FPM investigations can be expensive and, on occasion, inconclusive, further complicating decisions regarding product release. Sterile manufacturing has its own unique challenges, and the investigation of foreign particles is very often a concern. The presence of FPM in sterile pharmaceutical products, which as well as affecting efficacy and safety, has recently been one of the reasons for a major increase in the number of product recalls.1
Regulatory requirements are increasing for the characterisation and quantification of visible and subvisible foreign particles in pharmaceutical products. Turnaround times for FPM testing are often critical; companies typically benefit from having dedicated provision for the rapid analysis of samples using a selection of microscopic and spectroscopic techniques. These include:
- Optical microscopy
- Subvisible particulate quantification
- Scanning electron microscopy (SEM) with energy dispersive X-ray spectroscopy (EDX)
- FTIR spectromicroscopy
- Image analysis
The latest instrumentation enables automation for increased throughput and tightly controlled assays. Automated methods have been successfully validated for both residual DNA and residual protein detection, which enhance sensitivity, reduce interanalyst variability and produce the most robust assays possible.
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