The Danger of Poor Clean Room Investigations

How Blaming Common Root Causes Took Precedence over Comprehensive Trending

This presentation will highlight the importance of environmental monitoring and bioburden testing through an in-depth analysis of cleanroom investigations that hampered the ability for a manufacturing site to produce products safely. We’ll look at the common root causes the site initially blamed for the individual events and how a comprehensive analysis of microorganisms could have given the site a better understanding of the problem, enabling them to resolve it and return the site to a state of control more quickly.

We can learn from this mistake. Speaker Jonathan Kallay will address the common root causes that the site blamed so they could close individual event records. He will also show how a comprehensive analysis of the microorganisms observed could have solidified scope of the problem and returned the environment to a state of control faster.

Jonathan (Jon) Kallay is a Senior Technical & Market Development Manager working for the Microbial Solutions product lines.  He is a subject matter expert on microbiological investigations for manufacturing facilities that make regulated products. Jon provides practical laboratory experience to help clients identify the optimal path forward for their labs. Jon received his Bachelor’s degree in biochemistry from Denison University before earning a post-graduate diploma in pharmaceutical microbiology from the University of Manchester.

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