Tuesday, 16 December 2014

European Pharmacopeia - Preparation of Sterile Products

Chapter 5.1.1 of the European Pharmacopeia is undergoing review and a draft has been published in Pharm Europa, titled “Methods of Preparation of Sterile Products.”

In relation to the changes:
  • In the introduction, the reference to GMP has been removed;
  • In the section Sterility assurance level, the reference to exponential inactivation has been removed as membrane filtration is not a first order process;
  • The sections on the different sterilisation processes, where appropriate, now have the same format: principle, equipment, sterilisation cycle, cycle effectiveness and routine control; where required, relevant information has been added;
  • Modern concepts for validation of steam sterilisation have been added;
  • A wider description of the equipment suitable for dry heat sterilisation has been provided;
  • In the section Ionising radiation sterilisation, the reference to European Notes for Guidance
  • has been removed;
  • In the section Gas sterilisation, two different types of agents are defined: alkylating agents and oxidising agents. The establishment of the cycle effectiveness has been described in more detail;
  • In the section Membrane filtration, the description of the microbial challenge test has been removed as it is proposed for inclusion in the revised chapter on biological indicators;
  • In the section Aseptic preparation, freeze-drying under aseptic conditions is added.

The draft can be found in Pharmeuropa edition 26.4

Posted by Tim Sandle