Cleaning validation

In pharmaceutical manufacturing, equipment contamination can come from any of the materials that have been in contact with the surfaces, including cleaning agents and active pharmaceutical ingredients (APIs) from previous runs. Cleaning validation/verification is one of the critical control processes in pharmaceutical manufacturing, and it must be done efficiently.

HPIMS allows for direct on-site analysis of swab samples by thermal desorption. The GA2100 standalone HPIMS instrument is small enough to be wheeled around a facility on a cart, and requires no vacuum pumps or solvents. If a liquid injection is preferred (as it may be if samples are collected by rinsing equpiment in solvent), the thermal desorber can be easily swapped with an electrospray ionization source.

The GA2100 HPIMS instrument analyzes samples in under one minute, which lets facilities detect contamination early and prevents them from wasting time and money creating an unusable product. HPIMS allows for rapid data collection with precise results and linear range of 2-3 orders of magnitude for quantification. Excellims’ VisIonTM software stores compound-specific methods and associated calibration curves for sample quantification.

Once a method and curve has been developed, it is stored in a user-created library and can be instantly recalled by the technician running the instrument. This gives consistency to the analysis and ensures accuracy and precision.