Inkjet & Digital Printing
Parallel importer of pharmaceuticals chooses Atlantic Zeiser
Friday 24. May 2019 - The implementation of the EU directive 201162EU, which is intended to put a stop to medication counterfeiting, is one of the most comprehensive infrastructure projects regarding the supply of pharmaceuticals.
As of February 9, 2019, every single packaging unit of prescription-only drugs that is put on the market in the EU is marked with a unique, individual serial number. In total, the European pharmaceutical industry has invested a three-digit million sum into technological requirements. Pharmaceutical companies had three years to prepare – a short deadline in view of the complexity of this task, and given the fact that other regions outside the EU were working on similar projects in order to obtain security from counterfeited drugs. In most cases, these non-European projects had or have different rules regarding infrastructure, track & trace, and data processing. But in all cases, the goal was to create an absolutely reliable, transparent, and audit-proof workflow for the serialization of pharmaceuticals – not only on one production line, but rather spanning multiple production sites or even countries. Very few technological partners are able to fulfill these requirements.
EU serialization regulations are a special challenge for so-called parallel imports or reimports of pharmaceutical products. Such pharmaceuticals must not only be serialized – their existing serialization must first be deregistered. “But we were well-prepared and able to implement the EU requirements in time”, says Mick Nøbbe Rasmussen, Project Manager Serialization at Abacus Medicine, a fast-growing parallel importer of pharmaceuticals. Headquartered in Copenhagen, the Danish company employs a complete serialization solution from Atlantic Zeiser. Comprising both software and hardware components, the Atlantic Zeiser solution was initially implemented at Abacus Medicine’s main production site at their logistics center in Hungary. As the solution quickly proved very efficient and practical, the company soon equipped two further production sites: one Abacus location in the Netherlands and one Contract Manufacturing Organization (CMO). Abacus is already planning the next extension to its main production site which will increase its capacities by 30 percent.
For all international regulations
The goal is always the versatile generation, importing, management, distribution, printing, and aggregation of codes for different international regulations. Important factors included data exchange on a company level across several locations, secure handling of filled and empty folding cartons, and the efficient processing of relatively small batch sizes. Abacus Medicine is among the market leaders in the field of especially expensive pharmaceuticals which are used e.g. for chemotherapies or in the course of organ transplants. Currently, the company holds more than 3,000 licenses for pharmaceutical products, with several hundred more being added each year. Buyers include pharmacies, wholesalers, and hospitals, who can thereby counteract the rising cost pressure for pharmaceuticals. “We exclusively distribute prescription-only original pharmaceutical products. Therefore, the obligation to serialize applies to our whole product range”, says Project Manager Mick Nøbbe Rasmussen. “Our workflow, however, is considerably more complex than processes at typical pharmaceutical manufacturers. And as we are dealing with a very wide range of packaging and batch sizes, we needed a solution which enables manual as well as semi- and fully automatic processes. Therefore, it was important for us to find a partner like Atlantic Zeiser who can not only contribute extensive know-how but is also very versatile while keeping to a tight schedule.”
High efficiency even for small batch sizes
Depending on the order size, Abacus Medicine uses two different solutions. Fully equipped with software, a printer, and a camera system for 100% verification, the MEDILINE T&T SI allows for the economic serialization of (very) small batch sizes and a wide range of formats in a small footprint. If required, the height of the printer and inspection camera can be adjusted, which makes the position of the code variable. With an optional barcode scanner and a label printer, the MEDILINE T&T SI even allows users to handle manual aggregation tasks. Abacus Medicine is already employing three of these track & trace modules in Hungary, and three more will be delivered shortly.
The DIGILINE Versa is employed for larger batch sizes. Compliant with all current serialization and coding requirements worldwide, it applies monochrome printing centrally, with a small footprint, to flat or glued cartons in a single pass ahead of the packaging process. The standalone system combines ease of use and integrated serialization software with pioneering and time-saving print technology. Two of these systems are already used by Abacus Medicine in the logistics center in Hungary.
“Experienced and thoughtful project management”
From the outset, Mick Nøbbe Rasmussen and his team were impressed by Atlantic Zeiser’s comprehensive expertise regarding both software and printing technology. Other points were important, too: “Compared with other companies that we looked into, Atlantic Zeiser stood out by quickly providing useful information and materials, through reliability regarding deadlines, and through experienced and thoughtful project management. Abacus has been very successful and achieved an average growth of more than 30% each year over the past five years. This means that our production processes are constantly evolving. What we needed was – and is – a partner that could help us design a serialization flow not for the company we are today, but for the company we imagine Abacus Medicine will be tomorrow. In Atlantic Zeiser, I believe we have found such a partner.”