Sartorius® Microsart Validation Standard Mycoplasma arginini

Chapter 2.6.7 'Mycoplasmas' of the European Pharmacopoeia requires the validation of robustness and sensitivity under consideration of the sample matrix. Furthermore, it must be shown that the method to be validated generates comparable or better results than the classical culture method. Since the majority of cell culture laboratories are prohibited from culturing mycoplasmas in their own laboratories, assay validation at the CFU level is often not possible in-house. Microsart® Validation Standards are non-infectious and therefore safe to use without risking mycoplasma contamination of the cell culture laboratory. They were titrated to a concentration of 10 CFU/ml, which is the sensitivity limit for NAT-based methods to replace the classical culture method. Mycoplasmas were harvested in the forühen logarithmic phase of growth to avoid an atypically high ratio of dead mycoplasmas and, accordingly, a high GU:CFU ratio. All strains were obtained from the National Collection of Type Cultures (NCTC) United Kingdom,.