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PTSM: Pharmaceutical Technology Sourcing and Management
Implementing serialization on a packaging line requires a complex integration of hardware and software and often requires that new and existing systems work together.
Serialization involves the application of a unique code to a package to help track, trace, and authenticate a product. Although it may sound simple, implementing serialization on a packaging line requires a complex integration of hardware and software and often involves a combination of new and existing systems, which must work together.
"Hardware includes the printers, cameras, and material-handling machinery," explains Chris Siegele, serialization specialist at Omega Design, a provider of coders/printers, manual and semiautomatic case-packing stations, label synchronization modules, and controls integration, in an interview with Pharmaceutical Technology. He notes that the serialization-ready hardware needs to function at line speeds and adds, “Software that manages the serialization data needs to be tied to the hardware operation through controls integration and function as a seamless unit.” Software also must be capable of handling large volumes of data in real time to supply the codes to be applied, confirm correctness, and link the product to historical data, such as sources of ingredients, as well as to each packaging level from primary container to pallet load.
In-house implementation of serialization is an option. But Siegele says, "It is a disadvantage …. The in-house team is just learning as they go along. To implement, you have to stop the line and now you’re not producing product. With an outside provider, you can prove the serialization operation and ultimately have less machine downtime."
Fortunately, a number of hardware and software providers and third-party integrators have developed the expertise needed to make packaging machines, coding equipment, inspection and data capture systems, material handling, controls, and software work together to create a complete serialization system. "There are a couple of advantages to working with a single supplier when implementing a serialization solution," said John DiPalo, chief strategy officer for Acsis Inc., a supplier of supply network visibility, brand protection, and serialization software, in an interview with Pharmaceutical Technology. He explains: "There are a lot of moving parts in a serialization implementation that must all come together at the same time in order for the solution to work. One supplier managing the process has the insight to understand the complexities and the ability to coordinate all the tasks, making sure nothing is overlooked. Another big benefit is that a single supplier can help the customer see the value that serialization can bring to their business by looking at the implementation in a more holistic way."
Schubert-Pharma, a cooperative venture formed in January 2014 by Gerhard Schubert and IPS International Packaging Systems, provides that type of holistic approach. It not only supplies integration services, but also hardware and software under its TLM brand name. TLM standard components include Schubert’s VMS Packaging Machine Controller, robotic and vision systems, and electronics, which can be customized for the application.
The VMS Packaging Machine Controller integrates all functions of the packaging process to enable serialization from filling to pallet of finished product. All automation components, such as robots, scanners, cameras, and printers communicate with the VMS.
The TLM Transmodul, a single-axis rail-based robot system, conveys product and provides 100% position control. Because the Transmodul continuously defines the status of products being conveyed, it always knows what code belongs to what package. So, when cartons are loaded into a shipper, code information is recorded automatically. No camera system is needed to record and communicate code data. As a result, aggregation occurs in real time in one system. Interface issues are minimized because components receive data directly from the line management or VMS system. Fewer individual components for tracking mean simplified qualification. Other benefits include consistent documentation and a single user interface.
Regardless of whether integration is done by an original equipment manufacturer, software provider, third-party integrator, or in-house, DiPalo says pharmaceutical manufacturers, "need to look at serialization from a few different angles. First you need to understand that adding serialization to a line will change your work processes, so change management and training are essential to a successful rollout. Second, the process of serialization does not end once product leaves the packaging line. You need to understand the downstream implications of adding serialization to your supply chain and how you are going to handle the processing of this serialized data in your downstream activities. From a tactical perspective, it is important to fully map out all of the touch points on the line where you will need to manage serialized data, not only how you are going to get serial numbers on items and cases. Other activities like rework of rejected product and managing of aggregation data become very important in making sure that your overall productivity is not impacted by the implementation of serialization," he concludes.