New Ph. Eur. Chapter on Elemental Impurities in Plastic Materials

The general Ph. Eur. chapter 5.20 Elemental impurities includes parts of the introduction and scope of the ICH Q3D guideline (Guideline for Elemental Impurities). As general chapter 5.20 is referenced in the general Ph. Eur. monograph Pharmaceutical preparations, its requirements are legally binding. These requirements cover extractable elements originating from plastic containers and closures for pharmaceutical use.

The plastic materials used in the manufacture of pharmaceutical containers are not directly within the scope of ICH Q3D and as such, are not covered by general chapter 5.20. However, ICH Q3D states that when a review of the materials demonstrates that the container closure system does not contain elemental impurities, no additional risk assessment is required. For these reasons, the Ph. Eur. Expert Group 16 has developed and validated a new state-of-the-art method to assess extractable elements in different plastic materials available on the European market.

The draft chapter of Ph. Eur. 2.4.35 Extractable elements in plastic materials for pharmaceutical use was published in Pharmeuropa. Due to the comments received, the final text now only covers the method for testing extractable elements in plastic materials. Mandatory limit values for extractable elements, which were originally proposed, have not been included in the final version. These limits will be provided as a recommendation in a new general text in section 5 of the Ph. Eur.

The new Ph. Eur. Chapter 2.4.35 Extractable elements in plastic materials for pharmaceutical use will be published in Ph. Eur. Supplement 11.7 (expected to be published in September 2024). According to the announcement, references to Ph. Eur. 2.4.35 will then be included in the general chapters for individual plastic materials, starting with the new texts on COP (Cyclo-Olefin Polymers), COC (Cyclo-Olefin Copolymers) and Styrene Block Copolymers.