Automated Detection of Foreign Particulate Matter on Filters

The number of international standards relating to Foreign Particulate Matter (FPM) continues to grow steadily, reflecting an increasing awareness of the importance of FPM in numerous industries. Products as diverse as hydraulic fluids and pharmaceutical inhalers are now covered by regulations that adopt or refer to such standards. This article presents data from an automated image analysis method (Morphologi G3, Malvern Instruments, Figure 1) for the fast, accurate, and highly repeatable measurement of FPM contamination on filters. By automating analysis, removing operator subjectivity and enabling the rapid classification of particles into specified size brackets, image analysis delivers significant methodological improvements over conventional manual microscopy.

“United States Pharmacopeia (USP) include USP 788 that specifies acceptable levels of FPM in injectables, and USP 789, which defines limits for ophthalmics.”

The term FPM describes extraneous contaminant particles such as glass, transparent synthetic fibres, stainless steel, rubber, aluminium and plastic that can be introduced at any stage in a manufacturing process or during operation. Such contamination potentially has serious implications. The direct health consequences of particulate contaminants in injectable drugs, for example, include blockage of blood vessels and inflammatory or allergenic reactions. How much impact particulate contamination has in any situation depends on a variety of factors, including the chemical composition of the particles, their size, number and rate of introduction....