the-development-verification-and-evaluation-of-container-closure-integrity-assessment-of-prefilled-syringes-using-fluore

USP 381_elastomeric_closure_for_injections_rb_notice

method-development-for-container-closure-victor-et-al-november-2017

661_rb_notice

Understanding Container Closure Integrity Testing

Understanding container closure integrity systems, reviewing past observations, and following the regulations and guidance documents are excellent ways to establish a compliant container closure integrity assay. This article describes recent changes to the United States Pharmacopeia (USP) , guidance documents, regulatory observations, common container closure methods, and provides recommendations on developing and validating a compliant container closure integrity test.