Serialisation — a learning curve, or dangerous high speed bend?
Carton printers and pharmaceutical packers are required to handle secure and complex data files to provide individualised cartons. Atlantic Zeiser’s Jim Kaye looks at the challenges of serialisation.
Serialisation – Multifaceted challenges call for tailored one-stop solutions
The realisation of different national and international requirements for serialisation and track & trace is still one of the biggest challenges in the pharmaceutical industry. Different coding philosophies, specific requirements for aggregation and data handling in different areas of the world, need to be integrated into the packaging process from each single step to the management of the whole production process. Along with the appropriate equipment for encoding, verification and aggregation, the integration of appropriate software-systems that interplay with machinery and integrate into the existing IT-infrastructure is one of the most important aspects for the successful implementation of serialisation.
Machinery may need additional equipment to handle variable data, and variable data is rarely a part of the typical pharmaceutical companies IT infrastructure, so a Data Hub that can liaise between machine production requirements and overall management or ERP controls can be essential once you have more than one line running serialisation. Especially the administration and assignment of codes across multiple production lines or plants running the same products. Something many pharmaceutical companies are not yet prepared for.
Moreover the multitude of different regulations for serialisation from Europe over China to America tremendously complicates the situation. Many pharmaceutical companies have realized that the successful implementation of serialisation mainly depends on the IT-infrastructure. The innovative software solution MEDTRACKER from Atlantic Zeiser for instance can be combined with existing machinery and is able to interact with all common Enterprise-Resource-Planning-Systems.
The broader the range of products or countries of destination, the higher the level of complexity and concern over how or where serialisation should take place.
In many cases cost aspects may be the starting point for considerations. When the production costs per 1.000 cartons and the throughput are the most relevant aspects, the application of codes could take place on sheet-fed presses, folder / gluers, or dedicated coding lines such as the Atlantic Zeiser DigiLine 300. This is commonly being done for the Chinese market as neither expiry dates nor lot information are required for serialisation. Atlantic Zeiser offers a wide range of digital technology that allows you to equip existing machines with fast and efficient encoding equipment, or stand-alone Serialisation systems complete.
For the expected European principle where expiry date and lot information are integral parts of the code, the preproduction of coded cartons in large volumes is rather problematic.
Pre-coding in large quantities may lead to a significant amount of scrapped codes due to the fact that the encoded cartons will face several potential sources of error and damage in the forthcoming processes. All of these losses must be accounted for.
One of the most strategic questions which should to be posed is, “could serialisation be outsourced?”
For large volumes or batches the answer is “partly yes” to pre-encode stock for a batch that will last several days of production (or more) can make good sense. Whereas short runs require more “overs” to cope with losses and then you have the problem of re-assigning or destroying codes from any un-used product.
Where codes are applied by external processors, it is essential to implement a secure exchange of data in both directions and ensure the same number ranges cannot be processed by more than one producer at any moment.
Also the further handling of data for aggregation or reporting to public authorities is a crucial aspect which can hardly be done from outside. In this context the MEDTRACKER software is also a good solution for outsource providers in order to guarantee the reliable forwarding of printed and rejected codes for further processing in the packaging process and reporting.
As an alternative to external carton encoding pharmaceutical companies may decide to install a device for near-line encoding of flat card board cuts or folded cartons in the own facilities to supply several packaging lines from one central point. In order to assure the highest possible process safety and efficiency an appropriate printing-system should be the perfect convergence of elaborate transporting, state of the art high-quality printing, reliable camera inspection and modular serialisation software. DIGILINE Single 450 from Atlantic Zeiser is a fully integrated stand-alone solution for this type of serialisation. In combination with MEDTRACKER the system guarantees the assignment of codes and reliably excludes double serial numbers as well as potential sources of error like operator mistakes or interruptions in production. Alternatively this type of equipment may also be used by the carton maker to deliver product “just-in time” to the packaging site.
For smaller volumes where throughput is not the most crucial aspect and if space in the packaging line is available, serialisation can also take place when the products are already packed into folding boxes. So-called “track & trace modules” are an appropriate solution for late stage encoding. These modules are multifunctional and allow encoding, visual verification and rejection on a very small footprint. MEDILINE T&T from Atlantic Zeiser is one of these solutions and comes with an integrated accumulating conveyor for the easy connection to upstream processes. The transport mechanism with special sliding cams ensures a slip-free and precise transport of different carton formats to ensure constant encoding results. Optionally labels can be applied to cartons.
In either case it is crucial to connect this type of encoding module to a central serialisation system or hub that assures the assignment of jobs and unique codes and allows the management of several packaging lines or even more than one production sites.
Depending on the country of destination the aggregation of packed products to bundles, cases or pallets and the related collection of so-called parent-child relationships need to be taken into consideration. While aggregation is compulsory in the Chinese market and is expected for the US market, the European Union has not yet finally decided on this aspect.
But even if aggregation is not required by law, it has significant advantages for the internal logistical processes like handling of returns, identification of stolen products, recalls and last but not least the forwarding of the correct serial numbers that have come into the market to public or governmental institutions.
The choice between an automatic and manual solution for aggregation once more mainly depends on the general size of production batches. As rule of thumb, the smaller the batch size and the larger the product range, the less worthwhile is a full automatic solution due to increased setup times. But all aggregation processes have one thing in common, the database to store and countercheck the collected information should be seamlessly adaptable for recent and forthcoming legal requirements. MEDILINE CodeCollectM from Atlantic Zeiser is an ergonomically designed workstation for manual aggregation which is equipped with an omnidirectional code scan camera for up to 3 layers for all 1D and 2D barcodes. Thanks to its integrated interface to the aggregation-module of MEDTRACKER this combination opens up a multitude of possibilities: MEDTRACKER consist of dynamically programmed generic database applications which allow the implementation of almost infinite levels of aggregation without subsequent programming. Management of data is however not limited to the packaging process. As mentioned above, manual steps like rework of closed orders, repacking or damaged cases, exception handling or the reprint of labels often need to be carried out in the warehouse and must therefore be mapped by a flexible and customizable software solution for serialisation and traceability.
As you can see the choice of the right place for serialisation in the process chain depends on many aspects, like the batch sizes, the overall production costs and the availability of space in the production environment. For sure there will never be only one ideal solution. It is even possible to have more than one process requirement in the same company. In this context one of the most important aspects is a central, superior software instance like MEDTRACKER that is able to communicate with common ERP-Systems as well as with new and legacy machinery from different manufactures.
For a successful implementation of serialisation it is in any case of paramount importance to analyze as a first step the product range, geographic areas of delivery, internal IT-structure and the dataflow within the company. This knowledge should the base for the formulation and definition of specific requirements. In this regard initial workshops with internal IT-staff and experts from suppliers of machinery and software seem to be more than helpful. Atlantic Zeiser has focused its knowhow on exactly these issues offering state of the art software solutions as well as physical modules for encoding and aggregation.