Blogs

Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal.

West’s Ready Pack™ system with adaptiQ^® products, that are part of the SCHOTT iQ^® platform, enables both small and large customers the convenience and flexibility to purchase small quantities of sterile, high-quality, ready-to-use (RTU) components. Ready Pack system components are packaged separately but tested for use as an integrated system. Designed to support customers throughout small-scale R&D, clinical trials, fill-finish evaluation, and commercial-scale manufacturing, the Ready Pack system is a comprehensive, scalable packaging solution that helps customers get to market faster by making the same high-quality packaging available from start to finish. Ready Pack systems keep up with emerging ISO standards and our Ready Pack offering includes the latest glass packaging formats such as adaptiQ^® clip nest, cup nest, and tray solution.

Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.

Good container closure integrity (CCI) is an essential feature in preserving the sterility of a drug package over its shelf life. How sterility has been demonstrated, however, has changed substantially over the past 30 years. 

In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft) by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.

At the recent 2018 PDA Parenteral Packaging in Rome, Dr. Qingyu Zeng, Principal Scientist in the Scientific Insights Lab in Scientific Affairs & Technical Services, gave a presentation entitled Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.