Software & Controls Systems for serialisation
Medicines Directive (FMD) takes effect in February of 2019; in the United States, enforcement of the Drug Supply Chain Security Act was pushed back one year to November 2018, from its original deadline of autumn 2017, but is still looming. That said, both markets are taking the steps for implementing what can be a complex process that touches several business areas for pharmaceutical manufacturers, packagers, and other vendors and suppliers. This is true for companies looking to adopt systems that offer value beyond baseline regulatory compliance. Considering what remains a muddied landscape, desired systems will likely trend toward more flexible, hardware-agnostic serialisation solutions that can adapt or scale up to meet future track and trace mandates, as well as improve business practices. Comprehensive systems, such as Adents
I
Prodigi, incorporate tools that utilise — for the sake of production improvements and personnel allocation — the troves of data that are required
n the pharmaceutical industry, deadlines for unit level serialisation are approaching on both sides of the Atlantic. In Europe, the EU Falsified
to be tracked and stored for reporting purposes by serialisation mandates. It is essentially turning a requirement, namely serialisation mandate compliance, into ROI-generating infrastructure. The Adents serialisation and aggregation suite of
software enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimising impact on production processes and productivity. As a standardised approach, Adents solutions are flexible, scalable, and quick to deploy because complete configuration takes place at the site level, making per-line configuration unnecessary. Adents serialisation software is hardware agnostic, meaning it is compatible with a wide range of equipment. Adents serialisation solutions, including Adents
Prodigi, bring an additional higher-level perk: Compliance with Europe’s fledgling medicines verification system. As part of the EU Falsified Medicines Directive (FMD), the European Medicines Verification System (EMVS) is a pan-European system designed so that medicines can be verified at the point of dispensing. As of February 9, 2019
marketing authorisation holders (i.e. brand owners and representatives) that commercialise drug products distributed in the FMD’s jurisdiction will be required to upload their product serialisation data on the European Hub, a process that will entail generating and managing serialisation data compliant with each target market. Adents successfully passed the EMVS
certification process, which comprises a series of thorough tests, thus becoming an official OBP (On-Boarding Partner) Gateway Provider. An OBP is a contracting party of the European Medicine Verification Organisation. Moving forward, Adents is authorised to sign on behalf of marketing authorisation holders and transfer unique identifiers and related information to the European Hub. In essence, Adents can now legally vouch for its customers concerning serialisation compliance.
www.adents.com
Complete solution for production efficiency O
mron’s products include a Quattro robot for pick-and-place applications, two mobile robots (LD60s), a high-speed
vision system, and a Sysmac Machine Controller. All of them are connected via The Cloud to deliver a complete, integrated, smart solution. This solution is just one example of Omron's ‘i-Automation’ concept, which aims to provide customers with intelligent, integrated and interactive solutions that support Industry 4.0 by enhancing the digitalisation of manufacturing. The system is completely linked, meaning that the data collected can be analysed to help overall system control. A key part of the Industry 4.0 future, smart data, allows a system’s production rates to be tailored to meet actual demand, shifting from the traditional ‘push-production’ approach of many industries to one of ‘pull- production’. Smart data also means problems can be detected, analysed and located in a timely fashion, allowing operators to determine the best maintenance schedule and minimising downtime. The Quattro robot is a four-axis parallel robot that achieves high speed and precision for pick- and-place applications. Combined with the vision system, it enables highly accurate pick-and-place
24 November 2017
control to deliver high-speed action, even when moving delicate objects. In addition to speeding production and reducing energy usage, the vision system also contributes to food insurance as it can quickly identify damaged goods, wrong or missing information on labels, or production issues. This allows only the affected batches to be pulled without having to perform expensive recalls. The mobile robots help improve health and safety for human operators by transporting heavy loads between stations. The complete system is controlled by a Sysmac control system, which manages processes and secure communication via The Cloud. “Our latest system solution aims to answer the challenges faced by today’s food and beverage industry,” says Stéphane Chômienne, general manager, Omron. “It gives more flexibility to deal with increasing SKU numbers, and better data collection and reporting. The automation also helps retain labour while dealing with the skills gap. Together with lowering costs, it promotes low maintenance and ensures maximum uptime. Furthermore, customers’ brands are protected through the quality production standards.”
www.omron.com
www.convertermag.co.uk
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