When serializing your products, you need to double-check the quality of your printed codes to ensure your supply chain can read them.

Many CMOs and pharmaceutical companies are implementing serialization and aggregation solutions to comply with legal requirements. Being compliant in most cases however does not only mean serialization. It also means you have to provide a lot more information on your packaging, human readable and in the form of a barcode, datamatrix or other.  Many companies find they have to alter their artwork in order to accommodate the larger amount of data that needs to be printed to meet these new requirements. Mark and verify systems will thus become mission-critical, so you are well advised to check, check and check again. While there are a number of resources to help understand printing quality metrics and barcode grading measurements at places like GS1AIMANSI, and ISO we would suggest a fairly simple first step.

Keep it simple

Just get a low dollar handheld barcode imager. “What?” you may ask now. Well, consider the ecosystem that will scan and either accept the product or return it at great loss to the manufacturer. Today’s modern machine vision cameras and industrial barcode scanners are able to read codes that are so small and printed with a very low print quality that will do little to help you in the grand scheme of things. In fact, in many cases it will lead you into a great deal of trouble if left unchecked.

The reality is that the supply chain outside of packaging facilities very rarely uses any form of vision equipment. The bulk of the scanning is and will continue to be performed by hand held devices. Many of these are pre-existing devices. And those are far less capable of reading extremely small codes and/or poor print quality symbols than their industrial fixed mount brethren or machine vision cameras.

Ensure your supply chain can read your barcodes

Using a low dollar, far less forgiving device to test ensures that your trading partners, who by the way have very excellent scanning equipment, and, more importantly their trading partner network can reliably read the codes as well. All through the supply chain. Returns from improperly labeled (which is what most unreadable codes will be classified as) products will happen. After the trading partner network performs all of the reverse logistics processes needed to execute a product return it is indeed the manufacture/packager who will pay.

On the bright side it is not often when restricting yourself from spending as much money as you normally would on something for testing can in fact raise your quality level. Simply by actually reducing your requirement level for a testing device.


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).


Serialization, aggregation, coding formats – global challenges for the Pharma industry
Serialization, aggregation, coding formats – global challenges for the Pharma industry
With more than 40 legislations in place or to come, compliance is becoming more and more challenging for pharmaceutical companies: different deadlines, different serialization-, aggregation- and coding requirements, suspended and changing directives.
Enforcement sanctions of DSCSA postponed –  opportunity to go beyond compliance
Enforcement sanctions of DSCSA postponed – opportunity to go beyond compliance
The US Food and Drug Administration (FDA) seems to be willing to give the pharmaceutical industry an additional grace period concerning the DSCSA.