IN MEDICAL DEVICES
FREE SEMINAR FROM SANICHEM LABORATORIES
About The Speaker
Dr. Sani is the Managing Director of SaniChem Resources and laboratory director of Sanichem Laboratory. He holds a Ph.D. in Organic Chemistry and was former Professor of Chemistry at the School of Chemical Sciences, Universiti Sains Malaysia(USM) for 27 years.
He is an expert in environmental chemistry particularly in the area of persistent organic pollutants (POPs) monitoring and analysis including pesticides and PCBs. He has been involved in the analytical testing services as consultant and service provider since 1993.
He is an expert in mass spectrometry and other spectroscopic and chromatographic methods of chemical analyses. He has been providing consultation and services to the industries. He developed the methods of ethylene oxide residues analyses on medical devices and introduce the rate of dissipation/decay analysis to help the medical device manufacturers to safely release their products for export.
This free online seminar will cover three related topics.
Hazard and Chemical Safety to EtO Exposures
Unfortunately, EtO possesses several physical and health hazards that merit special attention. EtO is both flammable and highly reactive. Acute exposures to EtO gas may result in respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis.
Learn more on how to safely handle EtO exposures in this webinar.
EtO Residual Limits as Required in ISO 10993-7
ISO 10993-7:2008 classified medical devices into several categories based generally on allowable limit of EtO residues.
First three general categories are;
1. Limited Exposure Devices.
2. Prolonged Exposure Devices
3. Permanent Contact Devices
Beside these 3 categories, there are medical devices which will not or difficult to comply with the set allowable limit.
Learn more about the regulation of EtO Residuals in this webinar.
EtO Residual Analysis in Medical Devices
Ethylene oxide residuals analysis is used to identify and qualify ethylene oxide, ethylene chlorohydrin and ethylene glycol by gas chromatography. The technique helps manufacturers demonstrate the safety of products sterilized by ethylene oxide by determining compliance with accepted residual limits.
Learn more about how SaniChem Laboratories can help you with your EtO Residual Analysis.