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

Terminal Sterilization

  • Sterilization by heat

  • Sterilization by moist heat

  • Sterilization by dry heat

  • Sterilization by radiation

  • Sterilization by gases and fumigants

It is not possible to deal with all the aspects and requirements for sterilisation in the basic module. The information provided here is only a brief introduction. It is recommended that the novice inspector should have an experienced inspector with him/her or an expert, when performing an inspection of sterile product manufacture. An expert adviser should be considered for an in-depth assessment. Let us now look at the different methods of sterilisation. We will first look at the basic principles of heat sterilisation, and then review the different methods.

Methods of Terminal Sterilization

Sterilization by heat

Sterilization by moist heat

Sterilization by dry heat

Sterilization by radiation

Sterilization by gases and fumigants

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Última actualización: le 3 mayo 2013