Pharmaceutical counterfeiting is on the rise – and a growing health and safety issue with deep consequences for consumers and manufacturers alike.
A number of factors contribute to counterfeiting, including:
- Increasing involvement of under-regulated wholesalers and repackagers in the supply chain,
- Proliferation of online pharmacies,
- Counterfeiting technology advancements, and
- Increased importation of gray-market medicines.
To combat counterfeiting, pharmaceutical manufacturers are putting serialization processes in place – whereby each item is assigned and marked with a unique serial number. Manufacturers and retailers can then identify and track each unit throughout the supply chain, providing greater visibility and traceability.
But before this can happen, manufacturers need machines that are designed for serialization. These machines are information-enabled so they can receive serial numbers from a manufacturer’s IT layer, print and inspect the codes on the product, and feed the authenticated data back up to the IT layer or MES. For pharmaceutical manufacturers, machines that are serialization-ready will be the obvious choice.
Serialization requires an integrated control and information system to track-and-trace products in manufacturing and through the entire supply chain. This system must be designed to address the increasing threat from vulnerabilities, such as counterfeit and misbranded prescription drugs. The process starts at the manufacturing and packaging line, with serialization-ready machines.
Here are seven actions machine builders can take to help ensure their machines are serialization-ready for customers:
1. Migrate to an off-the-shelf control system: When building serialization-ready machines, OEMs need commercial, off-the-shelf technology that’s modular, scalable and uses standard communication and protocols. Users with “black box control” (i.e., custom control systems) often face issues with long-term support, parts and knowledge transfer that make it difficult to accommodate new serialization legislation. Off-the-shelf control and information technology – such as vision, printing and checkweighing equipment, MES software and an information-enabled programmable controller – can save customers time and money as new legislation is passed.
2. Build a modular and scalable machine: A modular machine combines serialization data management with high-speed device management to help conform to current and potential regulations, without compromising Overall Equipment Effectiveness (OEE). To cater to varying legislation, end markets and cost profiles, end users need modular machines using commercial off-the-shelf products for each step of the serialization process. The typical process involves three stages: printing and verifying, product handling with serialization aggregation, and finally product traceability with integrated data systems that share information with the operations, IT, quality, finance, and supply chain business units.
3. Examine the machine’s data segmentation capabilities: The data flowing through the serialization process needs to be kept secure and segmented. OEMs can use industrial managed switches to help customers properly segment their networks. The managed switches can help these sensitive applications run securely and reliably on an EtherNet/IP™ network, while providing customers with easier access to manufacturing metrics.
4. Choose a control system designed for high-speed, mass data handling: A serialization-ready machine’s control system should include an operator interface integrated with a programmable automation controller via a dedicated Ethernet control network architecture, for streamlined data communication across the end-user plant. The system should provide for the generation, randomization, aggregation, synchronization and management of serial numbers on all product-packaging levels. It should be in accordance with EPC Information Services (EPCIS) standards and support the transaction of serialization data to third-party systems, such as SAP, IBM and contractor systems. It also should support transactions to global-hosted serialized data vaults and databases from authorities and government organizations.
5. Allow for device-independent integration: Printers, vision-inspection camera systems, handhelds and RFID equipment should be able to integrate with the control system for all serialization line-level components from one cabinet. This add-on capability helps ensure minimal interruption of the production process and simplified validation. Integration of high-speed coding and verification capabilities also should meet industry standards, including EPCIS.
6. Take a proactive approach to supporting customers: OEMs need to stay ahead of the curve when meeting current and future customer needs. By partnering with a supplier of modular and flexible control and information systems, OEMs can deliver serialization-ready machines that meet existing regulations and are easy to modify for future requirements.
OEMs also can partner with suppliers to provide remote-support services. Once a production line is serialized, all assets within the serialization system become production critical. If any part of the system stops working, the entire serialization process and subsequently the entire packaging line must stop. End users often call their OEM to dispatch a service technician if machinery isn’t working properly. For OEMs doing business on a national or global scale, this type of support can be costly and time-sensitive. Working with a supplier that can service a machine in areas where the OEM cannot cost-effectively send resources helps cut operational costs throughout the life cycle of equipment.
Remote support also can be an additional revenue source for OEMs. For example, using the Virtual Support Engineer™ service from Rockwell Automation allows OEMs to respond to critical situations and execute preventive maintenance remotely, while realizing a new source of revenue through aftermarket support.
7. Build machines that ease validation: Before operating a new machine, an end user needs to test that the machine will do what it is designed to do. Prior to that, the OEM needs to do the same. Building machinery with a modular, standardized control and information system can help ease the validation process for both parties because OEMs can create a re-usable template for the validation documents.
By following these seven tips, OEMs can deliver serialization-ready machines that allow end users to more easily combat product-counterfeiting issues. Building serialization-ready machines is a powerful way for OEMs to differentiate themselves and uncover new revenue sources.
For tips on technology to use when building serialization-ready machines, read the Serialization Matters newsletter.
Virtual Support Engineer is a trademark of Rockwell Automation Inc. EtherNet/IP is a trademark of ODVA.