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Fogging

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

Abstract

The surface properties of primary packaging containers are determining their interaction with the parenteral drug product solution. This is not only restricted to ion leaching or corrosion effects but also impacting adsorption phenomena. The formulation can creep up the walls forming a thin liquid layer on the inside of the containers. This layer is getting visible as product residues on the vial walls after a lyophilization process. This mechanism is known under the term of “fogging”. This chapter describes the underlying root causes and provides measures to avoid the issue.

Keywords

Glass Primary packaging containers Vials Lyophilization Fogging Surface properties Marangoni effect 

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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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