Mathematics Of Terminal Sterilization – Probability Of Survival Approach -Vs- Overkill Approach
- From the topics listed above the areas covered provide the mathematical means of developing and proving the sterilization process is effective and does not generate a problem for heat liable products
- Survivor Curves to determine D-values and Z-values
- Linear Regression used to calculate the edge of failure
- Fraction Negative studies
- Cold spot determination – product and chamber – TD and HP
- Correction factors associated with heating and cooling
- Calculation of process lethality
- Laboratory Studies needed to support Sterilizer Studies
- Biological Indicators to be used and how to make the selection
- Identification of elements in the process that can affect D-value
Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme thermophile organisms have their optimal growth temperature at 110°C, whereas most vegetative cells are killed at 60°C.
Heat sterilization is a probability function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenterals and medical devices. Since regulations require that we generate in our sterilization processes a probability of a non-sterile unit (PNSU), how do we use D-values, Z-values and Fo to calculate the probability and determine that we have essentially zero risk in our products due to lack of sterility?
FDA wants me to teach this to their field inspectors. Since there is so much different interpretation of regulatory statements and because different agencies have different philosophies, those who do not have a deep comprehension of the sterilization design relative to the microbiological impact (why many sterilizers have been improperly designed), we will discuss the definition of “Sterile” and how to get there by describing different sterilization methods, various approaches to be used for the validation of a sterilization process using moist heat as template that can be used for other sterilization methods and what requirements for routine monitoring and control of sterilization are required
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectable, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.
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