09.16.22 -- How Updated FDA Guidance Impacts Component Selection

United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. Better understand the application of USP <382> prescribed testing to cartridges and syringes, from a mechanical testing perspective.

The draft guidance “Inspection of Injectable Products for Visible Particulates” is intended to clarify the various areas where controls must be in place for a successful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 This article is a summary of the draft guidance and how it applies to components.

Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

It is not surprising that there is still confusion on the extractables and leachables topic. Guidances, where available, do not give step-by-step instructions. And drug products and other drug product contact materials are getting increasingly complex. So, where should you start?

Review the details of the draft guidance and the importance of component selection as it relates to establishing a risk-based approach. We examine the role that the NovaPure® product line can play in component selection including the importance of applying an appropriate test method for particle analysis of components.

To meet the needs of patients, lifesaving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.