Artificial intelligence (AI), blockchain and automation have the potential to streamline the pharmaceutical packaging process and optimise traceability of finished units. The use of new packaging materials can minimise the industry’s carbon footprint. However, as James Bury explains, integrating them into packaging operations poses challenges companies must overcome to harness them effectively.
James Bury, head of Technology at Tjoapack explores the barriers that need to be overcome if the pharmaceutical packaging industry is to benefit from the potential productivity gains offered by artificial intelligence (AI), blockchain and automation.
A number of exciting innovations have begun to gain the attention of companies within the pharmaceutical sector. Artificial intelligence (AI), blockchain and automation all have the potential to streamline the pharmaceutical packaging process and optimise traceability of finished units.
AI, for instance, is now being explored as a means of speeding up drug discovery and development, and minimising the risk of delays or project failures. In addition, it is being harnessed in the drug manufacturing and packaging process alongside other automation solutions to optimise efficiency. Blockchain, meanwhile, shows considerable promise as a means of enhancing traceability of individual drug doses to minimise the risk of counterfeit products entering the supply chain.
On top of this, a renewed industry focus on sustainability is shaking up the sector, with new packaging and filling processes being explored to minimise the segment’s environmental impact.
However, integrating all these advances into packaging operations poses challenges companies must overcome to harness them effectively.
A number of trends are leading the pharmaceutical industry to innovate and introduce new technologies into the manufacturing and packaging process.
Some of the key trends include:
● Personalised medicines and cell and gene therapies (CGTs) are driving demand for smaller batch sizes and more flexible capacity: Due to their nature, personalised medicines and CGTs pose manufacturing efficiency challenges that will need to be addressed. Production lines will have to adapt to smaller, more niche production runs.
This means there will be a need for intelligent packaging processes, with multiple packaging formats. Single-use vials or pre-filled syringes that can accommodate smaller volumes of medication and a wider range of dosages and formulations may become more popular. Due to the higher production costs of personalised therapeutics and CGTs compared with traditional treatments, it is even more important to protect and preserve the medication with solutions such as tamper-evident or specialised temperature-controlled packaging (like RFID chips). As personalised treatments could be delivered directly to the patient — bypassing the clinic or hospital setting — packaging will have to protect them from being negatively affected by various environmental factors.
Personalised medicines will also significantly impact labelling and patient education materials, requiring dosage and formulation information tailored for the specific patient. Ageing patient populations will also need complex information to be delivered in a more accessible manner. Materials will require multilingual delivery via a variety of media, harnessing smart barcode technologies or digitally generated hard-copy booklets describing the patient’s unique treatment regime.
● The drive to optimise efficiency and increase productivity: With the costs of energy, raw materials and manufacturing components on the rise, pharmaceutical companies are having to explore innovative solutions to optimise efficiency and reduce manufacturing expense. This doesn’t just mean exploring alternative sources of vital suppliers, but also rethinking operations and maintenance processes to find more efficient ways of manufacturing their end products.
● Compliance with increasingly stringent serialisation legislation: The updated U.S. Drug Supply Chain Security Act (DSCSA) is due to come into force in November 2023 and it will have enormous implications for packaging and labelling logistics. The new regulation will place more stringent serialisation requirements on pharma companies seeking to ship drug products to the US.
Companies and their contract packaging organisation (CPO) partners will be required to provide interoperable and electronic tracing for products at the package, case and pallet level from this year onwards. To achieve this while minimising the risk of errors or inefficiencies, innovative new technologies will be required.
● Sustainability is rising up the pharmaceutical agenda: Stringent new legislation is being introduced by governments around the world to counteract the climate emergency by requiring companies to minimise their carbon emissions and reduce waste.
This has traditionally presented a challenge to the pharma industry, particularly within the packaging space. It is still difficult to implement new packaging solutions that are workable as well as recyclable or biodegradable. All new formats and materials must be tested for compatibility with drug products and receive regulatory approval.
Despite all this, it will be necessary for pharma companies to revise their approach over the coming years, moving to more environmentally responsible sources of packaging to reduce their carbon footprint.
With these drivers in mind, it is clear that the pharmaceutical industry and its packaging partners must find new solutions to keep pace with the changing market landscape and thrive into the future. A number of advanced technologies have the potential to enable companies to achieve this goal, but also present challenges that need to be overcome if they are to be successfully harnessed:
● Automation can transform line flexibility for the better: With the smaller, more complex batch requirements of personalised treatments and similar new therapies, automation offers the potential to enhance flexibility, ensure process reliability and boost traceability.
Keeping manual interaction with products and packaging to a minimum can prevent human error and reduce waste. Increased automation can also help ensure optimum sterile integrity for products, such as parenterals and ophthalmics, where sterility is a vital requirement.
Automated systems offer an exciting means to streamline supply chain management for package drug products, by enhancing track-and-trace capabilities. They can track and monitor inventory in storage and during transport, helping to reduce waste, improve efficiency and even prevent the risk of counterfeit medicines entering the supply chain.
However, implementing new automation technology requires significant financial investment, which can present a barrier for some companies. This is particularly the case if they cannot find equipment that offers the flexibility they need to manufacture smaller batches. In addition, some packaging processes may be harder to automate. Kitting for injectable drug products is one such example as it can be difficult to ensure the right information is included when manufacturing for multiple markets.
Integration of new automation technologies into existing packaging lines can be an issue, and line operatives must be retrained to operate and maintain new equipment.
● AI can optimise manufacturing and packaging efficiency: AI is already being used in the drug discovery stage on development projects to analyse reams of data to identify potential drug targets, but it offers plenty of scope to transform manufacturing and packaging, too. On production lines, it has the potential to enable effective predictive maintenance — where companies can implement preventative measures to replace or repair components before equipment begins to fail. This can minimise downtime and increase productivity.
Inventory management of finished drug products is another area where AI can more effectively identify potential improvements and ensure that necessary stock levels can be forecast. AI can also be used on packaging lines to detect packaging defects (for example due to product leakage and contamination) that lead to waste and potentially put patients at risk. Deep-learning AI models can offer a more robust inspection compared with traditional image processing techniques. They can learn and adapt to changing environmental conditions, such as different lighting intensities. All in all, AI can help increase packaging line speed, improve quality control and ensure more accurate product count.
● Blockchain can make serialisation more effective: A method of recording information that reduces the chance that a system is altered, hacked or otherwise manipulated, blockchain can optimise efficiency when implementing serialisation. Although not currently required by U.S. law or regulations in other markets, it can be harnessed to make product tracking more secure, with fewer errors.
Blockchain also has the potential to fix global supply chain vulnerabilities, accelerate collaboration among companies, reduce fraud and assure product authenticity.
An Internet of things (IoT)-based supply chain guided by blockchain, for instance, could allow the temperature and location of individual drug packs to be recorded in real time, harnessing wireless sensors and GPS devices attached to the packages. Serial numbers unique to the manufacturer added to the label can then be scanned by the consumer when purchasing the medicine to gain access to all relevant information. The product manufacturer, pharmacy warehouse and the individual pharmacy could also have access to complete, reliable and secure information about the origin and quality of the drugs registered on the blockchain.
Nevertheless, to benefit from blockchain, companies must invest in the software, hardware and connectivity solutions to properly track their products throughout their journey to the consumer.
● New product packages can make the dream of a circular pharmaceutical economy a reality: Although sustainability may be a daunting subject in today’s pharmaceutical space, there are developments that have the potential to bring the concept of a circular economy, where some pharma materials are reused and recycled, closer to reality. For example, drug packaging and containers could be designed for reuse or recycling and waste from drug production could be repurposed or recycled. It’s important to explore options to enable this for secondary packaging and other appropriate drug device components.
However, sustainability is about more than increasing recyclability. It covers a much broader remit, including reducing energy consumption in the manufacturing and packaging process, minimising waste and changing the industry’s mindset. Pharma companies need to explore all of these areas, looking at how the supply chain behind the drug product and its packaging can be reworked to minimise its environmental footprint.
Although new technologies offer exciting scope to enhance efficiency and flexibility for companies in the future, their implementation does pose challenges that can hinder takeup. Failure to address these challenges could mean that companies are unable to stay ahead of the competition.
To overcome these issues, particularly those related to integrating new technology into packaging processes, it is important to reach out to specialist CPOs for support.
CPOs are well placed to support the industry in harnessing the power of new technology to enhance packaging efficiency. In addition to already having specialist packaging infrastructure installed and ready to go, they also have experts exploring ways to incorporate new technologies into their processes efficiently. They also have the resources already available to invest in innovations such as AI or blockchain early, if they believe their clients can benefit from them. As a result, they are able to provide pharmaceutical companies with the technologies of the future the minute they begin working together.
In addition, CPOs have comprehensive knowledge of the packaging needs of a range of dosage forms, as well as the regulatory environment in a number of key markets. Due to the nature of their role in the supply chain, they can offer the flexibility and capacity to develop customised services that can add real value to pharmaceutical companies.
In recent years, CPOs have grown as an integral component in the pharmaceutical ecosystem, supporting drug developers and their contract manufacturing partners to meet patients’ needs while optimising production efficiency. They offer much more than a simple transactional service; they are an integral strategic partner that can help pharma companies harness new technologies to keep up with trends and thrive in a fast-changing market.
The pharmaceutical landscape is undergoing a rapid evolution. Changing market demands, rising costs and increasingly stringent regulation are all creating new challenges that pharmaceutical companies must overcome if they want to succeed.
Cutting-edge technologies offer potential solutions to address these issues, particularly at the packaging stage, but they will only work if companies are able to access them and incorporate them effectively into their operations. Collaboration with expert packaging partners can help companies achieve this goal, providing them with the knowledge, the infrastructure and resources to stay one step ahead, enabling them to continue providing vital therapies to patients.