Final spurt towards pharmaceutical serialization

The implementation of the protection system for medicinal products in Europe came into force on February 9, 2019. Pharmaceutical packaging that is placed on the market by the manufacturer has to have precisely defined safety features. These features are verified by pharmacies before the medicines are dispensed in order to protect patients from counterfeit medicines.

In order to meet all requirements, including the Falsified Medicines Directive 2011/62/EU and the Delegated Regulation (EU) No. 2016/161, Teva has purchased new packaging lines and upgraded and updated existing lines in terms of both hardware and software. The respective product markings are printed using REA JET coding and marking systems from REA Elektronik GmbH.

The largest logistics center in the pharmaceutical industry in Europe handles around 320 million packages a year. A significant proportion comes from the sterile production area in Blaubeuren/Weiler, where medicines are produced under aseptic conditions and then packaged. A total of 44 packaging lines were retrofitted at the entire German production site in order to comply with legal requirements.

Important criteria for the new machines were a high degree of flexibility and the possibility of fast format changeovers, as many different forms of medicine such as tablets, ointments, juices, syringes, syringes and ampoules are produced and packaged on site. The machines also had to have compact dimensions and be as quiet as possible.

Tailor-made solution

To implement the project, various solution providers were evaluated in advance in a careful selection process. In the end, the decision was made in favour of tailor-made serialization modules in cooperation with the Italian machine manufacturer Marchesini/Neri, the camera and serialization software specialist Antares Vision and the leading German supplier of industrial coding and marking technology, REA.

REA JET ink cartridge and laser coding and marking systems have been used successfully at Teva for folding carton coding on Marchesini lines, Uhlmann machines, including the first BLU 400, and on OCS systems.

Bernd Friesinger, Associated Director Sterile Inspection/Labeling Packaging, reports that the company's positive experience with REA's proven and future-oriented coding and marking technologies made the decision easy. Last but not least, the consistently reliable pre- and after-sales service of the marking experts (e.g. for FAT, SAT, IBN) was convincing, says Bernd Friesinger.

Complete integration

The experts at REA JET and REA VERIFIER have extensive knowledge of global and local marking and code quality requirements, far beyond the environment of required pharmaceutical serialization.

The REA product portfolio fully covers the requirements for marking and Code quality verification (ISO/IEC/DPM, GS1 specifications, securPharm). The necessary technical documentation (IQ, OQ, HDS, SDS etc.) was available and could be consulted for the creation of SOPs if required. Technical and process-reliable feasibilities were jointly verified in advance and communicated during the project implementation in in-house training courses and training sessions on site, as well as at the REA training center at the company headquarters in Mühltal.

The various REA Coding and Marking Systems used all have modern, necessarily open communication interfaces. These are designed in XML data format and therefore comply with the IT standard.

This makes technical integration very easy for machine manufacturers and solution providers, which in turn ensures very high and consistent printing performance. The fully integrated REA coding and marking system of the HR series can therefore also be operated via the existing machine control of the machine (HMI), for example. The uniform user interface, whether used by the customer, directly on the device or web-based, for example at a manual workstation, rounds off the simple handling of the Industry 4.0-compatible coding and marking systems in an exemplary manner.

Continuous serialization

In each of the updated packaging lines, the loaded folding carton comes out of the cartoning machine and first runs over a belt weigher, which uses weight determination to check whether the folding carton is within the weight tolerance range up to the package insert. The packaging is then fed into the serialization module, where it is marked with the REA JET HR thermal inkjet printer and sealed with a tamper-evident seal. Country-specific data and information such as batch number, expiry date, barcode or Data Matrix code, serial number and GTIN are printed. This data is generated in the higher-level merchandise management system and transmitted to the REA JET inkjet printer by the serialization software. The imprint and the code content are verified by a downstream camera for readability and correctness of content (OCR/OCV).

The achieved, always resolution-optimized print quality of the codes is randomly verified using the REA VeriCube optical verification system. Data storage and user administration are carried out in accordance with 21 CFR Part 11 specifications. A full audit trail and user management with multiple roles are supported. The labeled and sealed folding boxes are then bundled and packed in cardboard boxes.

Process-reliable sequences

Each of the machines packs and marks up to 240 folding boxes per minute. The REA JET HR thermal inkjet printer is a key component that makes this possible. The high-resolution inkjet printers in the HR family make use of HP printing technology, which has proven itself millions of times over. The robust stainless steel housing of the controller and the sophisticated print head design make these coding and marking systems suitable for industrial use without restrictions. The maintenance-free HP cartridge technology guarantees high availability and contact-free, clean marking of packaging. The wide range of different inks from REA is ideal for use in the pharmaceutical industry. Different certified inks containing water or solvents are used for different folding carton materials and surfaces. Intelligent system functions of the high resolution printing systems enable an additional safety query of the ink assigned to the print job and the material, as well as additional functions that reduce consumables.

The flexible configuration and design options for fonts, barcodes and Data Matrix codes are an important requirement for internationally operating companies. Only the full support of Unicode and True Type Fonts (TTF) of the REA printing systems makes it possible to meet the coding requirements of global markets.

Future-proof solution

With its innovative hardware and software development team, REA has been developing robust and future-oriented marking and code verification systems for the industry for over 35 years, producing them in Germany and maintaining satisfied customer relationships worldwide. This is confirmed by the ever-growing global presence of the group of companies, combined with the worldwide use of the systems offered, whether directly by the end customer or through OEM cooperations.

All requirements fulfilled

Bernd Friesinger, who managed the project for the packaging of sterile dosage forms, reports that the company in Blaubeuren is highly satisfied with the modern packaging lines and adds: "The new machines meet all our requirements, including those of the EU directive on serialization, are future-proof and also impress with their convenient handling and productive reliability".

When Mr. Friesinger was finally asked whether he would recommend REA on the basis of his experience, he promptly replied: "Of course, anytime".

Mr. Friesinger will be a guest at the REA booth in Hall 3.1, Stand C48 at the ACHEMA trade show in Frankfurt am Main on 11.06.2018 between 14:30 and 16:00. He will be available to answer questions from interested visitors and is looking forward to a lively exchange of experiences.