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For many pharmaceutical manufacturers, commercial filling lines are simply a part of the manufacturing process. But when a drug is still in development or requires prescreen stability testing for new primary container selection , small-quantity filling can be difficult. To send such quantities to a contract manufacturer or commercial lines, such as isolator or RABs, can be expensive and time consuming.
As the concept of flexible filling evolves, components in sterile bulk and nest configurations will become more common for small-batch campaigns. Bench-top fillers, which can sit on lab tables and be filled either by hand or through limited automation, can help with small-quantity filling requirements. Many manufacturers are also turning to smaller, automated fill-finish units that have interchangeable modules that can accept different primary containers and components for filling, including prefillable syringes, vials and cartridges.
West currently offers several component options including stoppers, seals and syringe plungers in packaging suitable for small-quantity filling. As the market evolves, we’re developing options for more of our products, including Daikyo Crystal Zenith® vials and syringes.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
As global healthcare systems become more heavily reliant on radiopharmaceuticals for diagnostics and treatment, ensuring that the radioactive drug is safely contained for the duration of its shelf life has never been more vital.<br />
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> 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.
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
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