What to look for when adding Serialization to a pharma packaging line…


If you are in the market for a serialization solution for your pharma packaging line then consider these questions while selecting your solution…

  • What information needs to be captured?
  • What kind of labeling is needed to document the package?
  • Do we need to cater for unit, pack and pallet levels of packaging?
  • Can the solution handle sequential and random serial numbers?
  • What standards does the solution adhere to in terms of serialization? E.g. GS1 standards

For the packaging equipment the hardware should fulfill the following requirements:

  • Be adequately efficient. E.g. Apply x labels per minute
  • Orientation independent ability to print, apply and verify
  • System rejects labels where verification is not successfully obtained. This information should be processed through the system to allow for the provision of analytics around errors
  • Have acceptable durability. I.e. can operate 24 x 7 x 365
  • Be scalable. I.e. Can expand with your operation
  • Allow for the automation and manual application of labels
  • Handle products of all applicable sizes
  • Should not impede packaging line performance and operation. E.g. Can you switch the system on / off without affecting the packaging line?
  • Allow for the reprocessing of labels
  • The system shall have a full Disaster Recovery Plan (DRP) in place. E.g. Fail over, UPS power
  • Serialization system can shut down packaging line equipment if serious errors are uncovered E.g. Communication, consecutive failures
  • Sufficient security provided for operators, supervisors and maintenance folks
  • Complete documentation of the solution has been provided
  • Is support for the system strong and timely? I.e. Is the solution stable, widely used and are there enough support folks to adequately support the solution?

These considerations need to be taken in to account when adding serialization to your packaging line. Certainly with the California e-Pedigree law coming ever closer, these considerations needs to not only be addressed but acted upon. I am curious to hear from those who have provided solutions in this space or from those that have implemented solutions in this space.

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