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Research ArticleTechnology/Application

A Quick Test To Monitor the Delamination Propensity of Glass Containers

Volker Rupertus, Bernhard Hladik, Uwe Rothhaar and Volker Scheumann
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 373-380; DOI: https://doi.org/10.5731/pdajpst.2014.00990
Volker Rupertus
1Schott Pharmaceutical Packaging; and
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  • For correspondence: volker.rupertus@schott.com
Bernhard Hladik
1Schott Pharmaceutical Packaging; and
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Uwe Rothhaar
2Schott Pharma Services, Schott AG, Mainz, Germany
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Volker Scheumann
2Schott Pharma Services, Schott AG, Mainz, Germany
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Abstract

Glass delamination has developed as a quality problem for primary packaging containers over the last years. Beside other factors the container production process can contribute to this phenomenon, and it seems mandatory to steer and control the critical parameters. With the Schott Delamination Quicktest, a rapid test method is developed that provides a rough measure for the container-related properties that affect delamination risk in a simple and reliable manner and in a relatively short time span. The application of this testing method minimizes the risk of unexpected corrosion behavior and can be used as a release criterion for the running production.

LAY ABSTRACT: If pharmaceutical products do not match properly with the glass containers used, the creation of delaminated glass flakes can occur. This process is slow and time-dependent and mostly visible after month or years. With the Schott Delamination Quicktest a rapid method is developed that provides a fast measure for a rough indication of a higher risk for a delamination behavior. The application of the test gives quick evidence and can be used as a release criterion.

  • Glass delamination
  • Delamination test
  • Primary packaging
  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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A Quick Test To Monitor the Delamination Propensity of Glass Containers
Volker Rupertus, Bernhard Hladik, Uwe Rothhaar, Volker Scheumann
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 373-380; DOI: 10.5731/pdajpst.2014.00990

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A Quick Test To Monitor the Delamination Propensity of Glass Containers
Volker Rupertus, Bernhard Hladik, Uwe Rothhaar, Volker Scheumann
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 373-380; DOI: 10.5731/pdajpst.2014.00990
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