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

This course will detail various sterilization methods and various approaches for the validation of a sterilization process.

Why Should You Attend:

Since there are so many different interpretations of regulatory statements and because different agencies have different philosophies, and there are those who need a deeper comprehension of the sterilization design relative to microbiological impact, this course will:

Discuss the definition of ‘sterile’

• Elaborate how to get there by describing different sterilization methods
• Discuss various approaches for the validation of a sterilization process using moist heat as template
• List requirements for routine monitoring and control of sterilization
• Review causes for FDA issuing Warning Letters for inappropriate sterilization development, validation and on-going assessment of the process
• This webinar will address such essential process questions and also discuss lethality, the different elements that affect D-value and Z-value, and how to calculate the probability that a defined cycle is going to give the Sterility Assurance Level (SAL) and Probability of a Non-Sterile Unit (PNSU) needed to ensure that none or maybe one in a million patients might have a problem due to sterility issues.

Areas Covered in the Webinar:

• Survivor curves to determine D-values and Z-values
• Linear regression used to calculate the edge of failure
• Fraction negative studies
• Correction factors associated with heating and cooling
• Cold spot determination - product and chamber - TD and HP
• Calculation of process lethality
• Biological indicators to be used and how to make the selection
• Laboratory studies needed to support sterilizer studies
• Identification of elements in the process that can affect D-value

Who Will Benefit:

• Manufacturing operations personnel
• QA/QC professionals
• Formulation,product and process development personnel
• Regulatory affairs professionals
• Research and development personnel
• Sterility assurance team members
• Technical operations personnel
• Validation professionals