Serialization/Track & Trace


A serialization solution, with flexible track&trace services and products, enable your company to comply with current and future legislation requirements regarding e-pedigree of drugs, while delivering better supply chain control and optimization of your operational processes.The operation of uniquely identifying each product as a unit, so that all the actions taken place from the manufacturing to consumption can be tracked and traced, is called serialization; where Track&Trace stands for the operation in which the past and current status information of each product is recorded and notified in each step into regulating bodies. Serialization is the key concept in pharma industry against counterfeiting by providing the uniqueness of each drug unit, while preserving patient safety and profitability of manufacturers. Thus, nowadays a lot of countries are regulating production and transfer processes in phrama industries to enable authentication of e-pedigree by means of Track&Trace methods using different technologies.


As Turkey is the first and only country in the world where all stages of pharmaceutical serialization are applied in all stakeholders of the industry the products have been successfully implemented in more than 60 customers, including manufacturers, contract manufactures, importers, pharma logistics services suppliers, warehouses and distribution centers. Track&Trace solutions enable single unit, bundle, case and pallet serialization through production and packaging processes in a seamless manner. Either you need an online or offline implementation, comprehensive solutions can provide it with its flexible product and service lines.


Track&Trace/Serialization Solutions provide 2D code printing, verification and grading according to ISO-15415, rejection of serialized items in compliance with CFR 21 Part 11.

 


 

At all levels of serialization all printing and vision equipments, PLC controlled devices with robotics parts have to be connected into a centralized software to manage the whole system, gather all the information created and make necessary notifications together with analysis and reporting tools.


  • VisioPharma Serialization Software is an easily deployed standalone serialization solution which can be integrated into variety of ERP/MES and WMS softwares with its flexible features.
  • Generation of 2D code that includes GTIN, Serial Number, Expiry Date, Batch Number
  • Depending on setup, serial number created in other systems can also be imported
  • Supports data types such as GTIN, SGTIN, SSCC as per GS1 and EPC standards
  • Application of this information into each unit, bundle, box and pallet by printing or labeling in the form of datamatrix and human readable code as per GS1 standard
  • Verification of the codes and creation of hierarchical database in parent/child realtionship
  • Flexible database management system securing full audit trail
  • Management of notification and communication processes into regulating agencies to enable traceability.
  • Management of analysis and report processes
  • Can be configured to make notifications manually or automatically when work order is completed.
  • Includes tools for audit trailing and reporting processes
  • Can configure all lines easily and quickly for different types of cartons
  • Controls all lines together with code printers, cameras, servo motors and robotics mechanisms
  • Can be deployed in the cloud to provide centralized management, flexibility and scalability 
  • Creates or changes parent/child relationship in aggregation process and disassociates a parent serial number from its child when necessary
  • Can exchange e-pedigree data in XML files or any other form between supply chain partners
  • Compliant with existing and adaptable to future legislation requirements

 "VisioPharma InkJet Station" is an ideal solution to 2D code cartons by using TIJ printing system. Every coded item is inspected with smart cameras to verify datamatrix and grade the quality. Using optional OCR/OCV, human readable texts and 2D codes can be cross checked to further provide data integrity. PLC controlled devices enable non-verified or defected items to be rejected before the end of line.


  • Item level serialization for carton
  • Available for both online and offline production lines with different models
  • High performance inkjet printing for 2D codes and human readable text based on TIJ technology
  • Verification and grading of 2D codes
  • Verification of human readable text by OCR/OCV
  • Self contained conveyor with carton handling mechanism that positions and holds carton perfectly in different sizes
  • Flexible printing head and camera positioning mechanism suitable for a variety of carton sizes
  • Rejection of low graded or faulty cartons  
  • Minimum setup and maintenance
  • Servo motor controls with high consistency
  • Optimal printing speed at 60 mt /min
  • Temperature controlled automation cabinet
  • Rejection with both nozzle and piston mechanism
  • Startup line cleaning by rejeceting all items into reject box if there are any on the line
  • Securely covered printing and inspection


"VisioPharma Labeling Station" is an ideal solution where printing on cartons is not possible or effective. Optional robotics controlled positioning mechanism provides easy adjustment of labeling point and minimizes setup time when different sizes of cartons are needed to be labeled. Labeling solution can be a good complement to VisioPharma InkJet Station to have more functionality on a single line which is suitable especially for importers, CMO’s or pharma logistics services providers.


  • Provides extreme flexibility to importers, contract manufacturers and logistics services suppliers that deal with different manufacturers’ products
  • Available for offline item level serialization as standalone or as an add-on option to VisioPharma InkJet Station
  • Can handle cartons with a variety of size and bottles or round containers
  • Verification and grading of 2D codes
  • Verification of human readable text by OCR/OCV
  • Enables application of RFID tags


"VisioPharma Switching Station" is ideal solution to create parent/ child relationship manually in bundles or cases when located next to VisioPharma InkJet or Labeling Station either in on-line or offline applications. It can also be used as a stand alone unit with a smart camera for creating hierachical data of already serialized items in distribution warehouses or logistics services providers.


  • Can be added next to VisioPharma InkJet Station or VisioPharma Labeling Station for continuous aggre gation operations or can be run offline to create bundles or cases to build aggregation tree in parent/child relationship.
  • Easily configurable for different bundle and case sizes.
  • Enables coded and verified items to be switched into different collection zones to create bundles or cases
  • Includes computers with touchscreen monitors and label printers in each operator zone to manage the operation in convenient manner

 

 

"VisioPharma Aggregation Station" When item level serialized products are placed in bundles or cases prior to palletizing, storing in warehouses as is or shipping into next stake holder in the supply chain, it’s necessary to identify which items are packed together in order to build hierarchical database by means of parent/ child relationship.

  • VisioPharma Aggregation Station is an ideal solutionwith its unique design and specifically developed vision algorithm and image processing library for high performance reading and efficient use.
  • Enables manual aggregation of multiple cartons, bottles or bundles to create parent/child relationship in cases or pallets
  • Built-in vision solution designed with special algorithms to be able to read number of 2D codes at a fraction of time
  • Includes computers with touchscreen monitors and label printers to manage the aggregation process in quick and user friendly way
  • 400 mm x 300 mm scanning area, which can be extended with multiple camera configuration.
  • Equipped with computers, touchscreen monitors, 2D readers and label printers
  • Can be integrated with wireless handheld computers that scans 2D code or that reads RFID tags

Visionera is independent subsidiary of AGE Group, which specializes in pharmaceutical serialization solutions. Having inherited profound experineces of “Turkish Pharmacuticals Track and Trace System (İTS)”, which is the first and only pharmaceuticals e-pedigree project that requires all stages of track and trace processes to be applied in the world, from AGE Group; Visionera provides diverse solutions in emerging serialization and drug track & trace implementations of world’s pharmaceuticals industry. Due to in-house production of all machinery and software components, VisioPharma Serialization Solutions are customizable with coherent integration for turnkey projects. Therefore, Visionera can provide either off-line or on-line solutions to be integrated in existing lines, as well as new plant installations. VisioPharma Serialization Solutions from Visionera are compliant to current legislations like Turkish İTS, French CIP13, California 2015 e-pedigree and are adaptable to future requirements with its flexible structure.