Ph. Eur. Glass Containers

The Ph. Eur. chapter 3.2.1. Glass containers for pharmaceutical use has been revised (Issue 13.2). The chapter will become effective as from 1 April 2027.

Chapter Changes

  • A clarification has been added to describe the purpose of tests A, B and C, used to define the glass type and characterise the hydrolytic resistance of the glass.
  • Hydrolytic resistance: Table 3.2.1-1 has been modified to provide more detailed information about each test and its purpose.
  • Spectral transmission for coloured glass containers: The approach for determining the maximum transmission limit has been modified. The light protection or resulting light transmission of a coloured glass depends (among others) on the wall thickness of the containers. Therefore, it was decided to base the maximum spectral transmission determination and corresponding specifications for containers for parenteral preparations on the wall thickness instead of the volume.

More informaton is avalable in the European Pharmacopoeia Online (a licence is needed).

Go back

NEWSLETTER

Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.