PDA Letter Article

One Company’s Approach to Rapid Micro Methods

by Mousumi Paul and Scott Hooper, Merck Sharp and Dohme Corp.

The Vision and Experience at Merck, Sharp and Dohme Corp.

Microbiology is a relatively old science. Many of the microbiological techniques in use today were developed over a century ago. These techniques include growth-based methods, which assume culturability of organisms, require days of incubation for adequate growth, and depend on visual examination for growth. Rapid Microbiological Methods (RMM) offer answers to a number of business drivers and improvements to existing technologies (Figure1). At MSD, there is an effort to accelerate innovation through migration of conventional microbiological methods to RMM. Some of the drivers and benefits of the rapid methods we are targeting include:

  • significantly reduced time to result (TTR) to support earlier release of product,
  • automation and efficiency to reduce lab costs,
  • improvements in process control with frequent or real-time monitoring, increasing the possibility to intervene earlier in a contamination event, and
  • bringing technology to the shop floor for troubleshooting and aid decisionmaking