Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components
The visual inspection of injectable drug product has been a regulatory requirement since 1936¹, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero². Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.³ Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”⁴

Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation that can be paired with any vial blowback geometry.

We are pleased to share that West has received the Distinction Award of the AmCham Singapore CARES initiative, which is a further testament to West’s continued commitment as a good corporate citizen and our contributions on making a positive impact in the communities we serve.