Ph. Eur. Packaging Chapters adopted

Recommendation

21-23 October 2020
Berlin, Germany

Design Control for Drug - Device Combination Products

The following Ph. Eur. Packaging Chapters have been adopted at the November 2017 session of the European Pharmacopoeia Comission:

• 3.1.1.1. Materials based on plasticized poly(vinyl chloride) for containers for human blood and blood components,
• 3.1.1.2. Materials based on plasticized poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components,
• 3.2.4. Empty sterile containers of plasticized poly(vinyl chloride) for human blood and blood components,
• 3.2.5. Sterile containers of plasticized poly(vinyl chloride) for human blood containing anticoagulant solution.

As reported before in Pharmeuropa Draft Chapters regarding PVC, these chapters had been revised to include four new poly(vinyl chloride) (PVC) plasticizers:

- cyclohexane 1,2-dicarboxylic acid, diisononyl ester;
- butyryl tri-n-hexyl citrate;
- tris(2-ethylhexyl) trimellitate;
- bis(2-ethylhexyl) terephthalate.

The revision follows the REACH identification of DEHP (diethylhexyl phthalate) as a substance of very high concern (SvHC). DEHP is currently used as a plasticizer in most PVC materials and containers for pharmaceutical use.

The following two general chapters were also indirectly impacted by the revision:

• 3.1.13. Plastic additives (the list of additives has been updated with the four plasticizers mentioned above),
• 3.1.14. Materials based on plasticized poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion (the quantification of plasticizers (including DEHP) is now performed by GC-MS).

Additionally, the following two packaging chapters have been revised:

• 3.2.1. Glass containers for pharmaceutical use,
• 3.2.3. Sterile plastic containers for human blood and blood components.

These monographs are expected to be published in June/July 2018 in the online version of Ph. Eur. Supplement 9.6. They will be implemented on January 1, 2019.

For more Information please see Pharmeuropa online.