size and small viruses), mycobacteria, and bacteria.

3. “Low level disinfection” kills vegetative forms of bacteria, some fungi, and some medium-size and lipid-containing viruses. Low-level disinfectants do not reliably kill bacterial spores, mycobacteria, or small or non-lipid viruses.

See also: Decontamination Sanitization

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