Selecting Container Closure Components With Confidence: A Data-Driven Approach To Container Closure Integrity

Brief overview introducing an embedded video. 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.” 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

Closure Integrity • Packaging