Glass Containers for Pharmaceutical Use

A revised version of the European Pharmacopoeia (Ph. Eur.) chapter 3.2.1. Glass containers for pharmaceutical use has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.

Revised Sections

Glass containers for pharmaceutical use are glass articles intended to come into direct contact with pharmaceutical preparations. Colourless glass is highly transparent in the visible spectrum whereas coloured glass is obtained by the addition of small amounts of metal oxides. The following sections of the Ph. Eur. chapter 3.2.1. have been revised:

• Tests: 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: The approach for determining the maximum transmission limit for coloured glass containers has been modified. The light protection of a coloured glass depends on the wall thickness of the containers. Therefore, it was decided to base the maximum spectral transmission determination and corresponding specifications on the wall thickness instead of the volume and closure system of the containers (closures or flame-sealed containers).

For more information please visit Pharmeuropa online.