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Container/Closure Integrity Assessment A Compilation of Papers from the PDA Journal of Pharmaceutical Science and Technology (paper ship version)

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Gov. Price: $30.00Member Price: $52.50Nonmember Price: $105.00
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  • Description
  • Table of Contents

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 Integrity Assessment

• 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. Ambrosio
• 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. Ambrosio
• 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 Assessment
• The Effects of Withdrawal and Duration of storage on the Sterility of Multiple-Dose Vials – 1986 by Shirley Tuan Yang and Leon O. Wilken
• Evaluation of Closure Integrity after Multiple Penetrations – 1992 by G.D. Chanana, X. Guo, K.E. Avis, A.M. Fleischner and B.B. Sheth

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