Regulations that require the serialization of prescription drugs are not only in the pipeline but becoming a reality in many places. In the EU serialization of prescription drugs is compulsory by the 9th of February 2019 – Delegated Regulation (EU) 2016/161. The Drug Supply Chain Security Act (DSCSA) in the USA will make serialization mandatory by November 2017 and requires seamless track & trace procedures to be implemented by 2023.
Find out how to get ready for serialization and dealing with international track & trace processes.
Click on a country to obtain detailed information on the applicable regulations and deadlines.
If you export medication to different regions or prove packaging or printing services to various customers that do so, serialization can soon become a complex challenge because only unique serial numbers are allowed for each product.
In addition, the issued serial numbers must be collected, stored and reported among the logistics chain or to the relevant authorities’ databases.
If you operate multiple production and packaging lines and produce at different sites, you will quickly encounter feasibility problems without the assistance of a centralized serialization software on ISA-95 Level 3 and 4.
MEDTRACKER is a software solution that controls and monitors serialization and track & trace processes. It can be expanded from a single line to site or enterprise level. MEDTRACKER is able to generate and managing unique serial numbers for an arbitrary amount of different products in order to reliably distribute them to multiple packaging lines or production sites.
Thanks to its generic software architecture workflows and coding schemes are defined in a flexible way and can be adapted anytime without need for reprograming.
At the same time MEDTRACKER is a complete production management platform for serialization applications that allows to virtually manage and administrate machines and packaging lines and to virtually adapt their capabilities.
For an effective order management and to map other existing processes MEDTRACKER can be interfaced with common ERP-Systems. In addition MEDTRACKER is ready for communication with external parties via integrated interfaces such as EPCIS.
Among the cited concerns and reservations are the question of integrating ERP systems, simultaneous production management encompassing multiple lines, maintaining production capacity, and compatibility with existing machinery.
Considering it can take quite a while for planning and implementing such a complex project, very little time remains before the imminent introduction of regulations in the EU and the USA.
Each affected enterprise must plan and act well in advance if it wishes to be in a position to serialize products by the cut-off date. A lot of time can elapse from engaging in initial deliberations, performing process analyses, identifying suppliers, to converting and commissioning machinery, training staff and validation.
The recommended first step entails assembling an inter-disciplinary project team, appointing a project leader, and establishing an information management platform. Serialization is a subject that concerns numerous departments from production and packaging design, to purchasing, quality, logistics and IT.
Before the search for a suitable supplier can be initiated, sufficient time should be set aside for thoroughly analyzing the processes that exist inside the company. The outcomes will make it easier to instruct prospective software and hardware suppliers, and identify the best partner. Given that unforeseen challenges are likely to arise in any pilot project, some time should be reserved for contingencies as well. Consideration must also be given to the suppliers’ lead times.
Bottlenecks can occur, for example, if careful plans are made and implemented for the production machinery and software, but not the IT hardware. Alongside other factors, process safe serialization depends on the availability of absolutely fail-safe and resilient servers.
External business partners, such as packaging suppliers and service providers, as well as wholesalers, should also be integrated in the project because they may need to work with your serialized data as well.
The amount of time to be scheduled for the individual phases depends to a large extent on the scope of the project, but in most cases more than a year is likely required. Implementing a serialization project – especially in the case of pilot lines – can sometimes take as long as 15 to 24 months.
Once a serialization project has been successfully completed on a pilot line, further lines can be set up more quickly, especially if uniform standards have been established inside the company.
Introducing serialization and track & trace however does not only present a challenge, but also a major opportunity to optimize the value chain. Having examined every process stage in detail, the implementing enterprise is well equipped to resolve problems and enhance efficiency.
Atlantic Zeiser is a leading provider of sophisticated individualization, serialization and track & trace solutions, which efficiently and seamlessly monitor product movements, securely verify authenticity, and reliably protect against counterfeiters.
Specifically for the pharmaceutical industry we offer system solutions to ensure the compliant, reliable, fast and cost-efficient application of unique security features to individual and mass products. Our solutions consistently bring together the latest machine and printing technologies with intelligent and modular software architecture providing full process safety.
Depending on country of destination and production volumes, we offer a variety of customizable solutions for implementing serialization and track & trace processes.
Atlantic Zeiser develops and produces all the core technologies in-house. You too can benefit from our unique expertise, encompassing hardware, software and ink. These are the tools for building compelling one-stop solutions.
The advantage of coding flat or glued folding cartons with the high performing offline printing systems such as the DIGILINE Versa is the fact that several packaging lines can be supplied from one central point without the need of high investments in the packaging lines themselves.
In addition, complexity in the logistics process can be reduced if late-stage printing (languages, product variations) is carried out in the same working step as this leads to a minimization of packaging variations with significant impact on cost and complexity.
Thanks to the latest state of the art DoD UV-inkjet technology this can now even be done in full color. With regards to permanently decreasing batch sizes in the pharmaceutical industry this two in one approach bears a tremendous potential for cost reduction.
For serialization of filled and closed folding cartons in the packaging lines compact modules like MEDILINE T&T are used.
These modules can be easily integrated in existing packaging lines and code, inspect and if necessary reject the folding cartons in a very small footprint.
Thanks to a real-time connection with the line manager of the MEDTRACKER software, not only the secure exchange of serialization data is guaranteed but also the exchange of all audit relevant information. Even the user management of multiple machine modules can be easily managed in a central way over MEDTRACKER.
The functionality of Track&Trace systems can be extended with additional modules to apply tamper evident labels on the flaps of folding cartons in the same working step in order to comply with the anti-counterfeit regulations of the EU. Other functions like an integrated checkweigher or a “Bollini labeler” complete the range of applications.
If space is limited it is also possible to integrate the necessary components like printer or camera into an existing cartoning machine. This is usually done in cooperation with the supplier of the affected machine.
For the serialization of plastic bottles it is recommended to use labels. With the help of DIGILINE Label – Nearline serialized labels can be supplied directly to a labeling machine at high speeds and with superior printing quality. Moreover the printouts are extremely resistant against wear and abrasion.
In this case serialization data is provided by MEDTRACKER. The codes are inspected with vision systems that are typically installed in the downstream process and subsequently get stored back to the MEDTRACKER database.
As an alternative, labels can also be pre-serialized with the DIGILINE Label – Offline in order to centrally supply several packaging lines with one machine. Thanks to a high-performance camera system with integrated doctoring station maximum process safety is guaranteed.
Labels are also suitable for the identification of all primary and secondary packaging formats that are difficult to be coded or printed directly on in the packaging line.
Latest trends show that for smaller batches labels can also make sense to provide serialization data on folding cartons, especially if they are used at the same time as tamper-evident seals.
Besides serialization, in various countries aggregation is also required to ensure the traceability of pharmaceuticals among the logistics chain. During the packaging process, the codes applied to individual packs must be assigned to bundles, cases and pallets by way of hierarchies (parent child relationship).
For larger production quantities, the components required for this purpose – camera, label printer and applicator – can be integrated in automatic case packers.
When working with smaller batches and frequently changing jobs, a manual packing station like MEDILINE CodeCollectM is recommended. Thanks to high resolution camera codes, an entire layer is captured at once instead of scanning each single item with a hand held scanner. If required this procedure can be even repeated over several layers.
With the MEDTRACKER serialization software, every form of aggregation can be mapped and controlled in a process safe way. Thanks to the software architecture of MEDTRACKER it is possible to freely define the necessary workflows and to change the amount of aggregation hierarchies at any time if required. As every fully automatic aggregation process requires the possibility of manual rework in the case of rejects and since warehouse processes like commissioning and returns make it necessary to dissolve and recreate aggregation hierarchies, it is recommended to install a serialization database on site level (ISA95 Level3) that allows to centrally manage all created aggregation data.
Even though the aggregation of individual packs is not mandatory in some regions like the EU, it is a process that can generate significant value, typically for those seeking to optimize logistics, coordinate eventual callbacks or to blacklist stolen products.
Thanks to MEDTRACKER, the serialization and track & trace processes described on these pages can be controlled and monitored centrally across multiple lines and sites.
MEDTRACKER encompasses all the current and forthcoming regulations and principles governing coding and serialization. Thanks to its modular software architecture, new requirements can be incorporated subsequently at any time.
When you embark on the search for a suitable supplier, asking a few key questions can prove useful
Atlantic Zeiser can answer “yes” to all these questions. As a highly skilled supplier of serialization and track & trace systems, we offer you the best possible solution and perfect project implementation.