Revised Draft of Pharmeuropa Monograph 5.1.2. Biological Indicators

Recommendation

18/19 June 2024
Copenhagen, Denmark

Environmental Monitoring
Compliant and Reasonable

On 15 December 2011 the draft of the revised monograph 5.1.2. "biological indicators in the preparation of sterile products" - old title ' biological ' indicators of sterilisation " - was published in the Pharmeuropa 24.1 for comments. The number of comments and objections was so extensive that it was necessary to revise the draft completely. On 23 June 2015 the new version was published again in Pharmaeuropa 27.3 for public comment. 

The content of the new draft has been adjusted compared to the first draft. The new document's structure is as follows:
1.         Introduction
2.         Biological Indicators for sterilization processes
2.1.      Description of Biological Indicators for terminal sterilization processes
2.1.1.   Inoculated carriers
2.1.2.   Self contained Biological Indicators
2.1.3.   Characterised spore suspensions
2.1.4.   Custom-made Biological Indicators
2.2.      Quality requirements for Biological Indicators
2.2.1.   User requirement specifications (URS) for Biological Indicators
2.2.2.   Quality control
2.2.3.   Suitability for purpose
3.          Biological Indicators for heat sterilisation
3.1.       Parameter of Biological Indicators for heat sterilisation
3.1.1.    z-value
3.1.2     Establishment of validation cycle
3.2.       Biological Indicators for moist heat sterilisation
3.2.1.    Test micro-organisms
3.3.       Biological Indicators for dry heat sterilisation
3.3.1.    Test micro-organisms
4.          Biological Indicators for gas sterilisation
4.1.       Test micro-organisms
4.1.1     Ethylene oxide sterilisation
4.1.2.    Other processes
5.           Biological Indicators for ionising radiation sterilisation
5.1.        Test micro-organisms
6.           Biological Indicators for moist heat sterilisation
6.1.        Test micro-organisms
7.           Indicators for depyrogenation processes
7.1.       Characteristics of the indicator
7.2.       Test procedure
 
Following the main changes / new features compared with the draft from 2011 are summarised:
 
1. Introduction
 
Here it is noted that this document does not apply for the use of biological indicators to validate the sterility of pipework and other non-terminal units.
 
2. Biological Indicators for sterilisation processes
 
In addition to the previously described 3 types of bioindicator preparations - inoculated carriers, bioindicators in ampoules or tubes (self contained BIs), "custom-made biological indicators" - a 4th type "characterised spore suspension" is described. It consists of a defined number of spores prepared from a clearly characterised and suitable maintained strain of a spore forming bacterial species in stable suspension. Further new descriptions include the topics quality requirements for biological indicators, user requirements, quality control and suitability for purpose.
 
5. Biological Indicators for ionising radiation sterilisation
 
This topic has been removed in the first draft of the monograph. To demonstrate the suitability of the sterilisation cycle generally no BIs are needed. However, their use may be required for the development and validation of ionising radiation sterilisation in specific cases.
 
7. Indicators for depyrogenation processes
 
This chapter now contains a list of characteristics of the lipopolysaccharide preparations.

To get access to the document please use the following link. After the necessary registration, you have access to the new draft "5.1.2. biological indicators and related microbial preparations used in the manufacture of sterile products, and indicators for depyrogenation processes".

The commenting period ends on 30 September 2015.