Manufacturing

Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.

A flexible filler is a single filling line capable of processing vials, syringes, and cartridges. Traditionally a filling line is designed to process only one container type. By using a flexible filler, the drug innovator or contract manufacturer can decrease capital expenditure, decrease facility “footprint,” improve product and format-parts change over, and reduce product loss.

Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product¹. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.

In Part 1 of our West on the Road – Eschweiler series, we learned about the high-value products produced in our Eschweiler, Germany facility and how this dedicated team of manufacturing experts supports customers in their mission to bring critical medicines to patients. In Part 2, we learn from Lukas Buglowski, Team Lead of Engineering, Envision, about how a focus on quality is both a shared mindset and built into every step of the manufacturing process in Eschweiler. Buglowski shares the pride his team feels knowing that they are producing high-quality products that will not only meet customers’ expectations, but more importantly, ensure patient safety, and how this builds trust and makes for a great team dynamic.

In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.

In 2016, West reached another quality milestone -- ISO 15378 (Primary Packaging Materials for Medicinal Products) certification for manufacturing facilities in North America. These facilities now join the already-certified facilities in Europe and Asia Pacific regions.