Friday 27 May 2016

Failure Mode Effects Analysis for Filter Integrity Testing

From a more global point of view, the goal of failure mode effects analysis (FMEA) for filter integrity testing (FIT) is to align the risks as closely as possible with its source. This analysis can identify the root cause of the risk and help the quality assurance staff and operators detect the occurrence of a particular deviation. Additionally, the analysis also helps define the adapted level of training to reduce operator mistakes.

Magnus Stering has written an interesting article for Pharmaceutical Processing about the risk assessment of filter testing.

The article identifies risks for achieving a higher level of FMEA for FIT and for improved quality assurance. It can be accessed here.

Posted by Dr. Tim Sandle

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