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Contamination monitoring on particulate filters

Malvern Instruments has added a new capability to its award-winning Morphologi G3 automated particle characterization system, enabling the fully automated detection, enumeration and size classification of foreign particulate matter (FPM) collected on a filter. Applications range from classifying contaminants in fluids for hydraulic transmission and automotive components, to controlling particulate contamination of pharmaceutical materials for injection or inhalation.

Analysis of FPM on filters has traditionally been the preserve of manual light microscopy. Now, the Morphologi G3 brings fully automated image analysis to accelerate characterization and remove any operator subjectivity. As well as generating fast, reproducible results, Morphologi G3 provides large amounts of information about each individual particle, allowing detailed investigation, troubleshooting, and process and quality control.

Several different sample carriers are available for mounting prepared filters of different sizes on to the Morphologi G3. These allow two filters to be presented and analyzed successively with no manual intervention. Essential for automated analysis is their ability to hold the filter paper stretched flat.

The FPM application is fully controlled via the system software through the Standard Operating Procedures (SOPs). Full automation of the Morphologi G3 using SOPs eliminates any user bias inherent in manual microscopy methods. SOPs also allow straightforward method development and easy electronic transfer. FPM are measured, down to 2 µm in size, in a short time, and are automatically classified into specified size brackets.

Automatic calibration, conformance to 21CFR part 11 requirements and the availability of full IQ/OQ documentation ensure that the Morphologi G3 is accurate and repeatable and all data is secure and validated.