Evaluation of Sub-Visible Particles Originating from Elastomeric Closures ​

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.​