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GUIDE TO

Make confident operational decisions by understanding your microflora

Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.

The newest revision to regulatory guidance Annex 1 illustrates more stringent contamination control requirements; it is now a regulatory expectation for manufacturers to implement comprehensive and reliable contamination control strategies. Environmental monitoring (EM) programmes can help keep you compliant, measuring the state of control of production and ensuring product safety. Central to these programmes is accurate microbial identification (ID). When bacterial or fungal isolates are recovered, it is important to correctly identify them as this supports confident operational decisions, a robust tracking and trending programme, and robust risk assessments.

Accugenix® provides relevant and compliant microbial libraries that enable manufacturers of all industries to obtain accurate species‑level identification. Our Accugenix microbial databases are consistently updated as we continue to identify isolates and stay up to date with the evolving microbial world. All of Charles River’s global Accugenix laboratories offer identifications through our AccuGENX‑ID® DNA sequencing service and AccuPRO-ID® MALDI-TOF service. Pharmaceutical, medical device and consumer care manufacturers should not only identify microorganisms found in their facilities but also understand how their microflora could impact manufacturing processes, technicians, final product and end users. This knowledge ensures reliable risk mitigation and appropriate adjustments to contamination control strategies.

Download your free copy of the ‘Guide to’ to learn more.