Foreign Particulate Matter Analysis in Pharmaceutical Products

In the pharmaceutical sector there is an increasing regulatory requirement for the characterisation and counting of visible and sub-visible foreign particles in pharmaceutical products. LGC has significant expertise in this area.

Our facilities and capabilities include:

• ISO14644 Class 5 standard (FS 209 Class 100) laminar flow cabinets to minimise contamination of samples
• Extensive methods for the isolation of particulate matter for example manipulation of small particles, filtration and centrifugation
• Optical microscopy with image analysis
• Scanning electron microscopy with EDX for qualitative elemental analysis of particles
• High Resolution SEM with Field Emission Gun
• FT-IR microscopy
• Raman microscopy

Using one or more of these techniques, we are able to count the number of particles present in samples, measure their size, record images and also determine the chemical nature of the particulate matter.

We carry the following tests on a routine basis:

• Particulate Matter in Injections USP <788> (Ph.Eur. 2.9.19, Particulate Contamination: Sub-Visible Particles, ICH Guidelines Q4B)
• Particulate Matter in Ophthalmic Solutions USP <789>

LGC has a proven track record in this field, having investigated numerous problems covering active pharmaceutical ingredients, excipients, final dosage forms, process and packaging materials. We are also experienced in the development of custom methods for the counting and characterisation of foreign matter in pharmaceutical products.