QA/QC Insight: Improving environmental monitoring of cleanrooms

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Cleanrooms, whether they are part of Biopharmaceutical, Pharmaceutical, or Semiconductor industries, are designed to ensure that the concentration of contaminants is maintained within a tightly controlled range.  Companies employ numerous technologies to ensure that cleanroom environments are maintained; however, the most significant challenge is the assurance that these controls are functioning properly.  In order to verify that EM controls are operational and contaminants are not being introduced into cleanrooms, companies rely on comprehensive environmental monitoring (EM) programs.

The key to any EM program is its ability to efficiently identify outlier results in order to allow for prompt investigation and implementation of corrective and preventive actions as required.  Traditional monitoring programs rely on manual documentation of test sites and corresponding results, followed by review of these results on a quarterly or annual basis.  Regulatory agencies such as the FDA, EMA and Health Canada routinely issue warnings to companies for failing to identify atypical values and trends in a timely manner.

Companies must decide on not only the location of monitoring sites but also on the frequency with which to conduct reviews of the data.  By transitioning from a paper-based system to a fully electronic software solution, QC and Manufacturing departments are able to access data in real-time and respond to outliers immediately.

PerkinElmer’s iLAB™ Laboratory Execution System (LES), combined with the data visualization capabilities of the TIBCO Spotfire® platform, provide QA/QC managers with insight into all aspects of their environmental monitoring program. 

Procedures and results are captured within the iLAB LES system.  Cleanroom diagrams and maps are incorporated directly into electronic procedures and instrument results are automatically entered using PerkinElmers’ industry-leading LimsLink™ integration platform. Managers are then able to view all results dynamically using the advanced graphical visualization techniques of the TIBCO Spotfire software platform. 

Results may be plotted using traditional trending techniques or through advanced integration with TIBCO Spotfire’s mapping functionality.  EM results are able to be plotted on a map of the cleanroom in order to provide visual identification of problem areas.  Additionally, all data are fully interactive and allow for real-time filtering and analysis to easily see trends and patterns and identify unanticipated relationships in the results.

Through a combination of iLAB and the TIBCO Spotfire software platform, companies now have access to solutions that not only address the underlying regulatory and compliance issues, but also provide greater insight and understanding of the cleanrooms that are vital to the manufacturing of critical medicines and hardware used by consumers worldwide.

Click here to watch a video presentation showing how the iLAB™ Laboratory Execution System (LES) and TIBCO Spotfire® data visualization and analysis platform team up to deliver a new level of insight and understanding into Environmental Monitoring (EM) programs.