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?
D-value is the term used to describe the amount of time required to kill or destroy a microorganism. Spores are much more difficult to kill than vegetative cells, which is why we use spores as our Biological Indicator for the effectiveness monitor of our sterilization process. D121 tells us how many minutes it takes to kill an organism at 121°C (or 250°F). The D-value is the time required to reduce a population of microorganisms by one log at the process temperature. From 1x106 to 1x105 – from 1,000,000 to 100,000 organisms. Z-value of a microorganism is a measure of how heat resistance changes with changes in temperature. Z is defined as the number of degrees temperature change to change the D-value by a factor of 10.
The Z-value allows integration of the lethal effect of heat as the temperature changes during the heating and cooling phases of a sterilization cycle. D121 tells us how many minutes it takes to kill an organism at 121°C (or 250°F). This webinar will also cover the different elements that affect D-value and z-value and how to calculate the probability that a defined cycle is going to give us the SAL and PNSU that is needed to ensure that only or less than 1 in a million patients might have a problem due to sterility issues as well as reviewing what has caused a number of FDA Warning Letter due to inappropriate sterilization development, validation and on-going assessment of the process.
Why Should you Attend:
Attend this webinar to understand the definition of sterile, what are the different sterilization methods, various approaches to be used for the validation of a sterilization process, and what are the requirements for routine monitoring and control of sterilization process.
Objectives of the Presentation:
The prime objectives of the presentation are to discuss the mathematical means of developing and proving that the sterilization process is effective and does not generate a problem for heat liable products. The speaker will also cover areas such as:
Who can Benefit:
- Linear Regression used to calculate the edge of failure
- Survivor Curves to determine D-values and Z-values
- 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
- Manufacturing Operations
- Product and Process Development
- Regulatory Affairs
- Research and Development
- Sterility Assurance
- Technical Operations and Validation Professionals
- Inspectors and Auditors.