Track &Trace System for Pharmaceutical Packaging Line Management

As new track and trace regulatory requirements are rolled out across different regions the Pharmaceutical Manufacturers are facing the challenge of updating their production lines to meet these changes. Initiatives in France (French coding), Turkey (ITS) and California (E-pedigree) are already in place and pharmaceutical manufacturers will need to ensure that production processes and end products comply with these new regulatory changes.

The PharmaMarker Track and Trace system solves these regulatory challenges by integrating easily into a production line either as a stand-alone product or as a component of an integrated production/packaging line and allows paperless compliance to existing and upcoming national and international regulations. The PharmaMarker conveys, uniquely marks and verifies up to 450 pharmaceutical packages per minute for the purpose of tracking individual packages through each phase of the packaging line ensuring their accurate traceability back to the point of production. The PharmaMarker provides 21 CFR Part 11 rating for FDA regulated environments according to GAMP standards.

• The PharmaMarker system is positioned immediately downstream of a cartoner
• An OCS conveyer system with flap control can convey a variety of different sized cartons along the line
• A non-contact thermal ink jet or laser print head (dual print head) imprints label information including a datamatrix code containing a unique random serialised code for accurate traceability purposes
• A Cognex high resolution vision system ensures precise verification of the label data
• An automatic reject systems uses an air knife to blow any non readable cartons from the production line into a reject bin
• LineDirector™ software manages the peripherals along the line including printers, cameras, RFID readers and hand held scanners
• Protrack™ real time traceability management software is then used to accurately record data to a PC based enterprise database solution for complete compliance with track and trace regulations
• Windows® based operation is controlled at the swing arm mounted Human Machine Interface (HMI) which is a 17 inch (432mm) touch screen
• The system has been tested to work up to a speed of 450 packages per minute
• It can be validated off-line to avoid compromising existing production line efficiencies
• The quick change mechanism has been designed specifically to enable rapid adjustment for a wide range of carton sizes

Crest Solutions' LineDirector™ and Protrack™ software suites:

The PharmaMarker system employs LineDirector production line management software to manage individual or multiple vision sensors, coding devices, checkweighers and associated equipment across automated production and packaging lines.

The system also utilises Protrack™ real-time traceability management software allowing simplified implementation of product traceability capabilities within existing infrastructures.