ISO 11137 GAMMA RADIATION STERILIZATION TRAINING

Training Provider in Singapore and Malaysia (HRD Corp claimable)

HRD Corp Claimable Course/SBL Khas No.: 10001353195

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WHAT YOU WILL LEARN

After attending the training, you will be able to: 

• Understand the fundamentals of radiation sterilization in depth

• Understand the concept of sterility assurance level

• Understand the requirements of ISO 11137-1 & ISO 11137-2 and how to comply to them

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

• Learn how to establish the sterilization dose and maximum acceptable dose

• Understand the dose mapping concept and calculation

• Understand the differences between Method VDmax, Method 1 & Method 2 

ABOUT THIS COURSE

This training course is designed for the participants to understand the requirements for the development, validation and routine control of a gamma sterilization process for medical devices. Upon completion of this training, participants will have a good understanding and interpretation of the ISO 11137-1 and ISO 11137-2 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 radiation sterilization

• Overview on product bioburden test and test of sterility

• Establishing the sterilization dose (ISO 11137-2)

• Sterilization dose audit

• Establishing the maximum acceptable dose

• Dose mapping

• ISO 11137-1 requirements

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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.