White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers

Contamination by an unknown organism often calls for total shutdown of a cleanroom’s operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike.

A new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties.

The white paper is available, free, for download by following the company article webpage link on the right hand side of the screen.

“Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves –as well as on the equipment and materials they bring into the environment,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories.

With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist.

“Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified,” Champagne said.

The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times.

As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements.

Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production.