Malvern Instruments's Morphologi G3 automated particle characterisation system can now detect, enumerate and classify the size of foreign particulate matter (FPM) collected on a filter.
Applications include classifying contaminants in fluids for hydraulic transmission and automotive components and controlling particulate contamination of pharmaceutical materials for injection or inhalation.
Analysis of FPM on filters has traditionally been the preserve of manual light microscopy.
The Morphologi G3 now has fully automated image analysis to accelerate characterisation and remove any operator subjectivity.
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 analysed successively without manual intervention.
The ability to hold the filter paper stretched flat is essential for automated analysis.
The FPM application is 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.
FPMs are measured, down to two um 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 the Morphologi G3 is accurate and repeatable and all data is secure and validated.
