Articles by Klaus Haberer - Pharmaceutical Technology

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Articles by Klaus Haberer

Klaus Haberer


Klaus Haberer, PhD, is the managing director at Compliance Advice and Services in Microbiology GmbH.

A Risk-Based Approach to the Use of Biological Indicators in the Development and Control of Steam-Sterilization Processes
May 1, 2007

Validating the sterilization process is extremely important in pharmaceutical manufacturing. The authors explore different types of sterilization processes and discuss the importance of finding the worst-case positions of loads or equipment to be sterilized and the worst-case conditions for each sterilization cycle. Biological indicators (BIs) can be used to simulate worst-case scenarios and determine the effectiveness of a particular sterilization process.

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