Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
Container Closure Integrity
Sterility of parenteral drug products is a regulatory requirement and must be assured during the complete product life cycle. In addition to protection against possible microbial ingress, some drug products may require maintenance of gas impermeability. Assessment of Container Closure Integrity (CCI) is performed during container closure system qualification, drug product manufacture, release, storage and shipment until the end of shelf life. Numerous container closure integrity testing (CCIT) methodologies exist, but there is no preferred method by regulatory authorities. With the revision of USP Chapter <1207>, deterministic approaches are generally favored in order to be independent of the drawbacks of probabilistic testing.