Mandated serialisation standards across markets require pharmaceutical and medical device manufacturers to adopt specified standards to track and trace products across their supply chains. The newly updated serialisation solution from Rockwell Automation is helping these manufacturers and OEMs think beyond compliance and capitalise on major business benefits, such as long-term profitability, with a comprehensive, scalable, end-to-end supply-chain platform.

Built on the latest Rockwell Software PharmaSuite manufacturing execution system (MES) software, the new serialisation solution v4.1 is more scalable to adapt to a wide variety of packaging-line technologies and production-management systems. Easy integration across control and enterprise levels means the solution provides a centralised platform for managing serialisation data and facilitates product traceability across the entire supply chain.

A new Logix-based unit controller with FactoryTalk View HMIs from Rockwell Automation enables scalability, allowing the company to apply this solution to a variety of delivery models – from full, turnkey solutions to retrofit and OEM solutions – to meet the needs of virtually any customer. The unit controller acts as the connection point between each production line and various system devices. Beyond providing serialisation, the solution helps manufacturers improve troubleshooting and proactive maintenance by providing direct visibility into the full, end-to-end process – production through distribution.

“Many customers are struggling with how to best meet serialisation requirements or solutions that aren’t delivering as promised,” said Markus Rosenkranz, serialisation solution leader, Rockwell Automation. “Leveraging our portfolio, domain knowledge and global execution capabilities, we’ve designed our solution so it can be customised and easily integrated into each customer’s standard architecture and existing production processes.”

“This not only helps producers meet approaching deadlines for regulatory compliance, but means they will more quickly see the business benefits of the application and see a true return on investment. Our solution offers seamless interoperability among all machine devices, information and business systems, giving manufacturers the tools to increase yield, improve long-term profitability and easily adapt to future production or regulatory changes,” added Rosenkranz.

The updated serialisation solution includes a serialisation integration gateway with preconfigured channels for order creation and EPICS data exports to easily integrate into each customer’s system, greatly helping to reduce upfront engineering costs. The goal of Rockwell Automation is to build a comprehensive library of pre-engineered gateway channels to drive down costs and deployment of business systems integration. 

Additionally, the platform is equipped with a manual serialisation and aggregation workflow – a prevalidated, optimised tool for manufacturers with manual packaging lines. Approximately 90 percent of the potential serialisation customer base uses manual processes for handling unit aggregation and labeling. The Rockwell Automation serialisation solution provides an embedded label-design software for Windows driver printers and a user-friendly aggregation workflow to help these customers simplify their manual aggregation process, saving additional time and money.