Medical device manufacturers that combine discrete and batch processes in their operations can now use the PharmaSuite manufacturing execution system (MES) software from Rockwell Automation as their sole track-and-trace platform, achieving tracking capabilities down to the smallest saleable unit.
The PharmaSuite v7.0 software extends its batch track-and-trace capabilities, already used by some of the world’s largest pharmaceutical producers, into the discrete environment. This provides hybrid capabilities for the growing market of combination products that require both batch and discrete-assembly processes, such as medical devices that are combined or coated with a pharmaceutical ingredient during production.
'Discrete and batch processes have historically required separate track-and-trace systems, but PharmaSuite v7.0 software reduces the need for disparate systems,' said Martin Dittmer, PharmaSuite Product Manager, Rockwell Automation.
To help make high-throughput production operations more efficient, the PharmaSuite v7.0 release includes streamlined usability patterns at the workstation level. This allows assemblers to quickly identify the correct components and view assembly instructions with the scan of a bar code. The software also includes order-management and electronic device history record (eDHR) support to ensure the assembly process for every medical device is tracked and documented. Rework and repair capabilities also help streamline tasks for any devices requiring such work.
New dashboard filter capabilities allow end users to filter product criteria by 20 different attributes, including exceptions, orders and batches, to customise the dashboard to their specific roles. Quality-assurance personnel, for example, can use the filter to instantly sort through thousands of devices and view only those with exceptions. Once created, the customised filters can be saved and stored for future use.
PharmaSuite also powers Rockwell's holistic serialisation solution, which helps pharmaceutical manufacturers comply with pending track & trace regulations. This allows serialisation to be fully integrated across all four enterprise and control system levels of the ISA-95 data model.
The solution leverages the Microsoft Azure Cloud-computing platform and services, and seamlessly connects and shares data between the plant floor, the enterprise, supply-chain partners and the retail point of sale – and potentially, right to the customer. The common serialisation data thread, which provides real-time visibility to a company’s products and customers, can increase the efficiency and productivity of all departments in The Connected Enterprise, from manufacturing, quality and finance to supply chain, logistics and marketing.
'Life science companies must implement or upgrade track-and-trace systems to meet the growing number of serialisation regulations worldwide,' said Joe Whyte, Global Serialisation Lead for Rockwell Automation. 'Our serialisation solution offers manufacturers compliance, but also helps them to achieve real commercial and business benefits. The offering can help manufacturers avoid millions in inaccurate chargeback or rebate payments. The system can reduce the cost and improve the accuracy of product recalls. Production rates that are driven by real-time consumption data can lead to optimised manufacturing and supply-chain inventories.'
The solution is designed for interoperability across every level, including integrating with different controllers, networks and serialisation devices on the production line, as well as with MES and ERP systems at the site and enterprise levels.
As a standard solution, the system integrates into existing production lines to help minimise production interruptions and validation burdens. Additionally, Rockwell Automation offers remote-support capabilities, including real-time diagnostics monitoring and application-level support, to help minimise potential downtime.
The holistic serialization solution uses a GS1 Electronic Product Code Information Services (EPCIS)-certified platform from Covectra of Westborough, Massachusetts. The EPCIS-certified platform provides global serial-number generation and supply-chain event repository data management with applications that include downstream track and trace, consumer authentication, patient adherence and patient outcome monitoring.
