10/11 March 2021
Three drafts for new Ph. Eur. chapters on plastic materials have been published for comment in the recent issue of Pharmeuropa 32.2 (the public deadline is 30 June 2020):
The proposed new general chapter give specifications for COC / COP materials, used in the manufacture of containers for pharmaceutical use (for example prefillable syringes). According to Pharmeuropa, they "follow the same structure as other general chapters on plastic materials in Ph. Eur. Subsection 3.1. Materials used for the manufacture of containers". However, two major changes in relation to the existing chapters are introduced in the new text.
Additives. The sentence: “The supplier of the material must be able to demonstrate that the qualitative and quantitative composition of the type sample is satisfactory for each production batch” as currently stated in other Ph. Eur. general chapters on plastic materials, has been modified for greater clarity to state that: “The supplier of the material must be able to demonstrate that the qualitative and quantitative composition of each production batch complies with that of the type sample.” (description of ‘type sample’ according to Ph. Eur. general chapter 3.2.2. Plastic containers and closures for pharmaceutical use).
Extractable elemental impurities. This test includes the testing and provides limits for:
It is foreseen that a cross-reference to this new general chapter (2.4.35.) is made in each existing Ph. Eur. text on plastic materials in the future.
In comparison, the new USP Chapter <661.1> Plastic Materials of Construction states: "it is being left up to the material user to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished".
More information can be found on the Pharmeuropa website.