Evaluation of Sub-Visible Particles Originating from Elastomeric Closures
This presentation, given at PEGS Boston, describes a collaborative study conducted by West and KBI.
The need to not only quantify sub-visible particles but also to characterize them is a growing requirement from regulators and customers because of the potential to cause patient harm. The USP has sub-visible particles specifications for final product which cover particles >10 um; however current methods are capable of measuring below 10 um and into the submicron range.
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