Ethylene Oxide Residual Testing

ISO 10993 – 7

Many medical devices require some form of terminal sterilization and often Ethylene Oxide is chosen because it is effective and does not adversely affect many of the materials used to make medical devices.  The use of Ethylene Oxide as a sterilant obligates companies to demonstrate that ethylene oxide (ETO), and it’s common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG), are removed from the product and packaging. 

Pace Analytical Life Sciences offers analytical ethylene oxide residual testing of terminally sterilized medical devices using currently accepted Gas Chromatography (GC) methods:

• Gas Chromatography with Solid-Phase Micro Extraction
• Gas Chromatography using headspace sampling for ethylene oxide (ETO)
• Gas Chromatography water extracts for ethylene oxide (ETO)
• Gas Chromatography water extracts for ethylene chlorohydrin (ECH) and ethylene glycol (EG)

Pace Analytical has also researched and developed new methods, using unique technology coupled with Fourier Transform Infra-red spectrophotometers (FTIR).  These techniques and methods offer better sensitivity (will meet new 4 mg / 24 hour exposure ISO 10993-7 requirement) and improve data turnaround times over conventional residual testing methods.

• Static Headspace FTIR -  Powerful and versatile analytical technique to identify and quantify molecules that can be volatilized (off-gassed) out of your sample by the application of heated nitrogen gas.
• Static Headspace Cell - A proprietary (3M) sample chamber, with exclusive-use licensing to Pace Analytical, which is purged with pure nitrogen and used as a sample and analyte containment area.  The Static Headspace Cell has integrated temperature control which can be used to heat the cell at programmable ramp rates, constant temperatures, or a series of steps.
• Fourier Transform Infra-Red Spectroscopy - A powerful and well-established technology that is able to capture a well-defined fingerprint of materials for both identification and quantification of analytes.  The signal responses in the spectra have the unique ability of subtracting out known interferences to leave behind the spectra of the analytes of interest.
  Residual Ethylene Oxide - Pace Analytical Life Sciences has developed methodology to measure the release of Ethylene Oxide (EtO), Ethylene Glycol (EG), and Ethylene Chlorohydron (ECH) and determine EO testing, residual EO testing and ECH residual testing.  The power of the analytical technique comes through in the ability to measure total residual but also the rate of release of the residual sterilants and degradation products.

Pace Analytical Life Sciences is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.