Learning Objectives:

Upon completing this course on radiation sterilization, participants will:

• Understand how to select product polymer materials for optimal product performance after radiation sterilization processing.
• Know how to complete an optimal validation test design – inclusive of dose, dosimetry, sample size, accelerated ageing, ASTM standards, and thermal analysis.
• Understand the effect of product design and assembly on bioburden, product safety and the success in executing the validation journey.
• Understand all the foundations of a successful radiation sterilization program – materials, bioburden, validation, maintenance of validation.
• Understand the impacts of all regulatory guidances on the radiation sterilization process.
• Perform risk assessments effectively.
• Understand where companies miss the mark in triggering, investigating and executing bioburden action levels and quarterly sterilization audits.