Innovating Pharmaceutical Packaging
Michiel van den Berg sheds light on the challenges and opportunities facing the industry as it adapts to new materials and regulatory requirements, offering expert insights into the future of pharmaceutical packaging.
| 3 min read | Interview
Pharmaceutical packaging must do more than simply contain a product; it plays a critical role in ensuring drug stability, regulatory compliance, and patient safety. As new formulations emerge and sustainability goals reshape material choices, packaging technologies must evolve even further.
One area of innovation is multilayer films, which offer enhanced barrier properties compared to traditional monolayer materials. These advanced structures can help protect drugs from moisture, oxygen, and other external factors that could compromise their integrity.
To explore how these materials are being used, along with broader trends in pharmaceutical packaging, we spoke with Michiel van den Berg, Global Head of Product Management for TekniPlex Healthcare. He shares insights on five-layer blown films, the shift to pharmaceutical-grade resins, and the challenges of incorporating recycled content into regulated packaging formats.
How do five-layer blown films compare in terms of oxygen barrier performance to traditional packaging solutions?
Typically, low-density polyethylene (LDPE) is produced via blown film extrusion. LDPE films are utilized to create bags for the bulk packaging of APIs, tablets, capsules or medical components, and to provide a product contact or intermediate layer in rigid sheet laminates such as blister packaging applications.
Owing to the high purity of its pharmaceutical-grade polymers, LDPE is an effective solution yielding minimal interaction between a package and its contents. However, while LDPE provides an adequate moisture barrier, it does not offer substantial oxygen or nitrogen barrier. A five-layer blown film structure adds an EVOH barrier layer between the LDPE layers; the EVOH provides oxygen protection for products that require safeguarding against oxidation, or where a package must retain a vacuum.
Pharmaceutical companies with oxygen-sensitive formulations – especially when oxidation is accelerated in the presence of higher moisture – can benefit from the significantly enhanced oxygen barrier afforded by EVOH; in fact, EVOH reduces oxygen permeation by several orders of magnitude. EVOH also offers exemplary barrier for odour and taste-enhancing excipients, as well as certain solvents frequently used in transdermal applications.
How does PCR content in pharmaceutical packaging comply with EU sustainability standards?
Pharmaceutical-grade resins comply with the stipulations listed in the Pharmacopoeia, which facilitates regulatory work by pharmaceutical companies. It also assures continuity of supply, a Drug Master File (DMF), a change notification policy, and additive-free resins (if required).
The PCR used in pharmaceutical blister films is produced via chemical recycling, which makes it compliant with current EU pharmaceutical regulations. Even if the final Packaging & Packing Waste Regulation (PPWR) provides exemption for medicinal products in terms of recyclability and recycled content, the industry remains highly interested in testing and adopting these solutions, and contributing to the overall drive toward a circular economy.
On the other hand, tablets and capsules containing nutraceuticals, vitamins, and food supplements are not exempt from the recyclability and recycled content requirements. Understandably, interest in incorporating PCR content into blister packaging in these segments has been more pronounced.
What challenges do pharmaceutical manufacturers face when choosing packaging materials?
The most prominent challenge for pharmaceutical companies concerns changes to the composition of the primary packaging material. This is because the composition and materials type are invariably registered in connection with the medicinal product itself. This being the case, if the blister packaging substrates for a previously approved product changes from PVC/Aluminum to PET/PET, re-registration would be required.
How scalable are recyclable blister packages, and are there any infrastructure modifications required in recycling streams to maximize their adoption?
Recyclable blister packs are suitable when recycling streams exist for flexible or semi-rigid packages composed of PET, PP, or LDPE. Given the large presence of flexible and semi-rigid packaging in food and household products, we anticipate that all regions in Europe and the UK will eventually implement such recycling streams.
