Industry Expert Learning Series HRDF SBL Claimable
Ethylene Oxide (EO) Sterilization for Medical Devices (ISO11135)
INTRODUCTION Medical device manufacturing is both demanding and complex. The training course is designed to create better understanding of the Ethylene Oxide (EtO) sterilization process for the medical device manufacturing professionals in Malaysia.
COURSE OBJECTIVE This course will give participants an in depth perspective and practical examples of the EtO sterilization process, such as validation & standard, EtO routine process control, EtO residuals, safety & environmental control, handling EtO gas and biological indicator
COURSE OUTLINE 1. Introduction 2. Requirements for Validation of EO – ISO 11135 3. EO Sterilizer Operation and EO Cycles 4. Getting started on a new Microbiological validation 5. Re-Qualification of EO – requirements of 11135 and TIR 28 6. Other parts of the validation; EO residuals, packaging, etc.. 7. Problem Solving by Groups
Quality and regulatory affairs managers
Technicians involved in the development, manufacturing and packaging of medical devices
iNTERESTED TO FIND OUT MORE? For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347