Blogs

You are measured by flow.
Not in theory, in reality: line uptime, schedule adherence, release readiness, and whether product leaves the site exactly when it must. When everything works, nobody notices. When one thing fails, everyone suddenly needs answers immediately.

A container closure system(CCS) is an engineered solution to protect drug product. It must maintain sterility, support container closure integrity, and perform consistently within automated fill/finish operations. A comprehensive CCS strategy integrates materials science, equipment compatibility, contamination control, and scalability.

In parenteral packaging, compatibility is often one of the first considerations evaluated during development. However, compatibility alone does not guarantee success. A component may demonstrate acceptable compatibility with a drug formulation yet still introduce challenges if it cannot consistently support manufacturing, assembly, storage, transportation, and administration.

The previous post in this series, Considerations in Design and Development of Novel Combination Drug-Delivery Devices, explored key design and development considerations for novel combination products. In this installment, we take a deeper look at the mechanical engineering phase, highlighting how the West team applies a data-driven, risk-based approach to ensure each device is not only safe and functional, but also engineered to meet the demands of global-scale manufacturing.

As the use of pre‑filled syringes (PFS) and self‑administration devices continues to grow, syringe performance has become a critical factor in managing drug containment risk across the product lifecycle.
While elastomer components may be designed and manufactured to high quality standards, they must also perform reliably within the syringe system—from fill/finish and storage, through global distribution, to final administration by the patient.

In device and packaging development, you live in the space between “possible” and “proven”.