QRM Process

Applying Rapid Microbiological Methods

Giant steps have been taken towards monitoring microorganisms in manufacturing processes, and doing so quickly. Eli Lilly Senior Research Fellow Michael Miller, Ph.D., discussed them at the recent PDA conference in Chicago. Read more here, then download Miller’s presentation slides.

Monitoring microorganisms in manufacturing processes is now a matter of hours rather than days, thanks to technologies new to the market. Many methods do not even require microbial growth for detection, said Eli Lilly Senior Research Fellow Michael J. Miller, Ph.D.

Dr. Miller surveyed improvements in rapid microbiological methods, from CO2 detection and ATP bioluminescence to flow and solid-phase cytometry, at the recent PDA annual meeting in Chicago. For his notes -- a 34-page PowerPoint presentation -- click the “Download Now” button below.

In his talk, Dr. Miller credited FDA’s aseptic processing guidelines and PAT initiative for opening the door to better methods, which he believes will take the industry closer to the "desired future state" for pharmaceutical manufacturing in the 21st Century: real-time quality assurance, better process understanding and control, greater efficiencies and reduced product release time.

GlaxoSmithKline also deserves praise, Dr. Miller said. GSK has gotten the go ahead from FDA to use Chemunex ScanRDI for the microbiological analysis of pharmaceutical grade water, and Pall Corp.’s Pallchek luminometer for the early release of a prescription nasal spray product. The latter effort is the first such approval granted under the PAT initiative.

What is yet to come? Technologies in microarrays, biosensors, lab-on-a-chip and nanotechnology will become commercially available in the next five to 10 years, Dr. Miller believes, taking Rapid Microbiological Methods to the next level.

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