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Controlling Microbial Contamination Through ‘Real Time’ Methods for Medical Device Manufacturing

Vicki Barbur  (Senior Director, Strategic Partnerships and IP Commercialization, Battelle)

Location: 210C

Date: Wednesday, February 12

Time: 1:15 pm - 2:00 pm

Track: MD&M Conference: Materials, Testing & Risk Management Solutions

Vault Recording: TBD

Microbial contamination associated events in medical device and pharmaceutical manufacturing are receiving increased attention as part of the need to ensure high quality products. Additionally, there is a need to deploy rapid microbial methods to support lean manufacturing approaches, where time and inventory both contribute to ‘waste’. Battelle has developed the Resource Effective Bio-Identification System (REBS) delivering microbial identification technology that enumerates and identifies microbes using a combination of microscopic imaging and Raman micro-spectroscopy for fast, ‘real’ time output.

Topics covered include:

  • How deploying microbial testing capabilities can support enhanced QC in line/at line for medical device manufacturing needs
  • Reviewing the basic application of Raman Spectroscopy to extract critical data and thereby identify microbes of concern leading to contamination events
  • Hear about results from recent trials and applying lessons learned