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

• 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