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In Part I of this two-part series, several of the challenges with USP<789> Particulate Matter in Ophthalmic Solutions were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
Packaging material selection is a key consideration in reducing particle loads. The Daikyo Crystal Zenith® Insert Needle Syringe may offer advantages over glass to reduce the risk of protein aggregation.1,2 Finally, FluroTec® barrier film-coated elastomers such as NovaPure® components reduce leachables that could potentially cause stability issues with a protein drug.
To find out more about the packaging and delivery options available for ophthalmic drug delivery, contact your Technical Customer Service (TCS) representative.
For more information please join West at the PharmaED 2019 Pre-Filled Syringes & Auto-Injectors Forum, February 27–28, 2019, at the Metro Meeting Center in Boston, MA.
FluroTec® and NovaPure® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. FluroTec® technology is licensed from Daikyo Seiko, Ltd.Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
A flexible filler is a single filling line capable of processing vials, syringes, and cartridges. Traditionally a filling line is designed to process only one container type. By using a flexible filler, the drug innovator or contract manufacturer can decrease capital expenditure, decrease facility “footprint,” improve product and format-parts change over, and reduce product loss.
<span>Research has been expanding understanding of biological systems at an exciting pace. In parallel, the biotechnology industry has been rapidly evolving as different biological entities (e.g., cellular and gene-based products) are increasingly harnessed as resources and therapeutics. To maximize the global utilization of biotechnology advances and drive further advancement of the industry, standards are needed.</span>
West celebrated 40 years of successful operations in Kovin, Serbia during the month of October 2021. The West Kovin manufacturing facility specializes in the manufacturing of stoppers and plungers for disposable syringes.
We recently announced our partnership with <a rel="noopener noreferrer" href="https://techin-iitpkd.org/" target="_blank">TECHIN – a Technology Innovation Foundation of IIT Palakkad</a> which focuses on assisting innovation and incubation for growing entrepreneurs, to build a Medtech Research Center of Excellence.
<p><strong>Applying metrology–the science of measurement–to the art of medical device design.</strong></p><strong></strong><p><strong></strong><em>The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 1.</em></p>
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