ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Sterilization

The act or process, physical or chemical, that destroys or eliminates all forms of life (e.g., microorganisms). Despite being stated as an absolute, the action of sterilization is stated in terms of probability.

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

Publication Date: 2011

Sterilization

Refers to the killing of microorganisms in the distribution system. This is normally done periodically by flushing a sterilizing solution, such as hydrogen peroxide or ozone, through the distribution piping system. In some systems, ozone is continuously injected at low levels for continuous sterilization.

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

Publication Date: 2011

Sterilization

The act or process, physical or chemical, that destroys or eliminates all viable microbes including resistant bacterial spores from a fluid or a solid. Despite being stated as an absolute, the action of sterilization is usually stated in terms of probability of survival of a known quantity of a specific microorganism. Examples of sterilization methods are: steam treatment at 121ºC, dry heat at 450ºF, flushing with a sterilizing solution such as Hydrogen Peroxide (H2O2) or ozone (O3), irradiation, and filtration.

Sterilization

The act or process, physical or chemical that destroys or eliminates living microorganisms. Despite being stated as an absolute, the action of sterilization is usually stated in terms of probability of survival of a known quantity of a specific microorganism (Fo). Equipment is most often sterilized using clean steam.

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

Publication Date: 2004

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