Darrick Niccum / Tim Russell
Technology overview and applicability to pharmaceutical quality systems.
A new family or Rapid Micro Method (RMM), real time viable particle detection based on Laser Induced Fluorescence (LIF), has recently been introduced. Sometimes referred to as optical spectroscopy, these instruments provide the ability to continuously measure for the presence of viable particles in real time. An overview of LIF technology will be presented along with a detailed look at TSI’s implementation in the BioTrak® Real Time Viable Particle Detector highlighting critical instrument performance parameters.
Several application scenarios will be reviewed in the context of current regulatory initiatives such as QbD, ICH Q8, Q9, Q10 and PAT. These applications can form a framework of increased knowledge resulting in a better understanding of the manufacturing process leading to improved product quality in addition to financial benefits.