Introduction

Over recent years the pharmaceutical industry has seen significant changes to the way that it operates due to the increasing introduction of new technology, more focus on the application of science and more reliance on statistical methods to demonstrate confidence in process control. To enable this transition, many of the regulations and guidelines within the industry have been significantly revised to reflect the change in emphasis. In the field of sterilisation, this has resulted in the USP completely rewriting the text on sterilisation processes and biological indicators with the creation of USP chapter <1229> Sterilisation of Compendial Articles. This phased implementation started in 2013 and is still ongoing with new chapters being introduced in USP40. In Europe the General Chapters concerning Sterilisation 5.1.1 Methods of Preparation of Sterile Products and 5.1.2 Biological Indicators for Sterilisation started the revision process in 2009 and had se...

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