Customer Story: How Bionorica Meets Serialization Requirements

The preparations from the German pharmaceutical manufacturer have always combined the proven healing power of medicinal plants with the latest scientific discoveries. With the help of the phytoneering principle, Bionorica unlocks the great active ingredient potential of nature by using state-of-the-art research and innovative technologies. The result is effective and safe herbal medicines for respiratory and urinary tract diseases, liver problems or in the field of gynecology. 

At the company headquarters in Germany, Bionorica has been relying on Wipotec systems for a long time. Every day, thousands of tablets and coated tablets are produced and prepared for shipment. Other popular products are liquids like syrup or drops –  both available in the typical folding boxes. Brands such as the combination preparations Sinupret and Bronchipret are used by countless patients nationally and internationally. Ensuring that medicines are always safe and reliable can only be achieved in compliance with all country-specific regulations. Serialization in the pharmaceutical industry ultimately protects health. 

Bionorica takes its social responsibility as an employer and pharmaceutical manufacturer very seriously. With a com-prehensive compliance culture, the medium-sized company is committed to following internal and external rules at all times. The fact that these regulations vary from country to country and are constantly being revised makes this assignment quite a chal-lenge. Bionorica has to label its products differently depending on the sales market and therefore needs systems that offer this flexibility. Also, when regulations evolve, Bionorica must be able to adapt.

In the course of this kind of development, the Track & Trace solu-tions from Wipotec were given an upgrade to enable country- specific coding. These TQS units are designed to ensure that even machines that are already installed can be easily adjusted to new standards. If, for example, countries introduce the serial-ization of over-the-counter medicines, Bionorica is well prepared thanks to its partnership with Wipotec. From the very beginning, during the implementation of the checkweighers and their initial selection, Bionorica quickly recognized the benefits of Wipotec’s expertise, which was confirmed by the addition of the TQS solutions.
In cooperation with the Wipotec technicians, Bionorica has always found a solution to every problem – especially in times of intensive consultation. “I personally have been particularly im-pressed by the reliable support at every step,” continues Mike Hofmann (Head of Packaging at Bionorica). “If one of the inev-itable disruptions occurred in the beginning, I simply called the responsible technician on direct dial. We could always count on Wipotec, especially when there were bottlenecks. I have experi-enced this very differently before.” Even complex issues were re-solved immediately via remote support. Today, Bionorica is fully in control of the processes. 

“If someone  asked me today if I had any experience  with Wipotec, the answer would be yes – very, very good ones.”

Mike Hofmann – Head of Packaging at Bionoroca SE

The employees at the company headquarters in Neumarkt cur-rently operate four lines with Wipotec equipment. One of the highlights is the TQS-HC-A-TE marking system, which runs at a high speed of 400 pieces per minute. The system performs inline labeling and serialization of folding boxes in a variety of sizes and immediately verifies the imprint. The TE unit for protection against tampering is still waiting to be used at Bionorica, although various test runs have been successful. Besides the standalone TQS units, also the case packers and palletizers where equipped with integrated modules (OEM) which enable fully automatic aggregation. These spacesaving devices are installed and operational in just a few weeks.
While the TQS-HC-A-TE system is responsible for the packaging of the solids, Bionorica also uses the TQS-SP-TE serialization solution for the liquids. The liquid dosage forms such as  syrups or drops are provided with the corresponding  serialization code in their folding cartons on a minimal footprint. High-resolution cameras immediately check the print quality in accordance with ISO 15415 in the process. From Bionorica’s experience, how ever, the workflows of the machines differ only slightly. The main difference lies only in the fact that the liquid lines have two discharge tunnels, while the solid lines only need one. They only encounter challenges when fundamental changes need to be made – as in the initial approach to serialization. Not only the hardware and software have to adapt, but also the operators.

“The Wipotec systems especially impress with their outstanding user interface: a playful design, colorful and yet clearly arranged.”

Uwe Raschel – Shift Manager Assembling and Key User Computer Systems at Bionoroca SE

At Bionorica, an internal project team carried out the major part of the preparatory work through to the implementation of the new systems. The subject of serialization, for example, requires a precise comprehension of the legal texts and the relevant regulations so that the language barrier does not represent an obstacle. Another project team was then dedicated to the technical implementation. Wipotec was selected quickly because of the excellent cooperation achieved with the dynamic weighing solutions. Uwe Raschel, the shift manager of a production team, reports: “There are no complaints about the functionality of the machines. The technology works just as it should and any bugs never take long to fix.” This user-friendliness is what sets Wipotec apart. Processes can be controlled effortlessly via the central HMI, which means that not every component has to be operated and set up individually when changing formats.

The employees at Bionorica can carry out the set-up process in just a few minutes. As the folding cartons are generally quite similar in size, only the system's camera and printer need to be positioned. At the beginning, the Wipotec support helped to create article templates so that only a few variable data were missing. The relevant options were already presented to the project management and operators during a demo in the Track & Trace showroom in Kaiserslautern. According to the team, the comprehensive simulations with the virtual machine also helped enormously in developing an understanding of the new interface. At first, there were some reservations among the staff regarding the transformation itself, but no genuine concerns arose. This was thanks to their familiarity with the identical user interface of the checkweighers.

“The downtimes of our systems are very low. I can recommend Wipotec in all good conscience.”

Manuel Ritter – Leader Packaging Technology at Bionoroca SE

Nowadays, contact with Wipotec’s service staff has become rare. While serialization was still considered unknown ground at the time of installation, the operators are gradually becoming experts. “We are making very good progress,” says Manuel Ritter, leader of packaging technology. “The figures from our production data acquisition system show that everyone involved is coping better and better with the changeover.” It was a great advantage that Bionorica involved its entire team in the key processes right from the start – at all sites. The pharmaceutical company is therefore excellently equipped for the future. Wipotec is happy to provide support for all further projects and is proud of the successful cooperation.