Thermal desorption extraction proton transfer reaction mass spectrometer (TDE-PTR-MS) for rapid determination of residual solvent and sterilant in disposable medical devices

Abstract

Thermal desorption extraction proton transfer reaction mass spectrometer (TDE-PTR-MS) has been exploited to provide rapid determination of residual solvent and sterilant like cyclohexanone (CHX) and ethylene oxide (EO) in disposable medical devices. Two novel methods are proposed for the quantification of residual chemicals in the polyvinyl chloride infusion sets with our homemade PTR-MS. In the first method, EO residue in the solid infusion sets (y, mgset-1) is derived through the determination of EO gas concentration within its packaging bag (x, ppm) according to the correlative equation of y=0.00262x. In the second one, residual EO and CHX in the solid infusion sets are determined through a time integral of their respective mass emission rates. The validity of the proposed methods is demonstrated by comparison with the experimental results from the exhaustive extraction method. Due to fast response, absolute concentration determination and high sensitivity, the TDE-PTR-MS is suggested to be a powerful tool for the quality inspection of disposable medical devices including the quantitative determination of residual solvent and sterilant like CHX and EO. © 2011 Elsevier B.V.