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Exploring the Hidden Challenges of Serialization

Part I of a three-part series looks at decoding and verifying serialization to meet the FDA’s Drug Supply Chain Security Act.

Serialization has created some strange new partners for pharmaceutical companies. Not the least of which is the new relationship between a pharmaceutical customer and their marking and coding provider. The type of information being printed and the burden on that information being printed correctly and legibly has made the printer on the production line a potential bottleneck if problems are present.

Domino has identified three hidden challenges of serialization that go beyond the printing equipment:

  • Decoding and verifying
  • Substrate material
  • Product handling

This three-part series of articles will delve into each of those items in depth to provide information to determine if your production line is ready for serialized printing—or if one of these topics is going to stop you from putting product out the door.

In the DQSA world, printers are being asked to do more. Be it a laser, a thermal-transfer ribbon printer, or a thermal inkjet printer, more data needs to be put down, and that data needs to be embedded into a readable and gradable 2D Datamatrix barcode. For DSCSA purposes—that is typically being printed onto a folded box or onto a label for syringes, vials, or bottles.

But what does that mean—reading vs grading?

Reading a barcode is what happens in your grocery store every day, or with your smartphone, or when picking up prescriptions at a pharmacy. Reading is verifying presence and that your reader can identify what is printed. Why not stop there? If the barcode can be read, should that be enough?

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