Analytical Services

ROBUST ANALYTICAL TECHNIQUES & PROCESSES FOR QUALITY ASSURANCE

Starting with incoming materials and progressing to finished products, we offer a comprehensive range of analytical services to ensure stringent quality assurance and the expertise to execute them with the highest level of precision and care. Doing otherwise is not an option — quality requirements for injectables are rigorous and, more importantly, our work has a direct impact on patients’ lives.

ADVANCED CHEMICAL, MICROBIOLOGICAL & STABILITY TESTING

Chemical testing at Simtra BioPharma Solutions spans raw materials and active pharmaceutical ingredients, equipment, materials in process, and finished and kitted products. Microbiological testing includes environmental monitoring of classified areas and personnel, sterility testing, in-process bioburden analysis, identification of microorganisms, stock culture maintenance and media release. We also conduct stability studies (follow-up, photostability, compatibility and qualification). 

To perform analytical testing, we make use of chromatography and mass spectrometry, electrophoresis, spectroscopy, light scattering, ELISAs and other plate-based methods, elemental analysis and water content analysis.