Serialization in Fill/Finish Plant

July 30, 20145:15 am | Posted by Admin

A leading bio-pharmaceutical corporation chose Enterprise System Partners to implement a serialization solution in their Fill/Finish plant in Ireland.

Goal:

Deploy a GS1 compliant solution implementing California serialization requirements as well as providing for easy adaptation to meet Turkish, French and other related directives.  The implemented solution has to cater for a number of packaging form factors i.e. vial, carton, bottle and shipper case.

Objectives:

  • Install & commission upgraded 2D scanning and labelling equipment to enable product tracking & label verification
  • Interface with central numbering repository and EPCIS (Electronic Product Code Information Services) system
  • Integrate with existing online MES & SCADA systems
  • Provide serialization functionality within the Warehouse
  • Validate entire system to meet FDA, IMB and European standards

 

Success Story:  ESP provided project & vendor management, technical design & engineering and validation support on this project.  Our client was one of the first pharmaceutical companies to implement a fully automated 3 level serialised product tracking solution.  The result was a successful project which now facilitates the client’s product being distributed in these regions.  The system seamlessly integrates to existing business systems i.e. MES/ERP.

Project and vendor management with technically savvy resources was key to the success of this project given the limited experience of vendors (both hardware & software) in general in deploying solutions to meet these emerging regulations within the life science industry.  Also key was ESP’s understanding of the existing MES and automation layer given the degree of integration required.

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