Biological Indicators And The European Pharmacopoeia

By Nicole Robichaud

Mesa Labs manufactures biological indicators (BIs) in compliance with the United States Pharmacopeia (USP) and the ISO 11138 series, Sterilization of Health Care Products – Biological Indicators. On August 1, 2016, a new revision of the USP was made available which included significant changes to the general chapters and monographs pertaining to BIs, as detailed in Spore News Volume 13, No. 1. In February 2017, a revision to the ISO 11138 series was published and the changes were outlined in Spore News Volume 13, No. 2.

A new revision of the European Pharmacopoeia (EP) General Chapter 5.1.2, concerning BIs, was published July 1, 2017. Although Mesa Labs’ did not previously claim compliance to the EP, many of our international customers do and for this reason, this Spore News article will focus on the new revision EP 9.2, 5.1.2.

The previous version of EP 5.1.2 was concise compared to the new revision and consisted of only five sections. The first section provided a general description of BIs, BI characterization by organism and D-value, placement of BIs in a sterilisation load and choice of indicator organisms for BIs. The next four sections each pertained to specific sterilisation processes, Steam sterilisation, Dry-heat sterilisation, Ionising radiation sterilisation and Gas sterilisation. Each of these sections provided pertinent information such as the organism recommended for the sterilisation process and the recommended minimum BI population and D-value for each process.

The new revision of EP 5.1.2 consists of six sections and each section contains many subsections; the information is more detailed and covers a wider scope than the previous version. A summary of each section is provided below.