Plastic Materials of Construction
Recommendation
5/6 May 2026
Challenges and Solutions for Packaging / Devices & Single Use Systems
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The USP chapter <661.1> Plastic Materials of Construction has been changed by a Revision Bulletin. The chapter has been official as of 1 December 2025.
Background and Updates
Plastic Additives and Stabilizers: Comments were received indicating that a revision to the Stabilizers in the Polyvinyl Chloride (PVC) section was needed. Thus the USP Expert Committee changed the specification limit for PVC-Stabilizers (Tin) to max. 1%. The supplier of the material must be able to provide sufficient compositional information to establish whether the material meets the acceptance criteria for additives and stabilizers.
Bisphenol A: The section on Polycarbonate includes a test on Bisphenol A. Bisphenol A is monitored although it is a residual monomer and not an additive. The acceptance criteria is max. 100 µg/g.
More information is available in the USP and in the Revision Bulletins.
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