Arvato puts new machines into operation for the serialization of pharmaceutical packaging
Gütersloh/Harsewinkel – As part of a comprehensive serialization solution for its pharmaceutical customers, the Healthcare business unit at Arvato SCM Solutions has now put a new machine into operation to print and seal drug packaging.
To prevent counterfeit drugs from entering the legal supply chain, starting in February of 2019 every prescription medication in the European Union (EU) will have to bear a serialized data matrix code and be sealed. These unique identifying features will allow the medication to be traced and verified as original, as the relevant data will be filed in a central, EU-wide database. Serialization takes place through a complex interaction among different systems – a process that can only be managed using special machines, powerful IT systems and intelligent processes.
“The new system prints 2D data matrix codes on up to 30 boxes per minute and has been designed for sizes ranging from 15 grams to two kilograms”, explains Dr Caroline Strake, Head of Manufacturing Operations in the Healthcare business unit at Arvato SCM Solutions. “We are currently working on a different labelling solution specifically for products of unusual sizes or weights”. The quality of the printing and sealing, as well as the weight of each package, are monitored using an integrated scale, a camera system and a number of different sensors. “Code grading, i.e. the assessment of the quality and integrity of the data matrix code, is governed by relevant ISO standards and can be guaranteed by means of inspections during the production process and a separate verification device,” explains Jens Wagner, project manager responsible for the system at Arvato SCM Solutions.
The machine’s software can be connected to the Arvato Corporate Serialization Database CSDB, in short Arvato CSDB, so that serial numbers can be assigned correctly. The database is a full IT solution developed by Arvato Systems; it receives the serial numbers from the manufacturers or generates them on their behalf, and passes them on automatically to Arvato’s own production line along with the production order. Once the packaging has been printed and sealed, the serial numbers are either reported back to the customer or uploaded to the national verification systems on the customer’s behalf via the EU hub. With this service, Arvato SCM Solutions offers its customers the opportunity to serialize their products at short notice and without a high level of investment, thereby complying with the requirements of the Falsified Medicines Directive (FMD) within the EU as well as the growing global requirements relating to the protection of medicines against counterfeiting. Depending on the volume, the entire secondary packaging process can be taken care of, including serialization and aggregation.
Effects on logistics
The new directive will also result in far-reaching changes regarding the distribution of prescription drugs and the underlying processes. This is because even though the serial numbers on the medications are only read and verified when being dispensed to patients in the pharmacy, the data matrix codes must also be recorded at earlier stages in the supply chain in order to guarantee status management in the national verification systems. Here too, Arvato SCM Solutions offers its customers relevant logistics concepts that are geared towards satisfying the FMD serialization requirements, and in some instances even exceed them.
When developing new solutions, the Healthcare business unit can call upon the many years of experiences that other Arvato business units have with serialized products, as well as powerful IT systems and established processes. For example, in mid-February of this year, Arvato’s “light concept” went live at an international biotech manufacturer as part of a pilot project geared towards the requirements of the EU Falsified Medicines Directive and makes low-cost compliance with the FMD possible. A pilot project of the “full concept” for another customer is planned to start in the third quarter of this year. This will meet EU requirements as well as requirements for handling serialized pharmaceutical products that apply outside of Europe. “Through this concept, we are offering our customers a high-performance total package, which completely covers the process chain – from production to logistics to status management in the verification system,” explains Dr Thorsten Winkelmann, Managing Director of the Healthcare segment at Arvato SCM Solutions.