High performance ion mobility spectrometry (HPIMS) is an inherently fast, high resolution analytical technique offering high sensitivity over a wide linear range for active pharmaceutical ingredients (APIs), detergents, and excipients. Thanks to its small footprint it is accessible for a whole host of settings, particularly GMP production environments. This makes it well-matched to requirements for cleaning validation, a critical activity for pharmaceutical manufacturers.
Cleaning validation (CV) confirms the effectiveness of established procedures to reduce contamination of residues to an acceptable level. Typical CV methods present challenges such as speed, convenience and sensitivity. This paper explores the benefits of using HPIMS as a CV method.
The data in this paper illustrates a number of clear benefits for using HPIMS for cleaning validation.
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