Blogs

West is pleased to announce that its Online Store now offers the ability to request some of West’s elastomeric testing services! In addition to some of West’s highest quality products available ready-to-use in convenient small packs, USP/EP Combined Chemical and Functional testing on elastomers is now available for purchase on the Online Store. Additionally, shoppers who complete a purchase online are granted automatic customer-level access to the newly redesigned West Knowledge Center, offering in-depth technical content and support.

Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal.

West is now celebrating the one-year anniversary of its Integrated Solutions initiative, known as Simplify the Journey™. Throughout 2019, we socialized the program through marketing materials and face-to-face conversations with customers. Now it’s time to reflect on the lessons we’ve learned — and to look forward to the opportunities on the horizon.

Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.

On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.

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.