Back to results
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.
Please Signup/Login to see the full article.Click here