Ethylene Oxide sterilisation is commonly used to terminally sterilise single use medical devices. The increasing regulatory and compliance requirements in the management of sterilisation processes places additional demands on project teams including those involved in the design and development of new innovative products as well as those involved in operational and supply chain improvements and efficiencies. This 1 day course details the compliance requirements and the current industry best practice approaches to validation and product testing using practical examples.
It is designed to provide a comprehensive knowledge of an EO sterilisation validation process, which delivers the required Sterility Assurance Level, Microbiological Performance Qualification and Physical Performance Qualification to ensure repeatability of the routine processing. The course also addresses and explains associated product testing and test method validation for bioburden, product endotoxin, test of sterility, bacteriostasis & fungistasis and residuals. The course explains the impact of design and manufacturing changes on the sterilisation process, associated product testing and gives examples of how these may be assessed and managed through the validation and change control processes. Sterilisation processes are audited regularly by Regulatory Bodies and this course will give a background for preparing for a regulatory inspection. Routine management of the sterilisation process from pre-sterile checks to defining a product release process will be addressed.
This course is available exclusively on an In-House basis