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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 first 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, United States Pharmacopeia Chapter <1207>, package integrity evaluation, compounded sterile preparations, vial crimping, vial capping, vial sealing, vial closing, current good manufacturing practice, US Food and Drug Administration, FDA, capper, crimper, external contamination, 503B pharmacies, component supplier quality certification

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

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