SERIALIZATION

Are Packaging Line Print-and-Verify Systems Mission-critical?

JIM CUMMINGS Written by JIM CUMMINGS
27/09/2016

New legislation will soon make packaging line print and verify systems mission-critical.

Packaging Line Print and Verify: mission-critical vs. manual alternative

More than 40 legislations and different implementation deadlines around the world related to drug serialization requirements will soon make make packaging line print and verify mission-critical systems. Most mission-critical systems today are very important to the business. We have to rely on them greatly for their information and functionality. However, most are not deemed mission-critical in the sense that manual work around and procedures, as painful as they may be, exist. A good example of this would be a truck that is ready to leave the dock with a trailer full of new products destined to a warehouse or customer, but the system is unavailable to print out the Bill of Lading. In the majority of instances there is a manual process, albeit cumbersome, that provides for the creation of a manual Bill of Lading and the subsequent “truing” of the system when it becomes available again.

New serialization regulations and a higher level of scrutinity

In the past, many inspection or verification processes of the Lot and Expiry information could be manually performed if a vision sensor was out of commission. This is no longer the case due to the new serialization regulations. There now exists an enormous business need to ensure the company does not have product returns due to unreadable codes or label text reaching the supply chain, as a new level of scrutiny will not be enforced through barcode scanning and recording of serialization data. In addressing the regulations put forth by the FDA (U.S. Food and Drug Administration) in the United States for instance, we must now store the serialization data and have it ready to present upon demand to the FDA for the next six years whether we produce in or export to the United States. Clearly, we can not store and present data we did not scan or inspect. Therefore our system must be available at all times or we cannot package products!

Critical spares strategy for print and verify

This must be viewed, as all mission-critical systems, in a proactive manner to provide a plan to deal with component failure and recovery of our ability to continue production. All devices (cameras, printers, scanners, sensors, etc.), system hardware (IPCs, HMIs, switches, drives, etc.), system software and dependent components (OS, DB, etc.) must be considered for a critical spares strategy.

It is extremely important to understand how flexible your system can be in implementing new or different components that are more readily available to resolve the current issue. If we are not able to get our preferred component in a timely manner, but can obtain a functionally equivalent replacement almost immediately, can we take advantage of that to minimize the impact of production? To avoid drops in productivity or even the need to stop whole production processes, a thorough audit of all devices and potential replacements is therefore needed before the legislation is implemented.

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JIM CUMMINGS
JIM CUMMINGS

Jim Cummings is VP Americas at Adents. He has an extensive background in instrumentation, automation and information systems for manufacturing. He also was a founding member and chairman of the Control Systems Integrators Association (CSIA).

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