In vitro diagnostics and microbiological control company bioMérieux is expanding its culture media expertise centre in Craponne, France, with a dedicated b6m manufacturing unit for its biopharmaceutical customers.
Equipped with cutting-edge manufacturing technologies, the new, fully automated, unit has been built to support product demand and the global launch of the revolutionary LockSure plate. Designed for environmental control in pharmaceutical cleanrooms and isolators, this patented technology secures the lids on culture media to ensure optimal quality, from sampling to results.
‘This new manufacturing unit for Count-Tact and LockSure plates enables us to satisfy our customers’ needs for greater performance, flexibility and innovation,’ said Jean-Marc Durano, corporate vice president, Industrial Microbiology.
‘We now have culture media manufacturing sites in the US and France, entirely dedicated to the pharmaceutical industry, to meet global demand.’
Culture media are critical for quality control and requirements from pharmaceutical companies towards their suppliers are therefore very strict in terms of quality and service. With multiple new manufacturing lines, the Craponne production unit operates in compliance with the FDA cGMP 21 CFR Part 820 (current Good Manufacturing Practices), as well as with bioMérieux’s Corporate Quality Assurance policy and Quality System, which is certified ISO 9001:2008 and EN ISO 13485:2003.