Sharing the basic science in sterilization
ABOUT US
Founded in 2020, GemsMEDS Sdn Bhd (formerly known as HengTan Sterilization Consultant) aims to support the medical device industry by sharing the science and knowledge in sterilization technology. A good understanding and knowledge in sterilization will help to ensure safe and sterile medical devices are produced, as well as the occupational safety of sterilization operators.
We are approved by HRD Corp Malaysia as a Registered Training Provider.
PRINCIPAL CONSULTANT & TRAINER
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.