Avoiding the presence of visible foreign particles is a core requirement in the manufacturing of pharmaceutical products. Our test laboratory has developed a simple but innovative method that enables the reliable quantification of foreign particles in pharmaceutical powders.
Preparation by Dispersion in Air
Our preferential method of preparation for flowable powders is via the means of a dispersion tube onto a large CN membrane (∅ 150 mm). Following this technique, it is possible to examine ca. 100 mg of powder in a single step, increasing the statistical significance of the measurement.
Preparation by Vacuum Filtration
Alternatively, the primary powder can be dissolved with a suitable solvent and the residue filtered onto a medium sized CN membrane (∅ 47 mm). This method assumes that the foreign particles are insolvable. The technique is particularly suitable for the investigation of metallic and mineral foreign particles ("elemental impurities").
Analysis Method for Foreign Particles
We utilize an optical measuring method based on an imaging scanner, in order to quickly and reliably detect all visible foreign particles. The measurement result is available in two minutes:
Alternatively, we offer the analysis of foreign particles using SEM-EDX. This method can detect the foreign particles while simultaneously typing the material.
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