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The pharmaceutical vial capping process; Container closure systems, capping equipment, regulatory framework, and seal quality tests

Mathaes, Roman and Mahler, Hanns-Christian and Buettiker, Jean-Pierre and Roehl, Holger and Lam, Philippe and Brown, Helen and Luemkemann, Joerg and Adler, Michael and Huwyler, Jörg and Streubel, Alexander and Mohl, Silke. (2016) The pharmaceutical vial capping process; Container closure systems, capping equipment, regulatory framework, and seal quality tests. European journal of pharmaceutics and biopharmaceutics, 99. pp. 54-64.

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Official URL: http://edoc.unibas.ch/40968/

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Abstract

Parenteral drug products are protected by appropriate primary packaging to protect against environmental factors, including potential microbial contamination during shelf life duration. The most commonly used CCS configuration for parenteral drug products is the glass vial, sealed with a rubber stopper and an aluminum crimp cap. In combination with an adequately designed and controlled aseptic fill/finish processes, a well-designed and characterized capping process is indispensable to ensure product quality and integrity and to minimize rejections during the manufacturing process. In this review, the health authority requirements and expectations related to container closure system quality and container closure integrity are summarized. The pharmaceutical vial, the rubber stopper, and the crimp cap are described. Different capping techniques are critically compared: The most common capping equipment with a rotating capping plate produces the lowest amount of particle. The strength and challenges of methods to control the capping process are discussed. The residual seal force method can characterize the capping process independent of the used capping equipment or CCS. We analyze the root causes of several cosmetic defects associated with the vial capping process.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler)
UniBasel Contributors:Huwyler, Jörg
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Elsevier
ISSN:0939-6411
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:11 Aug 2016 09:35
Deposited On:11 Aug 2016 09:35

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