The S2 PUMA energy dispersive X-ray fluorescence (EDXRF) spectrometer now comes with a 21 CFR Part 11-compliant software package enabling users to integrate the instrument seamlessly into pharmaceutical laboratory environments for process and quality control. Applications include the analysis of active pharmaceutical ingredients (APIs), product safety measures such as the quantification of inorganic impurities and the analysis of residual compounds from metallic process catalysts. The new software guarantees complete data integrity and authenticity with features such as electronic record keeping, electronic signatures and automatic audit trails. The complementary instrument qualification and operational qualification package (IQ/OQ) further supports users in the pharmaceutical industry. With its HighSenseTM technology, the S2 PUMA can identify and analyse hazardous toxic trace elements and contaminants from production processes according to Pharmacopeia regulation. Samples can be presented as pressed pellets or in powder form, and the instrument can be configured for measurements in vacuum or under helium to suit any application.
