Sterilization of Medical Devices
11th September 2008, Radisson SAS Hotel, 8058 Zürich Airport, SWITZERLAND
A 1 day educational event offering industry expertise on critical topics to success in medical devices sterilization and to ensure the safety of product for end-user. Professionals of the Medical Devices and Pharmaceutical sector will be present at the only seminar in Switzerland to describe major sterilization methods including demonstrating the latest requirements and changes.
The seminar offers an opportunity for industry to understand the basics, interpretation, application & being update with recent changes between international and European standards. The seminar will cover issues related to release of products as microbiological contamination before sterilization, manufacturing environment & risk analyses on sterilized products.
The following subjects will be presented:
- Radiation Sterilization: Explanation on the changes, update and overview of currents regulation ISO 11137-1,-2,-3:2006 “Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
- EO Sterilization: Principles; Consideration to take during product design; Selection of process challenge devices (PCD’s). Changes in ISO 11135-1:2007 and how to apply them: “Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
- Manufacturing process control and Product Bioburden, an overview including requirements of ISO 11737-1:2006 “Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products” and its application during manufacturing and sterilization process
- The ISO 14971:2007 “Medical devices — Application of risk management to medical devices” standard for risk management applied to sterile products: How can ISO 14971 help to understand the risks associated to the development and manufacture of sterile medical devices?
- Shelf Life studies of Medical Devices and Medical Device Packages, presentation of ISO 11607-1:2006 “Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems” 11607-2:2006 “Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes”
- Residue analysis of Ethylene Oxide (EO), Ethylene Glycol (EG) and Ethylene Chlorhydrin (ECH) in Medical Devices and interpretation of the draft version, ISO 10993-7 “Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals”
- Swissmedic: Regulatory news in the sphere of medical devices: Revision of the European medical devices directives (93/42/EWG and 90/385/EWG) by directive 2007/47/EU (Integration of software, clinical datas, linking to other directives f.ex. machinery, definiton of single-use device,…). Revision of the Guidelines on a medical devices vigilance system MEDDEV 2.12-1 rev 5 (Definitions, expressions, timeframe, changement in scope)
- Sterilization with X-Rays: The new Technology for radiation sterilization. Technology, Regulatory issues, FDA acceptance, advantages, industrial realization in Switzerland