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Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance. Explore the performance of West’s 1-3mL and 1mL Long NovaPure plungers versus legacy plungers for pre-filled syringes in autoinjectors.
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Review the details of the draft guidance and the importance of component selection as it relates to establishing a risk-based approach.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.
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The presence of particulate matter (PM) in parenteral drug products is a well-known challenge 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.
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The rising prevalence of chronic diseases has increased demand for the global injectable market. Choosing high quality, elastomeric components is an essential part of an effective contamination control strategy, and elastomer manufacturers are leading efforts to develop innovative solutions for addressing particulate testing needs with new products.
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The draft guidance Inspection of Injectable Products for Visible Particulates is intended to clarify the various areas where controls must be in place for a successful particle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 This article is a summary of the draft guidance and how it applies to components.
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As drug products increase in complexity, become more specialized, and trend towards 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.
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Particulate reduction is only part of the story to reduce risk to the patient, but it is a key initiative for regulatory agencies. To meet these increasing market requirements, NovaPure® syringe plungers are made from the most modern, best-in-class elastomeric formulations with FluroTec® barrier film with industry-leading particulate specifications and which minimize compatibility issues with the drug product.
If you would like to learn more about particulates, specifically understanding and applying the updated FDA guidance: Inspection of Injectable Products for Visible Particulate, in particular the importance of component selection as it relates to establishing a risk-based approach, you can access our on-demand webinar here.
If you would like to explore West solutions to best mitigate particulate risk, please discover more about NovaPure® plungers here.
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