Baking powder, sawdust or coloured water – such ingredients can repeatedly be found in counterfeit medicines. Beyond the health risks for patients, manufacturers and countries lose billions in revenue every year. At F. Hoffmann-La Roche AG, the OPAL Labelmanagement™ solution actively fights product piracy.
THE COMPANY
F. Hoffmann-La Roche AG: a global player from Basel
F. Hoffmann-La Roche AG is a globally active pharmaceutical company and a manufacturer of reagents and devices for medical diagnostics, headquartered in Basel. Founded in 1896, the company is the third-largest pharmaceutical company in the world, employs more than 94,000 people and generated revenue of CHF 50.6 billion in 2016. In the ranking of the 20 companies with the highest research and development spending worldwide, Roche stood in fifth place in 2015 – after Microsoft and ahead of Google.
THE CORE PROBLEM
Unit-level serialisation – required worldwide
Around the world, legislators require tamper-proof medicine packaging: Korea, Turkey, Brazil, the USA, China and the EU have all passed corresponding laws – Korea led the way on 1 July 2016, and the EU Falsified Medicines Directive (FMD) came into force in 2019.
The greatest challenge for pharmaceutical companies is the required unit-level serialisation: every individual sales unit receives a unique, randomised serial number of up to 20 digits, which is stored together with the product data in an official database. It is printed as a GS1 2D barcode that also contains the GTIN (Global Trade Item Number), the expiry date and the batch number. By scanning it with a mobile device, it is possible to verify at any point in the supply chain via the internet whether it is a legitimate sales unit – the authenticity appears immediately on the display.
Product label with a serialised GS1 barcode
THE SOLUTION
Central SAP Labelmanagement™ for all sites
For globally active pharmaceutical companies, serialisation is an extremely complex task in which various hardware and software systems have to communicate with one another. Roche decided early on to use a central solution for all of its production sites worldwide – and at the same time wanted to optimise and standardise the layout of its product labels. Not least for this reason, the AutoID system integrator OPAL Associates AG is among the suppliers of the overall solution.
“In the past, Roche had around 150 different label layouts that were managed in a decentralised way at our production sites in Switzerland, Germany, Brazil and the USA.”
Philipp Glockner, Responsible CoE Project Stream Leader, F. Hoffmann-La Roche AG
With the central SAP Labelmanagement™ from OPAL Associates AG, the number of layouts could be reduced by 90 percent – with no production downtime. To this end, the master data required for labelling the several thousand orderable products was first consolidated from various data sources. “My contacts at OPAL Associates AG proved extremely flexible and competent in doing so,” the IT expert praises.
SEAMLESS TRACEABILITY
S-TTS, BarTender® and Honeywell printers working together
At Roche, SAP Labelmanagement™ is addressed directly from the Secure Track & Trace System (S-TTS) by Laetus. As the leading system, S-TTS manages the serial numbers and uses cameras to monitor the correct printing of the packaging. OPAL Labelmanagement™ ensures correct labelling according to product- and country-specific requirements – optionally with characters in Arabic, Chinese, Cyrillic or any other script, which is indispensable for a global player.
Secure Track & Trace System (S-TTS) with OPAL LABELMANAGEMENT™ on the packaging line
Printing is handled by Honeywell PX4i high-performance printers: the all-metal devices produce up to 400 labels per minute at up to 300 millimetres per second, which an applicator then positions on the shipping units.
“The devices are very rugged and powerful, but above all very compact, so that we were able to integrate them perfectly into the cramped packaging lines.”
Philipp Glockner on the Honeywell PX4i printers
Illegible or incorrectly marked sales units are detected immediately by the cameras integrated in S-TTS; they are automatically sorted out and the associated serial number is marked as invalid in the database. The communication between S-TTS, OPAL Labelmanagement™, the machine control and the monitoring system was a novel challenge here: Roche has since equipped more than 40 packaging lines with S-TTS and OPAL Labelmanagement™, including the label-design software BarTender by Seagull Scientific.
IN LOGISTICS
OMS: a mobile solution for the entire supply chain
A lot can happen between production and consumer: full pallets are split, boxes are torn open, samples are taken, individual labels are damaged. For traceability at pack level, Roche needed a mobile solution that can communicate with S-TTS at any time. This is where the Mobile Solutions Framework (OMS) from OPAL Associates AG comes into play – an open platform for mobile AutoID applications that runs on all common mobile devices.
- →OMS works together with the TTW (Track & Trace Warehouse) system by Laetus and OPAL Labelmanagement™
- →Defective labels can also be reprinted and new labels generated in logistics
- →The easy-to-understand operator interface gives staff concrete action steps – results are reported and recorded in TTW immediately
- →In use on Honeywell CN70 and CK71 mobile devices – valued for their ease of use and fast scan engine
Honeywell CK71 mobile computer in logistics use
“Every change after leaving production can thus be meticulously documented and, where necessary, corrected.”
Philipp Glockner on OMS and TTW
CONCLUSION
Switched over early – for better patient protection
F. Hoffmann-La Roche AG switched its production and supply chain to the serialisation of medicines at an early stage, thereby making an important contribution to better patient protection.
Are you planning serialisation, track & trace or central label management in your production? OPAL brings the experience from projects like this one.
