What Is A Sterilization Dose Audit and How Are They Performed?

Why Should You Attend:

Radiation Sterilization is one of the most prevalent forms of terminal sterilization for medical devices. It has a number of benefits over ethylene oxide sterilization and continues to grow every year in application as more pressure is applied by the EPA to consider alternate forms of sterilization to ethylene oxide. At the heart of a radiation sterilization program is the dose audit that demonstrates the continued efficacy of the process for sterilizing the medical devices first validated during the dose establishment or dose substantiation experiment performed during the validation. A well-considered dose audit program allows companies to effectively manage radiation sterilization for a wide variety of products with both Quality and Operations benefitting from the design of the dose audit program. A poorly designed dose audit program will cause constant questions to arise about the sterilization program and the team who manages it.

Areas Covered in the Webinar:

• Preparing for dose audits
• Scheduling dose audits with Production, the Sterilization Processor, and the Micro Lab.
• Test Samples for Bioburden, Sterility Tests, Confirmation Dose
• What is the real amount of time needed from product prep to report generation.
• Performing dose audits
• Ability to deliver the verification dose.
• Confirming the verification dose package configuration, product configuration, dose map, dose range.
• Understanding the bioburden testing correction factors, bioburden extraction volume, product inhibitory factors, and culturing conditions.
• Understanding the media choice, product inhibition, and volume of media used for sterility testing.
• Bioburden Evaluation as part of a dose audit
• Application of correction factors
• Choice of mechanical agitation, agitation time, and eluent.
• Low bioburden products and the consideration for probabilistic evaluations of bioburden.
• Addressing Dose Audit Failures
• Degrees of Failure
• Investigating the Dose Delivery
• Investigating the Product Testing Procedure
• Investigating the Manufacturing Process
• Extending and Contracting the Interval Between Dose Audits
• Determining what factors should be considered when altering the dose audit frequency.

Who Will Benefit:

• Sterilization Technicians
• Sterilization Supervisors
• Operations Supervisors
• Logistics / Planners
• Quality Managers

Martin Byrne
Sterilization Consultant, Sterilization Illustrated

Martin Byrne has over 25 years of experience in the areas of radiation, ethylene oxide, and radiation sterilization including both gamma and ebeam sterilization. He has provided sterilization support for both large, mature medical device manufacturers as well as small startup companies. Currently, he owns Sterilization Illustrated a consulting and training business that provides support in the area of sterilization, microbiology, and controlled environments. An introductory video can be found at his website, www.sterilizationillustrated.weebly.com that will provide further information about Martin.

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