Development and validation of a protocol for field validation of passive dosimeters for ethylene oxide excursion limit monitoring.

An exposure and analysis protocol is described for the field validation of passive dosimeters for ethylene oxide (EtO) excursion limit monitoring. The protocol calls for the use of a field exposure chamber with concurrent sampling using Tedlar air-sampling bags. The bags are analyzed immediately after sampling by gas chromatography with flame ionization detection (GC-FID). The chamber design allows all monitors to be exposed for the exact same time in the field. The sampling and analysis procedure not only determines the actual concentration of EtO present during the monitor's exposure but estimates if concentrations of EtO vary from point to point in the monitor array during the exposure. In chamber operation, the accuracy of the standard generator used to calibrate the GC-FID was independently verified in the field by the standard additions method. The sampling bias of the sampling train was determined to be -3.5% in the 2.4 ppm to 14.3 ppm concentration range. To estimate the stability of collected EtO samples in Tedlar bags, the rate of EtO loss in the bags was determined to be 0.011 ppm/hr at 2.57 ppm and 0.066 ppm/hr at 8.07 ppm. Sampling bias of the passive methods by additional EtO exposure of the monitors in the closed chamber after sampling and during purging was determined to be +1.5%. The Tedlar bag sampling method with subsequent GC-FID determination demonstrated a coefficient of variation of 1.8% at 2.43 ppm.