Rapid analytical methods are becoming an essential part of a complete program for Microbiological Control and Monitoring of Aseptic Processing Environments, however, widespread use of these technologies is long overdue. The ability to reduce ”time-to-detection" from days to same-shift will provide widespread benefits through reduction in holding times, recalls, and incidence of harm. In addition, the adoption of rapid methods allow new sampling regimes to be more meaningful, effective, and informative for corrective action. These are significant changes that will make pharmaceutical products safer and protect the industry from losses in revenue.
To fully realize the promise of next-generation rapid analytical methods, new collection and sample prep technologies will also need to be adopted. more