Clean Room / Contamination Control
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Axel Henning Schroeder Premium Member Group moderatorThe company name is only visible to registered members.Monographie Entwurf zu Bioindikatoren
On 15 December 2011, the draft of the revised monograph 5.1.2. "Biological Indicators (BIs)in the Preparation of Sterile Products" (formerly "Biological Indicators of Sterilisation") was published for comment in the Pharmeuropa. The deadline for comment is 31 March 2012.
The content of the draft has been completely revised to meet the current technological developments. Here an overview of the main chapters:
1. Introduction
2. BIs for sterilisation processes
2.1. Description of BIs
2.1.1. Inoculated carriers
2.1.2. Self-contained BIs
2.1.3. Custom-made BIs
2.2. Requirements for BIs
2.2.1. Manufacturer's responsibilities for BIs
2.2.2. User responsibilities for BIs
2.3. BIs for steam sterilisation
2.3.1. Test micro-organisms
2.3.2. z-value
2.3.3. Choice of BI units or spore inoculation
2.4. BIs for dry heat sterilisation
2.4.1. Test micro-organisms
2.4.2. Resistance of BI-units
2.5. BIs for gas sterilisation
3. Microbiological evaluation of membrane filtration
4. Indicators for depyrogenation processes
4.1. Characteristics of the indicator
A summary of the most significant changes and improvementscan be found at
http://www.gmp-compliance.org/eca_news_2917_7136,7184,7255,7...
- 25 Jan 2012, 4:09 pm
