When Do I Really Need to Perform an Ethylene Oxide Requalification?
Overview:
One of the first questions that comes to mind after completing an EO sterilization qualification is, “When do I need to perform a requalification study, and what will that study entail?” Maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired SAL is of utmost importance. This presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification.
Attendees will learn:
• Regulatory background and industry expectation for annual requalification activities of an EO processes
• Verifying and maintaining the effectiveness of an EO sterilization process
• Proper routine assessment of process and equipment changes
• Change assessment strategies with regards to product design, packaging design, and loading configurations
Видео When Do I Really Need to Perform an Ethylene Oxide Requalification? канала Nelson Labs
One of the first questions that comes to mind after completing an EO sterilization qualification is, “When do I need to perform a requalification study, and what will that study entail?” Maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired SAL is of utmost importance. This presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification.
Attendees will learn:
• Regulatory background and industry expectation for annual requalification activities of an EO processes
• Verifying and maintaining the effectiveness of an EO sterilization process
• Proper routine assessment of process and equipment changes
• Change assessment strategies with regards to product design, packaging design, and loading configurations
Видео When Do I Really Need to Perform an Ethylene Oxide Requalification? канала Nelson Labs
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
The Future of Biocompatibility Testing Might Just be Animal Free!Cleaning Validation Roadmap for Reusable Medical DevicesBiocompatibility Evaluation for Device SubmissionStrategies for Testing Hemocompatibility and Potential Upcoming ChangesCleaning Validations for Reusable Medical Devices & FDA Test TrendsHow to Use Biocompatibility to Evaluate Changes in a Medical DeviceSatisfying ISO 18562 and FDA Biocompatibility Requirements for Breathing Gas Pathways DevicesIf something looks clean, is it really clean? Cleaning validations for reusable devicesEvaluating the biocompatibility of reusable medical devices during their whole life cycleShortages of critical raw materials and managing changes and substitutions - Dennis JenkeAddressing Common Observations in Regulatory Submissions of Chemical Characterization ResultsPackage Validations – Meeting the Requirements of ISO 11607STEM UtahWISE Scientist Stories Megan MoffatRisk Assessment for Potential Elemental Impurities on Drug Products/Medical DevicesDeveloping Contamination Control StrategyThe need for a higher level of identifications in large volume parenteral packaging qualificationsThe production process and qualification of film: A film manufacturer perspectiveA Guide to Emergency Use Authorization of Gas Path DevicesAppropriate uses for Product Sterility Testing – when is sterility testing appropriateUnknowns, TICs, and Identified Compounds Below the TTC