Case Study

Solid Dose Manufacturer Installs Serialization Efforts For Compliance

touchscreen terminal
Easy, intuitive operation via touchscreen terminal

Artesan Pharma Gmbh & Co. KG in Lüchow, Germany, demonstrates how an effective programme of serialization, i.e. the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.

Up to now, Artesan has made a name for itself mainly manufacturing solid dosage forms for specific orders, and other small to medium-sized batches of more demanding formulations. The company is now offering its clients innovative serialization solutions in accordance with the securPharm initiative. The Datamatrix Station XMV from METTLER TOLEDO PCE supports Artesan with Track & Trace and serialization tasks. "Innovation is the key to our success", explains Jorg Weinhold,Executive Assistant at Artesan. By implementing the securPharm concept, Artesan shows once again that it is a pioneer, this time when it comes to a modern serialization solution. securPharm is an initiative which prevents counterfeit medicines permeating German pharmaceutical sales. Each piece of medicinal product packaging is printed with a unique datamatrix code and an individual serial number. This pack number is then stored in a central database.

As such, each pack can be easily identified at any point in time. By doing so, Artesan can now offer a serialization solution to customers, which will become compulsory for all manufacturers from 2017 onwards. Jorg Weinhold goes on to comment, "We were on the lookout for an innovative partner, who was able to implement the requirements of the securPharm initiative". "Together with Pharmacontrol Electronic GmbH (METTLER TOLEDO PCE), we developed a reliable solution, which can be used to apply a unique datamatrix code to each product pack in line with securPharm requirements."

Thanks to the Datamatrix Station XMV, METTLER TOLEDO PCE provides a sound solution for reliable marking and verification of folding boxes for pharmaceutical products. Indeed, the most varied of tasks and specifications relating to serialization and Track & Trace can be fulfilled.

The compact Track & Trace solution XMV
At Artesan, the XMV is located on the production line between the cartoner and checkweigher. The Track & Trace solution marks packaging for purely prescription medicines, in line with the securPharm requirement, with a datamatrix code and a serial number in plain text. The individual pack number in the datamatrix code is stored in a central database and can be verified at a later date in the pharmacy, right before the sale. From now on, each and every pack of painkillers can always be clearly identified.

At Artesan, the XMV achieves a throughput of up to 350 packs per minute. The integrated camera checks whether the data content is correct and legible immediately after the printing process. Packs with incomplete print images or incorrect serial numbers are automatically ejected from the packaging line by an ejection device. Only units which are deemed to be suitable continue through the packaging process at Artesan.

The XMV stores the data acquired during the labelling and verification process in a database. This data is immediately available to Artesan for further processing in line with securPharm. The XMV not only fulfils the requirements of the securPharm initiative, but also other key identification and marking regulations in the pharmaceutical industry, such as ePedigree, Chinese coding, French coding, ITS (Turkey), IFA guidelines and European EFPIA marking. With the adjustable height and belt speed, the XMV can be easily integrated into every production line. For Artesan, the XMV was also equipped with caster feet. This means it can be deployed in a flexible manner to any of the 11 production lines.

"In METTLER TOLEDO PCE we have found a partner, who not only provide us with reliable products, but who has also met our individual requirements", concludes Jorg Weinhold.

Thanks to its comprehensive range of products and reliable services, METTLER TOLEDO PCE is the ideal partner for demanding pharmaceutical companies such as Artesan.