Cleaning validation





ImageOur analytical and R&D scientists develop and validate methods suitable for trace analysis of active pharmaceutical ingredients. We use HPLC methods with UV-VIS detection as well as employ an  innovative  approach that combines HPLC and mass spectrometry (LC/MS). The latter technique offers superior sensitivity as compared to that with UV-VIS detection. Nonetheless, the biggest advantage of LC/MS relies on its specificity since it enables one to observe a mass spectrum for each data point on the chromatogram. This in turn makes it possible to eliminate the error associated with peak identification.
In addition, BioCentrum develops methods for the recovery of APIs from various product contact materials used in production plants, i.e. steel, glass and a range of seal materials.
Last but not least, we provide research on swab sample storage time and conditions varying parameters such as storage lighting and temperature.