A Risk-Based Approach to the Use of Biological Indicators in the Development and Control of Steam-Sterilization Processes - Pharmaceutical Technology

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A Risk-Based Approach to the Use of Biological Indicators in the Development and Control of Steam-Sterilization Processes
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.


Pharmaceutical Technology


12. ISO 11138-1, "Sterilization of Health Care Products—Biological Indicator Systems," 2005.

13. European Pharmacopoeia, Chapter 5.1.2 "Biological Indicators of Sterilization," 5.7th ed. (Council of Europe, Strasbourg, 2007).

14. European Pharmacopoeia, 5.7th ed. (Council of Europe, Strasbourg, 2007).

15. The United States Pharmacopeial Convention, Monograph Section, United States Pharmacopeia 30, CD edition (2007).


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