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CZ Vials, Flip-Off Seals, and FluroTec Stoppers
Particle Analysis FluroTec coating Daikyo Crystal Zenith cyclic olefin polymer
Particles in Parenteral Drug Products - Measuring and Mitigating

By Ranjana Singh

四月 30, 2019

Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.

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Leur Lock Syringes
Analytical Services Particle Analysis
Particles in Intravitreal Injections - Part II

By Susan Dounce

二月 25, 2019

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.

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