ADVANCED ISO 11135 ETHYLENE OXIDE STERILIZATION TRAINING (INCLUSIVE OF ISO 10993-7)

Training Provider in Singapore and Malaysia (HRD Corp claimable)

HRD Corp Claimable Course/SBL Khas No.: 10001351505

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WHAT YOU WILL LEARN

After attending the training, you will be able to: 

• Understand the fundamentals of EO sterilization and its impact on product & packaging

• Understand the concept of sterility assurance level

• Understand the requirements of ISO 11135 and how to comply to it

• Learn the step-by-step approach to validate the EO sterilization process for your medical devices

• Determine the extent of activities required for annual requalification

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ABOUT THIS COURSE

This training course is designed for the participants to have a comprehensive understanding of the requirements for the development, validation and routine control of an ethylene oxide (EO) sterilization process for medical devices. Upon completion of this training, participants will have a comprehensive understanding and interpretation of the ISO 11135:2014 +A1:2018 requirements. There will be a combination of lecture, exercises and practical implementation examples to help the participants to understand the content better.

 

COURSE OUTLINE

• Introduction to sterilization

• Sterility assurance level

• Fundamentals of ethylene oxide sterilization

• Product packaging and load configuration

• Overview on product bioburden test and test of sterility

• Biological indicator and process challenge device

• How to prove a sterility assurance level of 10^-6?

• Validation and requalification of ethylene oxide sterilization process

• ISO 11135:2014 +A1:2018 requirements

• ISO 10993-7:2008 / Amd1:2019 ethylene oxide sterilization residuals

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DIFFERENCES BETWEEN 2-DAY FUNDAMENTAL COURSE & 3-DAY ADVANCED COURSE 

The 3-day advanced course includes the interpretation of the ISO 11135:2014 +A1:2018 requirements and has an additional topic on the ISO 10993-7:2008 / Amd1:2019 ethylene oxide sterilization residuals. 

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TRAINER'S PROFILE

Dr. Tan Heng Kean is an experienced consultant who supports medical device manufacturers in sterilization validation. Her areas of specialization include ethylene oxide sterilization validation, gamma sterilization validation, bacterial endotoxins test, bioburden testing, test of sterility, cleanroom validation and environmental monitoring.

 

She has extensive sterilization and microbiological assessment experience in supporting new product development, product design change, material change, raw material supplier change, and manufacturing process improvement. She managed to assist two contract sterilizers in Singapore and Thailand in investigating and troubleshooting ethylene oxide sterilization failure issues.

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Prior to becoming a full-time sterilization consultant and trainer, she was a Staff Microbiology Engineer at Smith & Nephew and QA Technical Manager at Haemonetics. During her tenure, she successfully ensured compliance with sterilization and microbiological testing requirements, with no findings in all regulatory inspections, certification audits and customer audits.  

 

Dr. Heng Kean holds a Ph.D. degree in Healthcare Biotechnology and earned a first-class honors in B.Sc. Biomedical Sciences. She is also a CQI & IRCA certified lead auditor for ISO 13485:2016 & ISO 9001:2015 quality management system.