Ethylene Oxide Residuals Testing

Sterility Assurance Laboratories, Inc. uses some of the most modern equipment available to perform ethylene oxide (EO) and ethylene chlorohydrin (ECH) residual analysis.  Capillary gas chromatography may be performed using a headspace method for exhaustive extraction, or a liquid extraction method for simulated use. 

EO and ECH residual analyses are performed according to specified standards including ANSI/AAMI/ISO 10993-7 “Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals” or other method requested by the customer.  Analyses can be performed on single-device components or on composite sample-item-portions (SIPs) of an entire device.

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