Selecting a container closure system for a sterile injectable can be a daunting task in early drug development. FDA rightly points out that “a packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another.”1 Drug developers must ultimately prove that the container closure system and its components are suitable for intended use.
The basic principles for determining that the proposed container closure system is suitable are:
- It adequately protects the drug product
- It is compatible with the drug product
- It is composed of materials that are considered safe for use with the drug and the route of administration
- Its integrity performance ensures that the drug product is safe to be administered
When first evaluating and selecting packaging components for drug containment in a vial an initial theoretical assessment of dimensional fit can be executed to predict if each component, the stopper, vial and seal, are dimensionally compatible. Utilizing modeling techniques such as those found in West’s DeltaCube™ Modeling Platform can further enhance predictability through the use of large data sets to examine the underlying statistical dimensions of each component along with variable compression forces required to seal the vial. These methods can provide confidence before Container Closure Integrity Testing is performed to experimentally verify that the components and capping processes for sealing the vial will provide acceptable container closure integrity and ultimately protect the drug product over its shelf life.
1 Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics, May 1999
Key Learning Objectives:
- Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity
- Learn how West is supporting a full vial containment solution with Valor® Glass Vials, NovaPure® stoppers and Flip-Off® CCS (Clean, Certified, Sterilized) seal