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 moist heat (heating in an autoclave)

  • Water-wettable materials only, and aqueous formulations

  • Temperature, time and pressure monitored

  • Temperature recorder independent of the controller

  • Independent temperature indicator

  • Drain - temperature recorded from this position

  • Regular leak test when vacuum is part of the cycle

  • Material allows for removal of air and penetration of steam

  • All parts of the load in contact with steam

  • Quality of the steam - no contamination

Sterilization by moist heat (heating in an autoclave)

The method can be used for water-wettable materials only, and aqueous formulations. During sterilization, the temperature, time and pressure should be monitored. The temperature recorder should be independent of the controller. An additional independent temperature indicator can be used.

If the autoclave is fitted with a drain, then the temperature should be recorded from this position.

A regular leak test should be done when vacuum is part of the cycle

Material used to pack materials / product should allow for the removal of air and penetration of steam

All parts of the load has to come in contact with steam to ensure sterilization. You have to check that the manufacturer has procedures, specifications, and test methods to ensure that the quality of the steam used is acceptable and that it cannot be an accidental source of contamination

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Dernière mise à jour: le 3 mai 2013