Mettler-Toledo is a leading global manufacturer of precision instruments and services, for use in laboratories and manufacturing. Reinhold van Ackeren, head of marketing and product management, discusses how the company’s suite of software helps guarantee compliance in the complex world of track and trace.
Why are software systems for track-and-trace processes in the pharmaceutical industry so important, and what does Mettler-Toledo offer?
Reinhold van Ackeren: Any pharmaceutical company that wants to ensure its operations are fit for the future needs to bear track-and-trace processes in mind. In an increasing number of markets, only those who meet the required standards for serialisation and traceability are finding themselves eligible to do business.
Mettler-Toledo provides a software suite that networks printing systems on production lines with the central ERP, MAS or cloud system, facilitating efficient track-and-trace processes. The system represents a best-practice scenario for managers and production directors, delivering a seamless, automated flow of data from higher corporate software systems directly to the production line and back.
How does the Mettler-Toledo software suite work?
From job preparation and serial number handling to reporting, all the tasks can be carried out from a production site’s central location or office, in order to save valuable time on the production line. Bridging the gap between the ERP system and the production line – in other words, performing serialisation and aggregation tasks – is essential when it comes to implementing international track-and-trace guidelines. Particularly in cases where manufacturers are required to create reports on serial numbers in use and send them on to various institutions, an ERP link is crucial.
Each production line in a pharmaceutical manufacturing facility is controlled by separate production-line software that interfaces with hardware components such as marking and camera verification systems.
What makes this the right software package for single-serialisation stations and for the management of multiple parallel lines?
PCE Line Manager (PLM) manages all activity within one production line, from a single marking unit to a complex serialisation and aggregation line with multiple stations. The higher-level site-management software, PCE Site Manager (PSM), bundles the information from the individual production lines, as well as establishing a link to the ERP or cloud system.
Beyond level-one integration (the control of hardware components) and level-two integration (management of multiple machines in a production line), there is also level-three integration across the lines. PSM runs on an application server and is constantly available within the company network. Users with the appropriate rights can gain access to the user interface from any workstation connected to the internet within the company.
The combination of PLM and PSM is the right choice for pharmaceutical manufacturers with multiple lines at a site. It also enables the full track-and-trace process, from item-level serialisation to pallet aggregation, if required. Interfaces to higher-level ERP or cloud systems can be customised to meet customer expectations.
What kinds of issues do your clients approach you with?
Many customers have less complex requirements than all this: they just want to make sure they comply with serialisation requirements; for example, fulfilling the latest European requirements for carton serialisation, or the latest US requirements for carton and case serialisation.
And what if there’s no need for aggregation?
For full line management or synchronisation of multiple parallel lines by means of site management software, the new software package, PLM direct, is the way to go. PLM direct can be integrated by customers based on the interface description. If required, we can also provide end-to-end service, to integrate the software into the ERP system or connect it to a cloud system.
Not only is PLM direct a software package that can easily and quickly be integrated, but the package also includes the Factory Acceptance Test (FAT) and initial set-up of Mettler-Toledo serialisation stations at the customer’s site. The serialisation station is preconfigured to fulfil various coding scenarios, whether GS1 or non-GS1 coding. With this software and service package, PLM direct secures minimum downtime in production.
