In the dynamic landscape of blister packaging, staying ahead of regulatory changes is crucial. As we move into 2024 and beyond, new rules are reshaping how we design, produce, and distribute blister packs.
Whether you’re using custom blister trays for electronics, clamshell blisters for consumer goods, or pharmaceutical blister packs, these updates directly impact your operations.
The environmental spotlight is brighter than ever. In 2024, the EU’s Packaging and Packaging Waste Regulation (PPWR) takes center stage. This landmark rule, set to be fully applicable by mid - 2026, mandates that all packaging, including blister packs, must be designed for recyclability.
Blister materials like PET and PVC now need to meet stringent recyclability standards, ensuring waste can replace primary raw materials in further processing. For example, plastic blister packaging will soon have minimum recycled content requirements, reaching up to 65% for single - use plastic bottles by 2040. Non - compliant blisters risk being barred from the EU market, a significant shift for global manufacturers.
In the pharmaceutical sector, the European Pharmacopoeia Supplement 11.7, released in September 2024, introduced a new chapter on extractable elements in plastic materials for pharmaceutical use (2.4.35). This aligns with the 2022 ICH Q3D guideline on elemental impurities. Pharmaceutical blister pack producers must now demonstrate that their plastic containers and closures, integral parts of blister systems, do not introduce harmful elemental impurities.
This involves comprehensive testing using methods outlined in the new chapter, with recommended limits for extractables soon to be included in general text 5.42 of the European Pharmacopoeia.
Moreover, in the US, the Pharmacopoeia (USP) updated chapter <1031> effective December 1, 2024. Now titled “Biocompatibility of Pharmaceutical Packaging Systems and Their Materials of Construction,” it broadens the scope to cover plastic and elastomeric components, adopting risk - based approaches for material classifications.
This means pharmaceutical blister pack manufacturers need to re - evaluate their material choices and manufacturing processes to meet these new biocompatibility requirements.
Adapting to these regulatory updates is not just about avoiding penalties; it’s an opportunity to innovate. By embracing sustainable materials, optimizing blister designs for recyclability, and ensuring pharmaceutical grade compliance, you can enhance your brand’s reputation and gain a competitive edge.
As the regulatory landscape evolves, those who adapt swiftly will thrive in the market for blister packaging.
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