Multidose Preservative-Free Container Closure Systems: Developmental Considerations for Sterile Small Molecule Drug Products

摘要

Novel container closure system (CCS) technology may allow multipledose drug products to be marketed without added antimicrobial preservatives to meet clinical and formulation needs. In order to ensure patient safety, however, these CCS must be appropriately validated to ensure that they operate as purported. This article outlines general recommendations for validation studies for CCS intended for use with small molecule drug products.