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Chemical Durability of Glass—Delamination

  • Holger Roehl
  • Philippe Lam
  • Dominique Ditter
Chapter
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 38)

Abstract

Primary packaging containers used for the storage of parenteral drugs are designed to protect the medicinal product from the environment to ensure patient safety. Mainly borosilicate glasses are leveraged as the vial material of choice due to their excellent chemical durability and other additional benefits. Nevertheless, the formulation and its excipients can interact with the glass leading to an alteration of the surface. This interaction can result in ion leaching or glass corrosion. One prominent example is the occurrence of delamination which is the formation of glass flakes/lamellae. Such visible particles were the reason for several recalls within the last years. For that reason, an overview of general interaction mechanisms of the formulation with the glass surface and the root cause for delamination is presented within this chapter. Factors influencing the risk for delamination are discussed in detail as well as analytical techniques suited to investigate the impact on the properties of the primary packaging containers. The combination of the knowledge about the underlying root cause and the respective analytical tools to characterize the vial internal surfaces will help both the manufacturers of the vials and the pharmaceutical companies to establish a thorough control strategy to avoid the issue of delamination.

Keywords

Glass Primary packaging containers Vials Chemical durability Leachables Delamination Analytical methods 

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  1. 1.Late Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EUF. Hoffmann-La Roche Ltd.BaselSwitzerland
  2. 2.Pharmaceutical Processing and Tech. Dev., Genentech Inc.South San FranciscoUSA
  3. 3.Site Manufacturing Science and Technology, Validation Engineering & FillingRoche Diagnostics GmbHMannheimGermany

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