Foreign particulates and contaminants
Foreign Particulate Matter in pharmaceuticals
Within the pharmaceutical sector, there is an increasing regulatory requirement for the characterisation and counting of visible and sub-visible foreign particles in pharmaceutical products from a safety, quality and efficacy perspective.
The presence of Foreign Particulate matter (FPM) in sterile pharmaceutical products can affect their efficacy and safety and recently has been one of the reasons for a major increase in the number of product recalls.
Our techniques for foreign particulates and contaminants
Our facilities and capabilities include:
- ICP-OES and ICP-MS
- FT-IR and PXRD
- FT-IR microscopy
- Optical microscopy with image analysis
- Scanning electron microscopy with EDX
- 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.
Our applications for foreign particulates and contaminants
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>.
- Method 1. Light Obscuration Particle Count Test (HIAC)
- Method 2. Microscopic Particle Count Test
Using one or more of these techniques, we are able to isolate and count the number of particles present in samples, measure their size and shape, record images and also determine the chemical nature of the particulate matter.
We are also experienced in the development of custom methods for the counting and characterisation of foreign matter in active ingredients, excipients, raw materials, final dosage forms, process and packaging materials.
Our expertise in foreign particulates and contaminants
What makes LGC an unparalleled service provider in this field is that we go above and beyond routine identification of foreign particulates and contaminants.
We have a proven track record of success having investigated numerous problems, and we leverage skills across the company in solid state characterisation, elemental and trace analysis, structural elucidation, extractables and leachables and forensics to work with you to determine the source of contamination, and help implement procedures to eliminate or minimise excessive particulate matter.
If you would like further information or have any questions, please contact us