EO Sterilization Validation / Revalidation per ISO 11135 2019

Topics

• Control software description and suggested documentation (11 elements)
• Key parts of ISO 11135:2014, and its implementation
• BI and PCD number and placement considerations
• Temperature and humidity mapping
• Fractional, Half-Cycle and Full Cycle runs
• Contract Lab Resources, B&F, BIs, residuals, sterility testing
• Pre- and Post (Aeration)- Conditioning
• IQ, OQ, PQs (MPQs and PPQs) test cases
• Revalidation frequency, considerations, and alternatives
• Putting it all together – the Sterilization V&V Test Report.

Who should Attend

• QAE Personnel
• Quality Assurance Departments
• Research and Development Departments
• Regulatory Affiars Departments
• Manufacturing Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Sterilization Personnel
• Software Engineers
• Purchasing Departments
• Marketing Departments
• Everyone tasked with product development, and sterilization / product sterility
• Consultants