BioMérieux culture media simplify pharma industry testing

GMP regulations require that pharmaceutical companies regularly verify the sterility of their production processes for injectable medical products such as vaccines, insulin, intravenous fluids or therapies. MFT are used for this microbiological control. They simulate the normal manufacturing conditions by replacing the product with culture media. Current practice requires the manual reading of several thousand containers filled with this culture media for each MFT. Since each container must be checked individually, this practice is time-consuming and can potentially lead to errors.

BioMérieux has pioneered the two dehydrated culture media for use in MFT. Both are TSE-free to prevent any risk of transmitting bovine spongiform encephalopathy. TSB 3P with vegetable peptones features a patented colour indicator that changes from pink to yellow if a bacterial contaminant is present. This visual indicator simplifies the interpretation of the test result and reduces the possibility of errors. In addition, the vegetable peptones will suit pharmaceutical companies that have animal-free production processes.

‘Simulating sterile filling is critical for our pharmaceutical customers,’ said Alexandre Mérieux, BioMérieux’s corporate vice president of industrial microbiology. ‘This new range of MFT products deliver quality advantages and greater ease of use. It also complements BacT/ALERT, our automated solution for in process sterility control.’

The TSB 3P range with animal or vegetable peptones meets the highest performance standards and complies with US, Japanese and European pharmacopoeias for the growth of non-fastidious microorganisms (bacteria, yeasts, fungi and certain anaerobic bacteria). Both formulations are cold-filterable to avoid any warming step to dissolve the dehydrated medium, and gamma irradiated to ensure the absence of viable microorganisms and mycoplasma. www.biomerieux.com