ISO 10993-7 ETHYLENE OXIDE STERILIZATION RESIDUALS TRAINING

Training Provider in Singapore and Malaysia (HRD Corp claimable)

HRD Corp Claimable Course/SBL Khas No.: 10001356204

​

WHAT YOU WILL LEARN

After attending the training, you will be able to: 

• Understand the requirements of ISO 10993-7 and how to comply to it

• Determine the correct product extraction method for your medical devices 

• Determine the allowable limits for your medical devices according to the latest ISO 10993-7:2008/Amd 1:2019

​

ABOUT THIS COURSE

This training course is designed for the participants to understand the requirements to be met for the determination of ethylene oxide residuals on medical devices. Upon completion of this training, participants will have a good understanding and interpretation of the ISO 10993-7:2008 / Amd1:2019 requirements. There will be a combination of lecture, exercises and practical implementation examples to help the participants to understand the content better.

 

COURSE OUTLINE

• Categorization of medical devices

• Allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH)

• Determination of EO and ECH residuals

• Product release

• Factors influencing product residuals

​

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.

​

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.