Seven Steps for Serialization-Ready Systems

If your equipment is not ready, it’s time to get it ready

By Joe Whyte, Global Serialization Lead for Rockwell Automation

Pharmaceutical counterfeiting is on the rise — and a growing health and safety issue with deep consequences for consumers and drug manufacturers alike. A number of factors contribute to counterfeiting, including:

• Increased 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. Drug makers can then identify and track each unit throughout the supply chain, providing greater visibility and traceability.

But before this can happen, drug manufacturers need machines that are designed for serialization. The typical process involves printing, product handling with serialization aggregation and product traceability. These machines should be information-enabled so they can receive serial numbers from a manufacturer’s IT layer, print and inspect the codes on the product, then feed the authenticated data back up to the IT layer or manufacturing execution system (MES). For pharmaceutical manufacturers, specifying machines that are serialization-ready will be the obvious choice.

Serialization requires a comprehensive 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. Here are seven actions to help ensure production equipment is serialization-ready:

1. Migrate to an off-the-shelf control system
When building serialization-ready machines, OEMs generally specify commercial, off-the-shelf technology that’s modular, scalable and uses standard communication and protocols. Pharma users with “black box control” (i.e., custom control systems) often face issues with long-term support, parts and knowledge transfer which may 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 Pharma users time and money as new legislation is passed.

2. Specify modular and scalable machines
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, users can take advantage of modular machines using commercially available technologies for each step of the serialization process. As mentioned, 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. Look for industrial-managed switches to help properly segment networks. 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, handheld barcode readers 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. Select machines and integrators who practice proactive support
To assure production line OEE, the OEMs Pharma selects need to stay ahead of the curve to meet current and future needs. Those partnering with a supplier of modular and flexible control and information systems suppliers can deliver serialization-ready machines that meet existing regulations and are easy to modify for future requirements.

Because of these systems’ complexities, consider purchasing from OEMs partnering with suppliers that 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.

7. Buy machines that ease validation

Before purchasing and integrating a new machine into the line, end-users need assurance that the machine will do what it is designed to do. Original Equipment Suppliers need 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 reusable template for the validation documents.

By following these seven tips, pharmaceutical manufacturers can specify and purchase serialization-ready machines that will allow them to more easily manage compliance, recalls, and ultimately help regulators fight the counterfeiting issues.

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