Design and Implementation of a Track n trace 2D Multi Scanner Bulk Code Reader for Pharmaceutical Packaging

Abstract

With various compliance initiatives surrounding the traceability of medical drugs coming into prominence and with federal regulations becoming more stringent, there is a need to efficiently manage the supply chain process involving drug packaging. To enable traceability of the drugs being packaged, many manufacturers are implementing barcoding of product labels which contains a minimum of the attributes namely GTIN, lot number, serial numbers, expiry date, manufacturing dates, etc., to enable traceability of the packaged item. Currently, manufacturers are looking for ways to keep their supply chain moving at an efficient and optimal process. One of the challenges was to build automated equipment providing a well-defined and properly structured framework for functioning, designing, and implementing of Track N Trace Counterfeit Risk Management (CRM) application to increase the speed of the aggregation with the child-to-parent aggregation and generation of online case labels after the required child's Quantity in Multi carton aggregation station. Track N Trace Counterfeit Risk Management (CRM) allows the manufacturers to establish the parent-child relationship during packaging their drugs. Also, various guidelines US Drug Supply Chain Security Act (DSCSA), EU regulation (Falsified Medicines Directive-FMD), Brazilian Health Regulatory Agency (ANVISA), Indonesia's National Agency of Drug and Food Control (NADFC), India’s Directorate General of Foreign Trade - DGFT, and Australia TGA will need to be integrated into one single source of equipment that can meet with their barcoding regulation for tracking of drugs packed. Machine Vision systems are finding themselves in use in the pharma machinery and the "multi-carton" equipment that has been built for implementation for pharmaceutical packaging uses the vision systems architecture. We aimed to build a counterfeit risk management software solution that ensures compliance with various regulatory agencies by building a common framework that can be extensible for any further changes to the guidelines and/or additional regulatory guidelines from other countries. Lots of design architecture work has been refined through continuous process improvement practices and we developed a software tool that improves efficiency and requires minimal changes to the current manufacturing/packaging supply chain lines.