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Equipment Qualification Of Ion Mobility Spectrometry And Method Development And Validation For Pharmaceutical Equipment Cleaning Validation, Amy Lee Heiser
Equipment Qualification Of Ion Mobility Spectrometry And Method Development And Validation For Pharmaceutical Equipment Cleaning Validation, Amy Lee Heiser
Masters Theses
Ion mobility spectrometry (IMS) instrumentation has been identified as a suitable technology for the detection and reporting of drug product and detergent residues from pharmaceutical manufacturing equipment. Ion mobility is not a new technology, but is entering the field of cleaning validation because of tightened requirements from the US Food and Drug Administration (FDA).
The purpose of this thesis is to outline a practical implementation of the analytical technique, Ion Mobility Spectrometry in a cleaning validation program. Ion Mobility Spectrometry (IMS) is fast and specific for the analysis of small organic molecules and has been gaining popularity in the pharmaceutical …