The medium-sized pharmaceutical company mibe GmbH has been based in Brehna in the greater Leipzig-Halle area since 2003. With nearly 500 employees, mibe is the centre of development, production and logistics of the Dermapharm group, which markets its products (brand generics) in Central and Eastern Europe. The company produces a remarkable variety of pharmaceuticals, including tablets, ointments, drops, sprays, syringes and vials. The plant is equipped with state-of-the-art, flexible production facilities. In total, they produce about 35 million pharmaceutical packages per year, of which most are prescription drugs. The company deliberately chose Germany as location. Now, in implementing the EU Delegated Regulation 2016/161 (based on the directive 2011/62/EU), they are again counting on "Made in Germany" and track-and-trace systems from R. Deckert equipped with REA JET coding and marking technology.
mibe produces pharmaceuticals for the national and international market on an area of 40,000 square meters.
Starting in February 2019, prescription drugs may only be put on the German market if their packaging is labelled individually with a unique serial number and is clearly undamaged. A challenge for the entire pharmaceutical industry.
This is why mibe promptly began selecting a suitable system supplier. Together with the Schwäbisch Hall based company R. Deckert, which specializes in packaging and filling systems for the pharmaceutical industry, they initiated a project for a track-and-trace system fulfilling packaging specifications for a variety of different dosage forms. R. Deckert presented a convincing concept and introduced a modular system for integration into the packaging line including an automatic format change. This is of extreme importance considering the large number of different dosage forms and packaging.
The expert team makes the difference
An entire team was deployed to equip the track-and-trace station, as R. Deckert takes great care in selecting suitable system partner: In the area of coding, the industry experts from Jan Hessing print & control scored with their competent consulting and an attractive comprehensive package, consisting of REA JET marking technology and REA VERIFIER code verification devices. As successful REA JET distribution partners, they also supported the test phase and integration of the high-resolution printers from the series REA JET HR pro. "With inkjet printers a clean and simple handling is of fundamental importance. REA JET has proven great competence in this area with easy ink cartridge handling and a modern controller that can process all data sets smoothly", R. Deckert project engineer Ömer Razgatlioglu confirms the advantages of the technology. With a camera system from scanware electronic GmbH and a labeler from Herma, the expert team was completed and the optimal serialisation and track-and-trace solution was found.
From the right: Detlev Schermer (Sales scanware), Andreas Gruber (Head of Electrical Engineering R. Deckert), Martina Wagner (Marketing scanware), Ömer Razgatlioglu (Project Engineer R. Deckert), Jan Hessing (Jan Hessing print & control), Andreas Bauer (Head of Production mibe GmbH), Reto Heil (Marketing REA JET).
At the beginning of 2016, the first track-and-trace system for mibe was integrated into a packaging line for solid dosage forms. After a successfully completed testing phase it finally went live. Since then, the products now also pass through the track-and-trace station following the cartoner. The filled folding boxes are first individually clocked into compartments on a conveyor belt by means of mechanical fingers. Within this process they are entered into an electronic shift register and are uniquely recorded for further processing. This is followed by the high-resolution marking of the folding boxes with a thermal inkjet printer from the series REA JET HR pro. Information such as the Data Matrix code, serial number, PPN, batch designation and expiry date (unique identifier as per delegated regulation 2016/161) are printed on the folding box. After that, the correct marking is inspected with a scanware camera. Misread packages are sorted out. Finally, the side flaps of each box are sealed with labels to document its originality and integrity of the packaging.
R. Deckert track-and-trace system with a REA JET printer and scanware camera system.
The order papers are scanned with each new production batch. Thus, data for the automatic format change of the production plant can be taken directly from the mibe ERP system (Enterprise Resource Planning). A motor powered actuator regulates the adjustment of the guide rails so that no "changeover time" is required. The consistent and secure transport of the folding boxes via conveyor belt supports the positioning accuracy and the precise marking of the package. Print data from the ERP system is transmitted via the scanware camera system control unit to the REA JET controller. Data is processed in real time and to the assigned print heads. A light barrier controls and triggers the starting point of the printing, the camera shot, the ejection and the length measurement of the folding box.
REA JET marking system with scanware camera control system.
Universal print technology
Up to 75,000 folding boxes are serialised at the packaging line per day. Therefore a high-performance coding and marking system is especially important. According to Andreas Bauer, Head of Production, the thermal inkjet printer integrated in the track-and-trace system, REA JET HR pro, stands out with its high availability, very good print quality and easy operation. The system can be used universally and guarantees high-resolution coding and marking of both absorbent and non-absorbent surfaces. Thanks to the proven HP cartridge technology, the printing system is maintenance-free and operates without wearing parts at consistently high precision.
Being a central component of a track-and-track system, the REA JET HR pro allows for a high-speed continuous serialisation. Information is directly processed and printed. Since print data is automatically obtained from the mibe ERP system, there is no need for manual input. Moreover, transcription errors are prevented. The support of Unicode and TrueType fonts (TTF) allows coding according to the corporate design. The high resolution in combination with enormous reproducibility guarantees a remarkable and ever constant print layout.
Pharmaceutical packaging with Data Matrix code and tamper-evident glue flap.
REA JET printing systems offer flexible configuration and design options for font types and graphic integration. The REA JET HR systems support TrueType fonts as well as the complete Unicode character set and use UTF 8 as coding for data exchange. In this way, almost any globally used font type can be printed. Moreover, corresponding data can be processed by the machine control or by external ERP systems. The quality of the machine-readable codes consistently meets the strict requirements of the pharmaceutical industry. Today’s global coding and marking regulations are taken into account and future regulations can be adapted easily. To verify the quality of the printed 1D and 2D codes, mibe relies on code verification systems from REA VERIFIER. For ensuring the required high code quality, they are using the state-of-the-art REA VeriCube System.
The Hessian company REA is a specialist in industrial coding and marking technology. Its portfolio comprehends inkjet printers, laser, spray mark and labeling systems that have proven for over thirty years across all sectors worldwide. REA JET coding and marking sytems are fully integrable and can be operated directly or via the machine control of the plant (HMI). The data structure and communication interface are conducted in XML and are thus based on an open IT standard. The consistent use of XML for equipment control permits full integration into the user interface of the entire plant (HMI). All that makes REA JET coding and marking systems ideal for machine and system manufacturers.
The REA JET HR pro controller has been fully integrated into the R. Deckert track-and-trace system.
In future, the Dermapharm group will build on its German location. Thus, pharmacies, hospitals and pharmaceutical wholesalers can be supplied at short notice with currently more than 1,500 products – a significant benefit in international competition. Modern infrastructure, highly qualified employees and engineering expertise also contributed to the success of the current project: The first track-and-trace system has performed outstandingly. Another ten further track and trace systems including REA JET coding and marking technology and scanware cameras have been ordered from R. Deckert to bring further packaging lines up to date. Thanks to the state-of-the-art track and trace system, mibe already today meets the legal requirements for the counterfeit protection of pharmaceutical products.
About the company
REA JET develops and manufactures premium industrial coding and marking systems for contact-free industrial marking. The portfolio includes ink jet printers, laser and spray mark systems, labeling solutions, as well as inks and consumables. The practically orientated products are designed for use in all branches and have proven worldwide across all industries and business segments.
REA JET and REA VERIFIER (Code Verification Systems) are both divisions of REA Elektronik GmbH based in Muehltal, near Frankfurt am Main. REA Card, another REA division, develops and markets cashless payment systems. REA Elektronik was founded in 1982, is owner-operated and employs a staff of over 300 (2015). All REA JET products are 100 percent made in Germany.
REA Elektronik GmbH
T: +49 (0)6154 / 638 0