Bormioli on what full integration track-and-trace really means

Federico Piutti, Innovation Manager at Bormioli Pharma, believes track-and-trace technologies will be far more effective when applied directly to primary packaging, and with information being traced throughout the supply chain

Track-and-trace is more effective when applied from the factory to the end-user

Beyond industry applications, track and trace technologies could be also important — in a patient-centric way — for the final user. Patients would be able to directly access information about the drug they’re going to use. Bormioli Pharma is investigating a comprehensive approach in this area, testing several technologies that aim to facilitate the development of digital-ready primary packaging.

The pharmaceutical industry is destined to change radically during the next decade. As stated by international consultancy giant, McKinsey, several drivers will transform the industry, making it considerably different from the one we currently know.1

First of all, modern drugs will reach many more patients than today; thanks to the emergence of a new middle-class in several developing countries, approximately one billion new patients will gain access to state-of-the-art medications. To serve those who cannot afford medicines, innovative private-public partnerships will create new models.

At the same time, unconventional channels will be put in place to overcome inadequate healthcare infrastructures to reach patients in remote areas.

In developed markets, the vast majority of medical needs will be addressed with generic drugs will be produced and distributed at scale and with great efficiency. Alongside these drugs, integrated solutions that combine diagnostics, devices and drugs will create new business models.

Distribution channels and patient services will also further emerge and expand, especially for geriatric and chronic disease applications, as well as a broad range of new players in home and hospital care delivery, services and nursing. Moreover, the number of partners and handover points will significantly increase.

Alongside these drugs, integrated solutions that combine diagnostics, devices and drugs will create new business models

A key role will be played by technology, innovation and their strategic management. The combination and cross-pollination of new inputs will allow the creation of novel solutions such as comprehensive tracking systems throughout the supply chain, which could provide relevant information for everyone involved, including final users.

To tackle these new challenges, a quantum leap is required; supply chain operators will have to build the necessary infrastructure to make this new scenario both effective and practicable. It will rely on the integration of business and industrial systems, with consumer devices being used to “close the loop.”

Regulatory and compliance issues

Serialisation will be one of the breakthroughs in this new era and is already one of the hottest topics in pharma companies worldwide. The process is also being driven by regulatory and compliance issues. This push comes as a result of rising drug-related criminal activities and supply chain inefficiencies, and aims to address drug counterfeiting and unauthorised parallel supply chains, as well as improving supply chain visibility and facilitating potential product recalls.

In our vision, serialisation could be far more efficient — and ensure an even higher level of safety — when applied to primary packaging.

This will indeed create a closer link between packaging and the available information. Direct serialisation could be the key to enhanced traceability and a more effective way to tackle counterfeiting; primary packaging is the only container that cannot be modified along the supply chain until it reaches the end-user, and is then disposed of or recycled to create a circular economy.

Federico Piutti, Innovation Manager, Bormioli Pharma

Primary packaging serialisation allows tracking to begin at vial or bottle production, providing information throughout the supply chain, from primary packaging producers, manufacturers, distributors, pharmacies, hospitals and other institutions to the end-user.

Multiple benefits can be realised; first, the packaging manufacturer is able to detect anomalies during production, eliminate them and optimise the process; pharmaceutical companies then have access to better packaging, improving their own operations. Moreover, there is a reduced risk of counterfeiting and tampering during distribution, with pharmacies and other institutions being able to track the use of the drug.

From a patient-centric perspective, the progressive implementation of track-and-trace technologies could also ensure considerable end-user benefits

Furthermore, introducing primary packaging serialisation infers the creation of cross-functional teams of packaging, engineering, IT, quality assurance and regulatory affairs experts to ensure seamless implementation. Such a process would necessitate a certain amount of physical intervention, such as packaging line upgrades and additional equipment, as well as modifications involving risk evaluation, mitigation strategy and the subsequent adaptation to inherent risks.2

From a patient-centric perspective, the progressive implementation of track-and-trace technologies could also ensure considerable end-user benefits. Indeed, patients would be more aware and better informed about the therapies they’ve have been administered and have access to more information about the drugs they’re using.

The bigger picture

New serialisation technologies should complement global trends such as blockchain, big data analytics, artificial intelligence, etc. Moreover, considering serialisation in an Industry 4.0 context, further added value could be linked to the development of brand-new business models.

Such innovation also requires a flexible and agile approach; to face these changes, Bormioli Pharma is reviewing its centralised model and working with both internal and external partners — such as start-ups, research centres and universities — to create a productive environment in which to generate new value.

Through product marking, we’re working on the construction of an advanced, non-editable, anticounterfeit tracking solution that can be recognised by both industrial systems — possibly by adapting the manufacturer’s production process to the client’s ones — and by consumer appliances and devices. The complex codes we’re developing are also able to supply a wide range of information, all along the supply chain, right up the end-user.

The technology that we’re experimenting with enhances the marking process and provides higher levels of antitampering and anticounterfeiting compliance

Focusing on ultra-fast pulse laser writing, an innovative technology that has not yet been deeply explored in the pharmaceutical packaging environment, and working in collaboration with the Center for Nano Science and Technology (CNST) at the Istituto Italiano di Tecnologia (IIT) — a research institute that promotes excellence in basic and applied research — our laser marking process will enable us to modify the structure of transparent and semitransparent elements in a highly accurate way. This will mark the drug container with a unique code that provides multilayer information throughout the supply chain.

The technology that we’re experimenting with enhances the marking process and provides higher levels of antitampering and anticounterfeiting compliance. Using this technology, the mark itself is written into the material of the container and not just on the surface.

It takes advantage of the whole volume of the item being mark — whether glass or plastic — allowing the creation of 3D codes that are both compliant with current regulations and, at the same time, can also “hide” more complex information and anticounterfeiting marks, all in the same platform.

These invisible 3D codes and marks could be customised in terms of geometry and response to different sources of illumination, and can be detected using specific light sources or user-friendly vision systems. At the same time, a more common code, such as a QR code or a data matrix, is visible and readable by common industrial code scanners or consumer devices, such as smartphones, to guarantee product information access.

As a result of this process, no external agent can cancel or alter the mark, and the risk of micro-cracks or changes in glass strength is eliminated as the marking process doesn’t produce particulates. Moreover, the technology is highly accurate and reliable.

Laser marking tests have been done with different types of materials, from glass to polymers (PE, PP, PET, COC, COP, etc.), and we’ll continue to evaluate the feasibility of other applications/materials in the future. Laser treatment experiments are currently taking place with Type I and III glass — both amber and flint — and with PET plastic containers.

Driven both by compliance and digitalisation, pharma packaging manufacturers are investing considerable resources into the development of different track-and-trace technologies, looking for the most suitable solution. We are still at the beginning of the journey; the real breakthrough will emerge from an immersive and distributed approach to innovation.

Only by doing so, in a forum of open dialogue with pharma companies, will it be possible to find a more effective and integrated solution that combines primary packaging, data management platforms and the needs of everyone involved in the supply chain.

References

  1. www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/finding-opportunity-in-uncertainty-a-new-paradigm-for-pharmaceutical-supply-chains.
  2. www.ey.com/Publication/vwLUAssets/ey-pharmaceutical-serialization-compliance-and-beyond/$File/ey-pharmaceutical-serialization-compliance-and-beyond.pdf.

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