Design of a New Elastomer Formulation for Lyophilization Applications

West and Corning Launch Viridian™ Vials that provide both performance and sustainability to the healthcare industry

There are two major themes that involve primary packaging components in the revised EU GMP Annex 1 issued in August 2023. This recent revision includes: Implementing a holistic Contamination Control Strategy (CCS) Container Closure Integrity (CCI) because a properly seated stopper represents an adequate microbiological barrier. Pharmaceutical manufacturers must develop a CCS detailing the risks and mitigations within their operations, associated with contamination event opportunities with the emphasis being on personnel awareness, quality culture and controls, with focus on the principles involved in the protection of sterile product during the manufacturing, packaging and distribution processes.
This is why it is important to consider packaging decisions early in the development process. We will examine how primary packaging materials can impact your CCS and showcase West’s approach to mitigating risk on behalf of drug developers.

Our healthcare industry is evolving. The move from IV to SC injection is being driven by lifecycle management, biosimilar adoption, and the hospital to home trend. Molecules are getting more complex, and patients drive the preference for self-administration resulting in the need for more complex combination product development and quick scale up. We will present innovative solutions to these challenges to help speed up drug development and enable patient choice with: A 2.25mL polymer container system for auto-injectors which protects sensitive molecules A large volume cartridge plunger to enable primary containment within an on-body delivery system A small pack, high quality glass containment system to enable quick delivery in early-stage development