PT  - JOURNAL ARTICLE
AU  - Paul Faya
AU  - James D. Stamey
AU  - John W. Seaman, Jr.
TI  - A Bayesian Approach to Determination of <em>F, D</em>, and <em>Z</em> Values Used in Steam Sterilization Validation
AID  - 10.5731/pdajpst.2016.006981
DP  - 2017 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 88--98
VI  - 71
IP  - 2
4099  - http://journal.pda.org/content/71/2/88.short
4100  - http://journal.pda.org/content/71/2/88.full
SO  - PDA J Pharm Sci Technol2017 Mar 01; 71
AB  - 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 DT, z, and Fo 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.LAY 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 critical process parameters that are evaluated in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these parameters 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.