CHANGES TO THE Ph.Eur CHAPTERS FOR METHODS OF PREPARATION OF STERILE PRODUCTS 5.1.1 AND BIOLOGICAL INDICATORS 5.1.2
Chapters 5.1.1and 5.1.2 concerning sterilisation and biological indicators have been significantly revised with the implementation of Revision 9.2 Ph.Eur in July2017.
These chapters have been revised to reflect modern sterilisation processes and have introduced new requirements for users of biological indicators which effect both the selection process and the way we use them during qualification activities.
Marcus Booth, Head of Training & Consultancy at Honeyman Group Ltd has written a white paper based on these changes.
In light of these changes, Honeymans Sterilisation: Principles in Practice Training Course has been revised to include these updates and in the course we offer pragmatic solutions for our delegates to meet the new requirements.
Use of reduced cycle parametersduring validation testing
Specifying and re orderingbiological indicators
General Biological indicatorpopulations and D values
Requirement for URS forbiological indicators
Correlation between (Fphys) and (Fbio)
The next Sterilisation: Principles in Practice course begins on 12th September 2017