In this article, Max van Heeswijk, IT manager at Tjoapack, explores how the digitalisation of pharmaceutical packaging and the broader supply chain, as well as the introduction of smart packaging, can help pharmaceutical companies make their products fit for the future. He also explains how companies can unlock the potential of these new technologies for their projects.
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The global pharmaceutical industry has grown considerably, due to an ageing population and advances in available treatments.
This growth has substantially impacted the pharmaceutical packaging market, which is expected to experience an increase from $135.2 billion in 2023 to $284 billion in 2032, at a compound annual growth rate of 7.72%.
In addition to managing this growth, the pharmaceutical packaging sector must contend with a number of challenges that have the potential to impact how they support drug developers in packaging and presenting finished drug doses in the future. These include compliance with requirements to prevent counterfeiting and support product quality to optimise patient safety.
Understanding market challenges
A number of key market challenges are impacting the design of secondary pharmaceutical packaging:
Serialisation to prevent counterfeiting
Regulatory requirements surrounding patient safety and supply chain integrity are becoming increasingly stringent.
Drug counterfeiting presents a significant risk to patient safety for all drug products, including oral solid dose (OSDs) and injectables. An estimated 13.6% of medicines in low- and middle-income countries are substandard or falsified, with this percentage rising to 19.1% for antimalarials.
Governments have mandated serialisation on all drug units to prevent falsified medicines from entering the supply chain. Legal frameworks, such as the E.U. Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA), phase II, establish the legal requirements for authenticity and traceability. Pharmaceutical companies looking to sell into the U.S. and E.U. The market must ensure that their secondary packaging and broader logistics operation support these requirements, while also helping to ensure optimum manufacturing efficiency.
Ensuring patient safety by supporting product quality
There are also safety issues relating to the chain of custody of drug products - particularly for temperature-sensitive drug products, such as biologics, many of which must be stored and transported at frozen or ultra-frozen temperatures. Pharmaceutical companies need to find ways to support monitoring the temperatures and environmental conditions surrounding their drug product doses during transport. This is to minimise the risk of excursions that could result in affected doses becoming unsafe for patient use, meaning they have to be disposed of, adding to costs.
Digitalisation is key to supporting regulatory compliance and safety
Digitalisation has a crucial role to play in meeting regulations relating to serialisation. Innovative digital track and trace solutions are instrumental in safeguarding patient health by providing end-to-end visibility across the pharmaceutical supply chain. They do this by helping companies assign a serial number to each dose and pack to allow them to be tracked as they move through the supply chain - essential for compliance with U.S. and E.U. regulations. For medicines being transported to and within the E.U. market serial numbers can be inputted into the European Medicines Verification Organisation (EMVO) database, enabling pharmacies to scan packs for verification at the point of dispensing.
This robust system not only prevents counterfeit drugs from entering the supply chain but also allows for rapid and precise traceability in the event of a recall or investigation.
Digitalisation can also support companies in minimising the risk of temperature and environmental excursions that can leave drug doses unviable and unsafe for patient use. With the right digital technology, companies can track their products through the supply chain and monitor the temperature readings from each unit in real time. This can help them find ways to rectify the situation before products are damaged, pinpoint any unviable units and potentially help them identify solutions to prevent issues in the future.
New smart packaging supports digitalisation
The potential for digitalisation success lies not just in having the digital infrastructure in place, new secondary packaging and labelling solutions are also vital.
Smart labels with radio-frequency identification (RFID) or near-field communication (NFC) technology are increasingly being considered to support serialisation requirements for both pre-filled syringe (PFS) and OSD. Compared to traditional labels, these smart labels can provide more robust information, including unique identifiers and serialisation data, which are critical for regulatory compliance and seamless scanning during transport. Furthermore, they can potentially harmonise data systems across the pharmaceutical supply chain and align serialisation compliance with operational efficiency.
Additionally, for temperature-sensitive drug products such as biologics, smart labels with processor cores can enable real-time temperature monitoring during transport. The data can be transmitted to a central database, allowing for the identification and disposal of units with temperature excursions and aiding in future root-cause analysis.
The importance of expert support
In the pharmaceutical industry, the adoption of cutting-edge packaging solutions often requires substantial capital investment, which can be daunting for companies. As a result, many pharmaceutical companies are forging strategic alliances with expert contract packaging organisations (CPOs) with dedicated experience in digitalisation.
Such CPOs can provide ready-made infrastructure to support not just by incorporating smart labels into packaging, but by accessing the digital infrastructure needed to support traceability and real-time monitoring. Leveraging their in-house expertise and partnerships with leading software suppliers, these CPOs are best placed to empower pharmaceutical companies to develop and implement robust digital solutions to meet regulatory and patient safety challenges in the future.