Abstract
The manufacturing of parenteral formulations should include a sterilization step in order to maintain product quality. How the most common sterilization techniques are performed and some of the advantages and disadvantages of each type will be summarized. Sterilization methods that will be covered include the fundamentals of steam, radiation, and ethylene oxide terminal sterilizations, as well as aseptic processing. Once a sterilization cycle or procedure has been chosen and developed, its effectiveness should be validated according to the guidelines of the respective authorities. Some of the documentation that regulators may review to decide whether they believe a method is acceptable is summarized in this chapter. While regional regulatory authorities may differ on what types of information should be submitted to their agencies and what should be reviewed during field inspections of a manufacturing facility, the focus for this chapter will be validation information and Good Manufacturing Practices aspects of sterilization techniques.
The opinions and information in this chapter are those of the author and do not necessarily reflect the views and policies of the U.S. Food and Drug Administration.
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Notes
- 1.
ISO 11137–2 bases its rationale for allowing two positives upon the assumption that the probabilities of occurrence of numbers of positives around an average of one positive are distributed according to the Poisson distribution. With this distribution, there is a probability of 92 % that zero, one or two positives will occur.
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Hunter, G.W. (2013). Basics of Sterilization Methods. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_18
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