This is a collection of selected articles on the integrity assessment of container/closure
systems in drug or biological products and/or medical devices. These articles
originate from the PDA Journal of Pharmaceutical Science and Technology
published from 1985 to 1995 and were selected for inclusion in this
booklet by a team of representative industry reviewers knowledgeable on the
topic of container/closure integrity assessment.
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Table of Contents:
I. Container System
• Container/Closure Integrity of Parenteral
Vials – 1987 by Dana K. Morton
• Residual Seal Force Measurement of
Parenteral Vials.II. Elastomer Evaluation – 1987 by Dana K. Morton and
Nicholas G. Lordi
• Residual Seal Force Measurements of Parenteral
Vials. I. Methodology – 1987 by Dana K. Morton and Nicholas G. Lordi
An Automated Method for Vacuum Testing Pharmaceutical Vials – 1988 by Vincent
Wu and Buckley Crist
• Quantitative and Mechanistic Measurement of
Container/Closure Integrity: Bubble, Liquid, and Microbial Leakage Tests – 1988
by Dana K. Morton, Nicholas G. Lordi, Lydia H. Troutman, and Thomas J.
• Quantitative and Mechanistic Measurement of Container/Closure
Integrity: Viscoelastic Measurements of Elastomeric Closures – 1988 by Dana
K. Morton, and Nicholas G. Lordi
• Quantitative and Mechanistic
Measurements of Parenteral Vial Container/Closure Integrity: Leakage
Quantitation – 1988 by Dana K. Morton, Nicholas G. Lordi, and Thomas J.
• Automated Method for Determining Instron Residual Seal Force
of Glass Vial/Rubber Closure Systems – 1992 by John D. Ludwig, Peter D.
Nolan, and Craig W. Davis
II. Container/Closure In-Use
• The Effects of Withdrawal and Duration of storage on the
Sterility of Multiple-Dose Vials – 1986 by Shirley Tuan Yang and Leon O.
• Evaluation of Closure Integrity after Multiple Penetrations –
1992 by G.D. Chanana, X. Guo, K.E. Avis, A.M. Fleischner and B.B. Sheth