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Abstract:  Container-closure integrity provides assurance that compounded sterile preparation quality attributes are met throughout its shelf life. Since compounded sterile preparations lacking container-closure integrity are considered adulterated as per the Federal Food, Drug and Cosmetic Act and are therefore unsafe for patient use, compounders must be able to produce a well closed sealed vial. Furthermore, 503B outsourcing facilities must qualify the capping process as described by the proposed “Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act Guidance for Industry.” This article is the second in a series describing vial crimping and capping equipment selection and the qualification necessary to create a well-closed sealed vial in a Current Good Manufacturing Practice environment to ensure patient safety and maintain compliance.

Related Keywords: Doral (Neal) O. Higgins, Melanie J. Prudom, MBA, Amy Summers, PharmD, BCSCP, container-closure integrity, container-closure system, U.S. Food, Drug and Cosmetic Act, vial sealing, compounded sterile preparations, capper devices, crimper devices, vial-capping qualification process, installation qualification, operational qualification, performance qualification, drug safety

Related Categories: LEGAL, PACKAGING, STERILE PREPARATIONS, QUALITY CONTROL

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