Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach 2016

Topics

• Linear Regression used to calculate the edge of failure
• Survivor Curves to determine D-values and Z-values
• Correction factors associated with heating and cooling
• Fraction Negative studies
• Calculation of process lethality
• Cold spot determination - product and chamber - TD and HP
• 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

Who should Attend

Attendees involved or interested in:

• Formulation
• Manufacturing Operations
• QA/QC
• Engineering
• Regulatory Affairs
• Product and Process Development
• Sterility Assurance
• Research and Development
• Inspection
• Technical Operations and Validation
• Auditing