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Serialization systems can share information between manufacturing and business units, supply-chain partners, and the retail point of sale.
Serialization has been a hot topic at INTERPHEX 2015. The US Drug Supply Chain Security Act (DSCSA) has come into effect and will be implemented in stages over several years, with a deadline of 2023 for unit-level tracking. Many aspects of serialization, including the printing equipment needed to print barcodes and vision systems to inspect them, have been discussed in presentations and seen on the show floor. Another crucial aspect of implementing a serialization system is collecting and handling data. An ePedigree (i.e., track-and-trace) system can be part of a shared information system to drive efficiency and quality, say experts from Rockwell Automation, who will be presenting "Serialization-Overcoming Challenges to Achieve Compliance + ROI" on Thursday, April 23, at the Rockwell Automation Center for The Connected Enterprise, located at booth #CP-3. Pharmaceutical Technology spoke with Joe Whyte, global serialization lead at Rockwell Automation, about the data layers in an ePedigree system and what companies need to consider as they implement a full track-and-trace system.
Data layers in an ePedigree system PharmTech: How do you define the data layers of an ePedigree system?
Whyte: Serialization-relevant data is widely distributed over control and information systems across many levels or layers. Rockwell Automation identifies these layers based on the enterprise and control system levels of the ISA-95 data model. Serialization levels are defined as:
PharmTech: Can these five layers be implemented separately?
Whyte: An effective serialization solution requires data from across layers. Data must be connected and shared from the plant floor to the enterprise, supply-chain partners, and the retail point of sale. The layers can be implemented separately, but a holistic approach must be taken in implementing all layers to ensure interoperability. Using standards such as GS1 for the supply chain and EtherNet/ IP for the plant floor, coupled with commercial off-the-shelf programmable-logic controllers (PLCs) for data connectivity and data management with packaging machines, printers, and vision systems can achieve interoperability. The common serialization data thread, which provides real-time visibility to a company’s products and customers, can then be used to increase the efficiency and productivity of all departments in an enterprise, including manufacturing, quality, finance, supply chain, logistics, and marketing.
PharmTech: How can the layers be connected?
Whyte: Many existing 'black-box' serialization solutions were custom developed and created at the machine or enterprise levels. These systems often result in integration challenges with batch-, processing-, or plant-level systems, and can be difficult to maintain long term. Pharmaceutical manufacturers should consider basing their system on a modular and scalable off-the-shelf control and information platform that can be easily integrated into their existing lines. Specifically, by tapping a software platform that also offers MES and electronic batch recording (EBR) capabilities, a serialization system can help address global serialization requirements, including necessary data capabilities and high-speed device management of serialization components-all while minimizing production interruptions or validation burdens.
Planning for DSCSA deadlinesPharmTech: What do companies need to consider now, when installing equipment and systems, to plan ahead for future compliance with final DSCSA 2023 deadlines for item-level electronic tracking?
Whyte: The system must be able to handle a large volume of data management to meet unique identification (UID) printing and verification demands in high-speed environments. Data must also be secure, yet seamlessly integrated across multiple levels, from packaging and palletizing machines on the plant floor to MES and ERP systems and a cloud-based event repository. It’s also important, however, not to forget the silver lining of a comprehensive and holistic serialization system. Greater supply-chain integrity offers more than compliance. It can also deliver reverse-logistics benefits and more accurate and efficient recalls, and it can provide valuable data for improved forecasting and more customer-specific marketing programs. So as you begin implementing serialization systems, don’t only focus on what the system must do. Start thinking about what the system can do.
Cloud-based systemsPharmTech: How does the use of cloud-based track and trace facilitate serialization?
Whyte: A serialization system that uses an Electronic Product Code Information Services (EPCIS)-certified, cloud-based server can provide centralized UID generation, management, and storage, as well as ensure interoperability with manufacturing and business systems. The cloud-based server is the central communications hub for supply-chain partners and provides mobile connectivity, so product authentication can flow all the way down to the consumer level through tablets or smartphones.