Abstract
For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the well-known D_T, z, and F_o values that are used in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these values to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion.
- Received June 17, 2016.
- Accepted October 12, 2016.
- Copyright © 2016, Parenteral Drug Association
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