NovaPure® Syringe Plungers eBook: Chapter 2: Component Design And Manufacture

The integrity of a syringe containment system relies on the seamless integration of design and manufacturing excellence. Within the rigorous framework of EU GMP Annex 1, maintaining sterility is no longer just a goal; it is a regulatory mandate enforced through a comprehensive Contamination Control Strategy (CCS). Shortcomings in component quality can lead to compromised sterility, resulting in costly delays during early-stage development or even post-approval product recalls.

Adopting a Quality by Design (QbD) philosophy allows for the management of quality throughout a product's entire lifecycle. By focusing on critical quality attributes—such as elastomer formulation, rib position, and fluoropolymer barrier films—manufacturers can mitigate risks and ensure reproducibility. This patient-centric approach ensures that every component meets specific quality target profiles, providing the verified evidence needed to satisfy intensifying regulatory scrutiny.