Nearing the finishing line for pharmaceutical serialization

With a turnover of $21.9 billion in 2016, Teva is the global market leader in generic drugs. The pharmaceuticals giant operates in more than 100 countries and produces 16,000 different medicines to treat almost any medical condition. The firm’s Ulm and Blaubeuren sites together form a major production unit, employing some 1,300 people. 

February 9, 2019 marks the deadline to implement the EU directive protecting against falsified medicine in Europe. Medicines brought to the market by manufacturers must identify clearly defined safety characteristics on their packaging. The characteristics are then checked by the pharmacist before the medicine is given out, which helps to protect patients against falsified medicines.

To make sure all the requirements of legislation, including the Falsified Medicines Directive 2011/62/EU and Commission Delegated Regulation 2016/161 are met, Teva has invested in new packaging systems and is bringing its hardware and software on existing lines up to the latest standard. The product marking is printed using the REA JET coding and marking system, developed by REA Elektronik GmbH.

Around 320 million packages are manufactured every year at Europe’s largest pharmaceutical logistics center. A large proportion of that number comes from the sterile facility in Blaubeuren, where medicines are produced and packaged under aseptic conditions. A total of 44 packaging lines across the entire German production site are being upgraded to meet new legislative requirements.

The key criteria for the new machines included a high degree of flexibility and the ability to rapidly switch between formats, given the wide range of drug types produced and packaged at the site, such as tablets, ointments, liquids, sprays, syringes, and ampoules. The machines also needed to have compact dimensions and generate as little noise as possible.

Tailor-made solution

Before the project could be launched, a careful selection process was devised to evaluate the various tenders. The decision ultimately came down to a tailor-made serialization module, developed in partnership with Italian packaging machine manufacturer, Marchesini/Neri, camera and serialization software specialist, Antares Vision, and the leading German provider of industrial coding and marking technology, REA.

Teva has successfully used REA JET inkjet and laser coding and marking systems for folding boxes for several years on Marchesini lines, Uhlmann machines, including the first BLU 400, and OCS systems, amongst others.

Given the positive experiences gathered in-house with REA’s tried-and-tested and pioneering coding and marking system, the decision was easy, says Associated Director of Steriles Inspection / Labeling Packaging, Bernd Friesinger. The ever-reliable pre-sales and after-sales service provided by the coding and marking specialists with their expert knowledge on FAT, SAT, and IBN also won Teva over, Friesinger continued.

Total integration

The experts at REA JET and REA VERIFIER have extensive knowledge on local and global coding and marking quality requirements, a level of knowledge which goes far beyond the pharmaceutical serialization required.

REA’s product portfolio covers the full range of requirements for coding and marking, as well as verification of code quality in accordance with ISO/IEC/DPM, GS1 specifications, and securPharm. The necessary technical documentation – such as IQ, OQ, HDS, and SDS – was on hand and could be consulted to help draft SOPs. Technical and process safety capabilities were jointly assessed ahead of time and communicated while the project was being implemented through both internal, on-site training sessions, as well as at the REA training center at the company’s headquarters in Mühltal.

The various REA JET coding and marking systems deployed are all equipped with the latest open communication interfaces. Processes are executed in XML format, in line with the state of the art.

This makes the technical integration between the machine and the software solution very straightforward, ensuring consistently high printing performance. The coding and marking systems of the REA HR range, which can be fully integrated into existing systems, can therefore also be operated using the system’s current human-machine interface (HMI), for example. Whether used at the customer’s premises, directly on the device, or in a web-based process (i.e. at a manual workstation), the uniform user interface rounds off the simplicity of the coding and marking systems, making them a perfect model for Industry 4.0.

Integrated serialization

On each of the updated packaging lines, the assembled folding box comes out of the cartoning machine before being moved to a belt scale, which determines whether the total weight, including the instruction leaflet, lies within the prescribed limits. The package is then transferred to the serialization module, where it is coded and marked by the REA JET HR thermal inkjet printer and sealed with a tamper-evident cap. Country-specific information is printed on the package, including batch number, expiration date, bar code or Data Matrix code, serial number, and GTIN. This information is recorded in the master ERP system and sent to the REA JET inkjet printer by the serialization software. The printout and the code content are subsequently checked by a downstream camera using OCR/OCV to ensure that the details are legible and correct.

The resolution-optimized printing quality of the code is checked at random using the REA VeriCube optical verification device. Data storage and user management comply with 21 CFR Part 11 requirements, while a full audit trail and user management with multiple roles are also supported. Once marked and sealed, the folding boxes are then bundled and packed together in larger cardboard boxes.

Reliable processes 

Each system packs and marks up to 240 folding boxes every minute. The REA JET HR thermal inkjet printer plays a vital part in this: The high-resolution inkjet printer from the HR range uses HP printing technology which has been tried and tested millions of times. The robust stainless-steel housing of the controller and the clever print head design of this coding and marking system make it fully suited for use in industrial applications. Moreover, the HP cartridge technology requires no maintenance, guarantees high availability, and provides clean, contact-free printing on packaging. The wide range of different inks available from REA is ideal for use in the pharmaceutical industry; for example, the different certified inks based on water or solvents are suitable for a wide range of folding box materials and surfaces. As another intelligent feature, the high-resolution printing systems incorporate an additional safety check that verifies that the right ink is assigned to the right print job and the right material, as well as further functions that reduce the consumables used.

The flexible configuration and design options for fonts, bar codes, and Data Matrix codes are a key specification for a global company. Only the full support for Unicode and TrueType Fonts (TTF) provided by REA printing systems enable coding and marking requirements to be fulfilled for global markets.

Future-proof solution

Thanks to its innovative team of hardware and software developers, REA has been producing robust and pioneering industrial coding, marking and verification systems in Germany for more than 35 years, maintaining a network of satisfied customers across the globe. This is demonstrated by the Group’s ever-growing global presence, combined with the worldwide deployment of its systems – whether directly by the end customer or through OEM partnerships.

All requirements fulfilled

The team in Blaubeuren is ecstatic about the new state-of-the-art packaging lines, reports Bernd Friesinger, who spearheaded the project for sterile medication packaging. He adds: “The new future-proof facilities fulfill all of our requirements, as well as complying with the EU’s serialization Directive. With their ease of use and reliability, they are a winning solution.”

Asked whether he would recommend REA based on his experience, Friesinger didn’t hesitate: “Absolutely, every time.”

REA is pleased to be joined by Mr. Friesinger at its booth at the ACHEMA trade fair in Frankfurt am Main on June 11, 2018, between 2.30 and 4.00 pm (Booth C48, Hall 3.1). He will be happy to answer any questions you may have and share his experiences with you.

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