Ethylene Oxide Residuals
 Per quality system regulations (QSRs) of the U.S. FDA, ethylene oxide (EO) gas used as a sterilant during the processing of medical devices is classified as a manufacturing material. After manufacture, EO residuals must decline to a safe, low level before a device can be released for sale.
Microtest follows both FDA and ISO guidelines to recommend release levels for different products, analytically testing sample devices at intervals after sterilization. With most devices, it takes approximately 7 days for EO to outgas from the product and attain safe levels.
New clients receive a complimentary ETHYLENE OXIDE RESIDUAL EVALUATION.
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Microtest pioneered industry standards for EO residuals testing in the 1980s. Under our industry-best cGMP, Microtest today validates our medical device testing using higher-standard pharmaceutical guidelines. And our recent $7.5 million capital investment includes a new laboratory dedicated to EO residuals testing, with the addition of more microbiologists to our experienced staff, plus advanced new equipment.
Microtest now performs primary EO testing with a state-of-the-art Agilent 6890 gas chromatograph (GC) featuring electronic pressure control. This allows us to deliver increased accuracy; consistent, reliable results; and faster product release.
If your device contains compounds such as plasticizers, which interfere with conventional GC readings, Microtest is one of the few labs using specialized gas chromatograph/mass spectrograph (GC/MS) equipment to help identify unknown compounds fast.
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