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Identification of the particle sources:

The legal provisions, specifically the USP <788>, prescribe that injectibles fundamentally be free of all visible contaminants. We offer training courses to let your staff practice visual inspections with standard samples.

In addition, the US Pharmacopoeia describes how the size and number of subvisual particulate matter, i.e. ranging from 10 to 50 µm, should be determined. The standard procedure for this analysis is the optical particle counter method, which we offer as well.

Our filtr. AID membrane allows the filtration and testing for foreign particles of any parenteral, particularly inclu-ding emulsions for which the optical particle counter method fails due to its opacity. One of the advantages of our automated Raman spectroscopy is its capability to identify any particle isolated on the filter.




Examples of Investigations:

Troubleshooting in clean production processes

Identification of Particulate Matter - Reject Small Volume Patenteral

Enumeration of foreign particles in parenterals

Service and Training on Filtration and Particle Isolation, Counting

For Reject Parenteral Samples for Corrective and Preventive Action (CAPA)

Particle Contamination Identification with multiple analytical techniques

OOS EXPRESS Service (overnight)



Product Fact Sheets:

Particle Source in Parenterals