Primary packaging container and closures - Solutions from stability to full commercial production (Christa Jansen-Otten, West Pharmaceutical)
Primary drug container that have intimate drug contact are critical in the success of developing and launching new drug products.
Therefore the proper selection of the appropriate container-closure system is key for bringing a product from compatibility trials, stability studies and clinical trials through to industrialisation in a timely manner, as time to market is becoming more and more important within an increasing competitive market environment.
Beside the already demanding requirements for vials and stopper, components for cartridges and syringes must also meet both chemical and functional needs of the delivery system.
Clean modern rubber formulations as well as coated closures are available for sensitive drugs like biopharmaceuticals to minimize interaction and other effects like protein aggregation.
These closures and container/closure systems are available in various formats (i.e., RS, RU) and quality levels depending on customer requirements and preferences.
However, each drug application has unique needs that need to be addressed through the selection of the appropriate primary drug container and delivery system.