Updated Ph. Eur. Chapter on plastic containers

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

A revised version of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa, Issue 31.4. The deadline for comments is 31 December 2019.

In the revised version the list of commonly used polymers has been replaced with a cross-reference to "Materials used for the manufacture of containers" (Ph. Eur. 3.1 and subsections) to take into account additional materials that will be included in the future (e.g. 3.1.17 "Cyclo-olefin copolymers (COC)" and 3.1.18 "Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations", as previously announced in the Ph. Eur. Work Programme of March 2019). In addition, editorial changes have been made throughout the general chapter, including a change in the French title.

Furthermore, in August 2019, a new Ph. Eur. Chapter with the title: 2.4.35 "Extractable elements in plastic materials for pharmaceutical use" has been announced to be elaborated (in the "Update to the work programme of the European Pharmacopoeia").

Following your registration to Pharmeuropa online you will have access to the full Ph. Eur. draft for 3.2.2. "Plastic containers and closures for pharmaceutical use".