ISO 11737-1 BIOBURDEN TEST & ISO 11737-2 TEST OF STERILITY TRAINING

Training Provider in Singapore and Malaysia (HRD Corp claimable)

HRD Corp Claimable Course/SBL Khas No.: 10001353393

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WHAT YOU WILL LEARN

After attending the training, you will be able to: 

• Understand the requirements of ISO 11737-1 & ISO 11737-2 and how to comply to them

• Understand the fundamentals of bioburden test and test of sterility

• Understand the differences between ISO 11737-2 and USP <71>

• Determine the correct testing method for your medical devices 

• Learn how to validate the lab testing method for your medical devices 
   

ABOUT THIS COURSE

This training course is designed for the participants to understand the requirements to be met for the determination of bioburden and test of sterility on medical devices. Upon completion of this training, participants will have a good understanding and interpretation of the ISO 11737-1 & ISO 11737-2 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 bioburden test and test of sterility

• The requirements from ISO 11135 (ethylene oxide sterilization) & ISO 11137-2 (radiation sterilization) on microbiological testing

• ISO 11737-2 versus USP <71>: which should I comply to?

• General requirements

• Selection of products

• Methods for determining bioburden

• Validation of the method for determining bioburden

• Microbial characterization of bioburden

• Routine determination of bioburden and interpretation of data

• Maintenance of the method for determining bioburden

• Methods for performing tests of sterility

• Method suitability test (bacteriostasis & fungistasis test)

• Assessment of the method for performing tests of sterility

• Maintenance of the method for performing tests of sterility

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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.