Packaging/Delivery Systems. This proposed new general chapter addresses the fitness-for-intended-use functionality requirements of packaging/delivery systems that are intended for injectable dosage forms and that include primary packaging components partially or completely made of elastomeric material. Elastomeric closures, when properly fitted with dimensionally compatible packaging/delivery systems, are intended to protect and contain the package contents while enabling safe and effective product access at the time of use. The function being performed by any single elastomeric closure type is dependent on the packaging/delivery system and may cover more than one functional parameter. A more complete discussion of fitness-for-intended-use testing, as compared to closure functionality assessment in early package development, is presented in Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems ⟨1382⟩ that is being proposed in this issue of PF. Also refer to ⟨1382⟩ for guidance on test samples and their preparation, test sample population size, test procedures, test acceptance criteria (data interpretation), and test outcome reporting.
