08.23.23 -- Mitigating Particulate Risk For Your Injectable Drug Product

The biologics R&D pipeline is getting more competitive, and the growing regulatory complexity, especially around particulate control, makes the potential to get it wrong significant. Learn about three types of particulates, some of which may not be evident until storage of the drug product.

The draft guidance Inspection of Injectable Products for Visible Particulates is intended to clarify the various areas where controls must be in place for a successful particle control strategy that meets regulatory expectations. This article is a summary of the draft guidance and how it applies to components.

The growth of injectable products is driving efforts to tighten the control of particulate matter in pharmaceuticals. This white paper discusses particulate risks, potential sources, and approaches to control particulates in injectables and review the draft regulatory guidance on the inspection of injectable products for visible particulates.

Choosing high-quality, elastomeric components is an essential part of an effective contamination control strategy, and elastomer manufacturers are leading the industry’s efforts to develop innovative solutions for addressing particulate testing needs with new products.

The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. Review the scopes of USP chapters <787> and <788> since both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.

As drug products increase in complexity, become more specialized, and trend toward self-administration, it is more important than ever to have a reliable drug closure system. West recognizes that sensitive and high-value drug products have a particular need for high-quality components with optimal performance and continuous innovation.