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Research ArticleRESEARCH ARTICLE

Residual Seal Force Measurement of Parenteral Vials. I. Methodology

Dana K. Moron and Nicholas G. Lordi
PDA Journal of Pharmaceutical Science and Technology January 1988, 42 (1) 23-29;
Dana K. Moron
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Nicholas G. Lordi
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Abstract

A quantitative method for measuring the force a closure exerts against a vial finish after sealing is demonstrated using an Instron Constant Rate of Strain Testing Machine. By exerting a slow, constant rate of strain on the sealed vial, a stress vs. time curve is generated which can be correlated to the closure's “residual seal force.” A linear relationship is demonstrated to exist between residual seal force, as measured using the Instron, and the degree of closure compression exerted upon vial sealing. The Instron method is shown to be applicable to a variety of closure sizes and shapes. Residual seal forces for molded, tubing, and standard flat finish vials are compared. This new Instron technique is compared to a method of residual seal force measurement using the commercially available West Seal Force Tester.

  • Received October 12, 1987.
  • Accepted November 24, 1987.
  • Copyright © Parenteral Drug Association. All rights reserved.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 42, Issue 1
January-February 1988
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Residual Seal Force Measurement of Parenteral Vials. I. Methodology
Dana K. Moron, Nicholas G. Lordi
PDA Journal of Pharmaceutical Science and Technology Jan 1988, 42 (1) 23-29;
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  • Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
  • Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
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Residual Seal Force Measurement of Parenteral Vials. I. Methodology
Dana K. Moron, Nicholas G. Lordi
PDA Journal of Pharmaceutical Science and Technology Jan 1988, 42 (1) 23-29;

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