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Particulate contamination – prevention less costly than a recall

16 August 2011 No Comment

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The old adage “Prevention is better than cure!” has always been especially pertinent within the pharmaceutical industry, and these days it applies as much to the manufacturer as to the patient!

A recent article in the Wall Street Journal highlights a spate of FDA warning letters and recalls resulting from particulate contamination of pharmaceutical products. This story illustrates the benefits of having effective quality monitoring tools in place throughout the manufacturing process.

It happens to the best of them

Following a contamination incident it can be exceedingly difficult to ensure a quick and efficient recovery and no manufacturing plant is immune to these problems. Many industries have to perform development and quality control testing procedures that involve enumerating foreign particulate matter (FPM). In the pharmaceutical industry such testing is particularly important, for injectable drugs (USP 788), metered dose inhalers, dry powder inhalers and nasal sprays, for example.

Morphologi G3 makes particulate contamination monitoring easy

Traditional analysis using manual light microscopy techniques has been time consuming and often involves manual detection and sizing of particles. It is also open to subjectivity. The Morphologi G3, however, allows the detection, enumeration and size classification of foreign particulate matter collected on filters, by automated light microscopy. It allows fast, reproducible analysis and provides a vast amount of information on every particle detected.

For a detailed example I can recommend our application note describing Foreign Particulate Matter testing using the Morphologi® G3  which examines the enumeration of FPM in inhaled products.