Newsletter | March 9, 2023

03.09.23 -- Protect Your Drug By Setting High Standards For Your Packaging

Stopper Functionality: Key Considerations

When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. Discover how to assess the functional performance of the stopper and what key aspects should be considered during the assessment and selection process.

Have You Selected The Right Stopper For Your Lyophilized Drug Product?

A suitable container closure system is necessary to ensure successful lyophilization while maintaining product quality. Component selection is a complex process accounting for multiple variables. Packaging considerations should occur concurrent with drug development, so you can mitigate risk at every step of the drug development process.

Functional Performance Of Stoppers To Support Multipuncture Use

Multidose vials can create efficiency and reduce packaging waste when vaccines are administered to large populations. They also enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight, even for the animal health sector, to accommodate different species and use of various needle gauge sizes.

Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

E&L assessments are multistep processes where you must use knowledge of your drug product and manufacturing process, along with data from vendors, analytical labs, and toxicologists, to demonstrate compatibility between the drug product and any material in contact with the drug product.

Forward-Thinking Innovation Combines Demonstrated Design Success With Expertise In Testing And Raw Material Selection

By combining the demonstrated success of an established design and significant levels of expertise in testing and raw material selection, West has achieved improvements and optimized benefits across the spectrum of packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

Managing Container Closure Related Complexities With Lyophilized Drug Products

Using a comprehensive approach to component selection mitigates risks to fill/finish and lyo processing. With careful and deliberate selection of container closures, there does not need to be a trade-off between manufacturability and product quality and patient safety. Explore key considerations for selecting lyophilization stoppers suitable for each intended use.


100 Years of Being By Your Side for a Healthier World™

In its 100-year history, West has developed and marketed many elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention — a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
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