EU GMP proposed changes to Moist Heat Sterilisation Requirements

At Honeyman, our aim is keep our clients up to date with all the current regulatory requirements as well as providing an impartial view on future changes that might affect you.

Critical Factors for Sterile Product Manufacture

As we communicated earlier via our e-news bulletin, there are a significant amount of proposed changes to Annex 1 of the EU GMP.

In this edition we highlight the EU GMP proposed changes to Moist Heat Sterilisation Requirements;

There have been a number of changes to the text surrounding steam sterilisation of product contact parts (porous loads), Steam In Place and terminal sterilisation of finished product in sealed containers

The changes are summarised below:

  1. Change to feed water requirements for steam generation system
  2. New requirements for assessing the quality of steam used for porous load sterilisation or SIP applications.
  3. For aseptic operations an assessment of maximum hold times for sterile equipment, components or containers is required
  4. Where a product cannot be terminally sterilised consideration should be given to terminal bioburden reduction steps combined with aseptic processing
  5. New requirements regarding verification of process effectiveness
  6. Additional requirements around product segregation
  7. Additional requirements for protection of product/ materials after sterilisation
  8. New requirements for heat penetration and distribution studies
  9. New requirements for inspection of sterilised items
  10. New requirements for validation and parameters to record and consider
  11. New requirements for assessment of load dryness
  12. SIP validated hold time requirements
  13. New requirements for bioburden monitoring of terminal sterilisation processes
  14. New requirements for samples taken for sterility testing

Pharmaceutical Sterilisation

During our up and coming courses:

Critical Factors for Sterile Product Manufacturing  

and

Pharmaceutical Sterilisation: Principles in Practice®

Our experts will discuss the changes in more detail, provide impartial views on the changes and offer a round the table discussion with all delegates to generate a greater understanding.

If you wish to find out more about our Critical Factors for Sterile Product Manufacturing and Pharmaceutical Sterilisation: Principles in Practice® course, please click on the respective links, email us on enquiries@honeymangroup.com or contact us on +44(0)1833 690101 and ask to speak to one of our training consultants.

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