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WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(2006; 62 pages)
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Sterile Production

Sterilization

  • Methods of sterilization

    - moist or dry heat

    - irradiation (ionizing radiation)

    - sterilizing gaseous agents (e.g. ethylene oxide)

    - filtration with subsequent aseptic filling

  • Whenever possible: terminal sterilization by heat in their final container - method of choice

We are now going to talk about sterilization in more detail, with particular reference to the different methods of sterilization. There are a number of available methods, each of which has advantages and disadvantages. Heat sterilization should always be the preferred method if it can be used.

Methods of sterilization include:

Moist or dry heat

Irradiation (ionizing radiation)

Sterilising gaseous agents (e.g. ethylene oxide)

Filtration with subsequent aseptic filling

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Last updated: May 3, 2013