Literature DB >> 25035259

A quick test to monitor the delamination propensity of glass containers.

Volker Rupertus1, Bernhard Hladik2, Uwe Rothhaar3, Volker Scheumann3.   

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. © PDA, Inc. 2014.

Entities:  

Keywords:  Delamination test; Glass delamination; Primary packaging

Mesh:

Year:  2014        PMID: 25035259     DOI: 10.5731/pdajpst.2014.00990

Source DB:  PubMed          Journal:  PDA J Pharm Sci Technol        ISSN: 1079-7440


  1 in total

1.  Impact of Vial Washing and Depyrogenation on Surface Properties and Delamination Risk of Glass Vials.

Authors:  Dominique Ditter; Hanns-Christian Mahler; Linus Gohlke; Alejandra Nieto; Holger Roehl; Joerg Huwyler; Michael Wahl; Andrea Allmendinger
Journal:  Pharm Res       Date:  2018-05-23       Impact factor: 4.200

  1 in total

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