High-performance ion mobility spectrometry is an efficient technique for cleaning validation

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The rigorous cleaning of manufacturing equipment via well-defined standard operating procedures (SOPs) is one of the pharmaceutical industry’s primary defenses against contamination and adulteration. Cleaning validation confirms the efficacy of such procedures but can present challenges, generating large numbers of samples for analysis and potentially keeping equipment offline for too long, compromising productivity.

This article examines high-performance ion mobility spectrometry (HPIMS) as a technique for cleaning validation, comparing it with conventional alternatives. Experimental data illustrate the linearity, reproducibility, and detection limits of HPIMS for relevant compounds, which offers rapid, inexpensive, high sensitivity, at-line measurement for cleaning validation.

Meeting regulatory requirements for cleaning validation

FDA regulations provide a clear and…

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