SCR has been conducting tests and providing advice for the Medical Device industry since 2007. We provide precise and timely service for our customers to meet their respective production needs.
Ethylene Oxide Residual Analysis
Ethylene Oxide Residual Analysis is SCR's area expertise. Ethylene Oxide (EtO) Residuals Analysis is used in the identification and quantification of ethylene oxide, ethylene chlorohydrin, and ethylene glycol by gas chromatography. This test helps manufacturers demonstrate the safety of products sterilized by EO by determining compliance with accepted residual limits. SCR is the only commercial lab that provides accredited EtO residual analysis in Malaysia and surrounding region.
There are two methods of product extraction for residual analysis which are employed with medical device products, depending on intended device use: exhaustive extraction and simulated-use extraction. Exhaustive extraction is used if all residual EO is potentially available to the patient or user. In an exhaustive extraction, all residual EO available must be extracted from the device. Limited use extraction is used to duplicate patient/user contact with the device.
A full dissipation profile for the sterilized article can be determined and will enable a manufacturer to determine the point in time at which the product will be within the established limits for purposes of product release. This is performed by periodic sampling and analyses of the product at a minimum of 3 time points.