Today, there is no individual identification of containers. In the case of a problem in a process step, manufacturers are not able to define exactly which products may have been impacted and so they adopt either an “over segregation” or “full batch write off policies”. This impacts the fight against drug shortages as well as resulting in lost or missed revenues.
In the same way, the cause of a reject from an automated inspection system is unknown thus preventing product and process optimization. If the containers were marked and the reading of this container was integrated with the inspection machine the cause of the reject for each individual container would be known (e.g. particles, CCI, etc.). This data would help to drive more detailed root cause analysis and improvements in machine utilization.
This approach has been validated by a cross-section of the pharmaceutical industry and the business case. At the same time, there is a convincing business case for the improvements in both filling lines and automated inspection machines.
This presentation discussed the approach, process steps, and initial test results of how this can be achieved today.
Core Team Leader
Tod Urquhart has more than ten years’ experience of working in the field of product serialisation and traceability. He has extensive knowledge of planning, managing, and delivering cross-functional serialisation projects for pharmaceutical regulatory compliance as well as product interaction and traceability. Previous projects include working with Pfizer, GSK, Lucozade, Red Bull, and Danone.
Tod is currently the Core Team Lead for the Stevanato Group project which is working on Primary Container Traceability [PCT]. The project covers a range of areas from developing new printing processes through systems integration to commercial modelling and the creation of a common standard for the Pharmaceutical industry.