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PCI Reveals Serialization Strategy

Contract packager PCI discusses its serialization systems hierarchy and how it yields benefits both internally and for its pharmaceutical/biopharmaceutical companies around the globe.

PCI’s Justin Schroeder (right), Executive Director, Marketing, Business Development & Design, and from Ray Hook, Senior Manager, Global Serialization Services.
PCI’s Justin Schroeder (right), Executive Director, Marketing, Business Development & Design, and from Ray Hook, Senior Manager, Global Serialization Services.

During a recent on-site visit to PCI’s Rockford facility, and via a subsequent question-and-answer session, Healthcare Packaging discussed the contract packager’s serialization efforts past, present and future. The answers below come from Justin Schroeder, Executive Director, Marketing, Business Development & Design, and from Ray Hook, Senior Manager, Global Serialization Services.

Describe the overall hierarchy of PCI’s serialization systems.

There are essentially three levels of the hierarchy and data flow. The highest level is the B2B interface between the client and PCI, effectively a “bridge” between the client’s Level 4 system (EPCIS) and PCI’s Level 3 (site systems). This is where information is shared at the onset of the packaging run as well as the completion of the finished batch/lot.

To initiate the process, PCI’s system will alert the client that we need the bulk serialized number data to execute the packaging run. PCI’s system is mapped such that a single interface with the client will enable their system to “talk to” any of our global sites. We have engineered our interface with a flexible approach such that clients can use several file formats for data exchange. This prompt will draw a pool of serialized codes for use in the packaging operation.

These codes cascade through our Antares system, from enterprise level down to line level for use in the batch. In the packaging process codes will be utilized in the packaging operation and applied to packages and ultimately “commissioned” as good codes. PCI also establishes aggregation, the parent-child relationship between the saleable unit and its secondary/tertiary packaging.

Some codes may also be designated as scrapped or waste codes. In the release process, both the commissioned codes and the scrapped codes will be transmitted from the line level to the enterprise level, and then ultimately back to the client via the network interface, providing for downstream authentication.

What type of investment has PCI made in serialization?

PCI globally operates in excess of 250 packaging lines. While some of those lines are primary packaging operations that are largely unaffected by serialization, others are impacted and investments are happening to add serialization capabilities for a variety of drug delivery forms. PCI is expanding serialization capabilities, both integrated operations as well as standalone “FlexSuite™” capabilities, at each of its packaging sites across North America and Europe. It is a significant ongoing multimillion-dollar investment, which we project will continue well into 2017 and beyond as the demand continues to rapidly increase.

How many total packaging lines/suites are equipped to handle serialization within PCI worldwide? What is the ultimate goal? How often do they run, what is their output, and what are the company’s goals for them?

PCI supports packaging for a variety of drug product markets, including Over-the-Counter medicines, branded and generic ethical prescription drugs, as well as animal health products, medical devices, and others. We support human health medicines destined to more than 100 countries around the world. Track-and-trace regulations are focused to the “saleable unit and case” for ethical drugs, with the U.S. requirements coming to bear formally in 2017 and the European Union in 2019/2026.

We anticipate this will require serialization for a large proportion of our packaging lines over the next 18 to 36 months as the demand continues to increase. By the end of 2015, PCI had tripled their serialization capacity. We have been pleased in the ability of the Antares equipment to integrate into our existing processes with no overall impact to Overall Equipment Effectiveness, so our output yield has been typically neutral.

As a contract packager, flexibility is always critical. How does flexibility fit into PCI’s overall serialization strategy?

In evaluating serialization equipment providers and integrators for our global platform, flexibility was paramount as a factor of our vendor selection. Antares is a proven technology platform, having already executed 300 plus global installations at the time we executed our evaluation more than two years ago.

The modular nature of their equipment and ability of their platform to be adapted and redeployed for varying applications was a critical element. This has allowed us to integrate their technologies into our high-speed automated and multistep packaging lines, as well as utilize their equipment for our ala carte FlexSuite operations as an adaptable solution for varying sizes and packaging configurations.

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INTRODUCING! The Latest Trends for Life Sciences at PACK EXPO Southeast