Serialisation is already a requirement in some regions and is soon to be adopted worldwide. Craig Stobie, Gobal Life Sciences Sector Manager, Domino Printing Sciences, sets out the benefits of extending such traceability schemes beyond item level to include secondary and tertiary packaging
Keeping track of what is included inside the secondary and tertiary level of packaging is the next major challenge for the industry
Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favourite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.
Against this backdrop, counterfeiters will find it much harder to infiltrate legitimate markets. Even if the packaging and branding look authentic, item-level serialisation will help verify an item’s authenticity. But moving unique products around the world presents its own problems. Items do not move as single units, but in batches on pallets or in cases. Keeping track of what is included inside the secondary and tertiary level of packaging is the next major challenge for the industry. Aggregation is about understanding how accurately to record serialised pack data and build that into a hierarchical structure that records detailed information about each level of packaging.
Serialisation generates huge amounts of data, creating storage and data integrity challenges. Each item consists of two parts – a physical asset and a data asset. The association must remain linked from the moment a unique identity is assigned to a pack right through to the moment it reaches a patient.
This alone requires a modal shift in the manufacturing mind-set, with each pack effectively a unique batch of one. Reconciliation, which has until now been a line side task completed once per batch, will in future need to extend right through the supply chain and be open to interrogation for the life of the product and beyond.
All serialisation schemes decree that all product data must be uploaded to a national or supra-national database against which product IDs will be verified at the point of sale or dispensing. This in turn raises the question of data aggregation (or the establishment of hierarchical relationships at each stage of the packaging process).
It is almost impossible to consider aggregation separately from serialisation
While some of the schemes in play include aggregation as a requirement, others do not. However, it would seem to be a practicable extension of item level serialisation, enabling, for example, the data for each pack in each bundle, and each case on a particular pallet, to be retrieved with a single scan.
Whatever the motivation, it is vital to start planning for aggregation early on in the manufacturing process. It is almost impossible to consider aggregation separately from serialisation. And it is best to start from the foundations upwards, as any attempt to retrofit aggregation after the fact is fraught with difficulties.
Successful aggregation strategies depend on multiple departments pulling in the right direction. It is no longer the case that products can be manufactured in a factory and simply handed over to the distribution department for dispatch. Now, the entire system of production can break down without co-operation between departments and disciplines.
The core challenge of putting a label on a box was resolved many years ago. The hidden challenge is what is going on behind the scenes to get the data to put it onto a box. How producers do all that effectively, taking account of all the stakeholders and without having a negative impact on transport or logistics is fundamental to successful aggregation. In Domino’s experience, up to 80% of conversations in this area revolve around the practical problems of transferring serialised products from the primary packaging line to aggregated products in the secondary and tertiary stages.
The actual mechanics of label application are relatively simple. The problem-solving comes down to discussions on what sort of relationships pharmaceutical manufacturers have with their respective supply chain: recognising who is important, and finding a way to integrate aggregation within their existing set-up. Many manufacturers are comfortable with the technical and mechanical aspects of label application; it is the higher level of consultancy, solving the end user problems of serialisation or aggregation that manufacturers are looking for.
If a pallet or batch has to be de-aggregated, then it generates a huge range of complications in terms of decommissioning serialised numbers
The cost of failure is high. Manufacturers can apply 20 labels a minute, but if a company has a breakdown which means that it has to manually search and de-aggregate 20 pallets, then any speed advantage is irrelevant. What is more, if a pallet or batch has to be de-aggregated, then it generates a huge range of complications in terms of decommissioning serialised numbers. One bad case in the manufacturing process can create a whole world of problems.
Properly implemented, aggregation will save pharmaceutical companies time and money. Automated packaging lines have the ability to pack and label cartons efficiently and accurately. Combine this with a system that enables finished batches and shipments to be interrogated instantly to locate any pack, at any time, anywhere in the supply chain and the appeal of aggregation is instant and abundant.
The core challenge of putting a label on a box was resolved many years ago; the hidden challenge is what is going on behind the scenes to get the data to put it onto a box
Supply chains can be long and complex, with security only as strong as their weakest point. From a brand protection perspective, the ability to spot-check the location of each pack with pinpoint accuracy is compelling, while those charged with delivering supply chain efficiencies will find much to interest them here too.
In terms of data management, aggregation is a very tempting prospect, with the possibility that a single pallet code might be all that is required to hold the data associated with each one of the potentially thousands of packs it contains.
Is aggregation mandatory? The simple answer in most legislatures is ‘no’. In the EU member states for example, the Falsified Medicines Directive (FMD) does not specifically state the requirement to initiate aggregation in the pharmaceutical manufacturing process. But the sector is a global industry so what is not mandatory in one region, may well be in other markets. It doesn’t matter where a product is manufactured, but where it is sold. In many cases, pharmaceutical companies have no idea of the final destination of their products at the point of manufacture, and any country might integrate a mandate for aggregation as part of its crackdown on counterfeit goods.
It doesn’t matter where a product is manufactured, but where it is sold
One cannot demonstrate the complete traceability that many are hoping item level serialisation will bring without knowing where a unit pack is as part of a consignment. It must be traceable through the distribution network, whether as a serialised pack or aggregated pallet. Many consignments are also destined for multiple destinations. A shipment of 100,000 cartons may be destined for two or three overseas markets. Not knowing which pack is contained in which box, the distributor has no way of complying with serialisation. Part shipments can be physically separated on the pallet by hand. A much more efficient method is to control the data via aggregation, enabling producers to identify and report on exactly what is contained inside each pallet or shipment.
By default, aggregation is mandatory, not through any written part of a directive, but through the practicalities of the distribution network. If goods need to be shipped around the world, the end-user, customs officials and importer are all going to want to know which goods are contained in each shipment.
The same principles apply to equipment capabilities for aggregation as for serialisation; printers need to have on-board capability to apply unique information to each aggregated ‘unit’. Establishing hierarchical associations between the unit-of-sale packs in a bundle, bundles in a case, cases on a pallet and so on, enables any party authorised to handle the product on its journey through the supply chain to interrogate precisely which items the batch contains in a single scan.
While speed is not such a significant requirement in code application at aggregation stage, quality and legibility most certainly are; a pallet code is effectively the key to the unique data associated with every single item on the pallet. Just as users have a choice of technologies at item level, so too there are options at secondary and tertiary level. Print and apply labellers are a flexible option, suitable for use at bundle, case or pallet level, while for direct printing onto cases, large character continuous inkjet systems offer a label-free solution.
Print and apply systems have been around for many years, but their footprint and speed continues to improve. An effective and increasingly popular method of label application in the pharmaceutical sector is the corner wrap. Corner wraps are highly recommended by the Healthcare Distribution Management Association (HDMA) in the US and the distribution channel generally ends up dictating the look, feel and position of the corner labelling solution.
The smaller the footprint of the print and apply labelling machine, the easier it is to integrate the technology into existing production lines. The control and positioning of the label is critical for an efficient and reliable manufacturing process. Many manufacturers may be working with two or thee partners to introduce serialisation, so it is vital to understand the mechanics of the equipment they are all working with.
As pallets are normally stored in cramped and badly lit conditions, it is important that labels are easily legible by hand-held scanners
As pallets are normally stored in cramped and badly lit conditions, it is also important that labels are easily legible by hand-held scanners. Corner labels are large enough and accessible enough to be read with comparative ease, providing the aggregation information needed for easy recognition and distribution. Again, any savings in time can be of enormous value to shippers and pharmaceutical companies, so providing the means to read and convey information is as important as correct labelling.
While serialisation has the potential to increase the trust in the brand and manufacturer for medicines of all description, aggregation has the ability to get them to patients in an efficient and orderly manner. Although aggregation is not written into the most pressing legislative deadlines, logic dictates that it will become a requirement sooner rather than later. Implementing serialisation without at least planning for a subsequent aggregation deployment could prove to be a very costly and time-consuming strategy, whereas successful implementation of automated aggregation lines can offer significant benefits.