Tracing a pharmaceutical product through the entire supply chain means that the movement of an individual product (unit level traceability) is captured and documented along the supply chain using a piece of unique serialization information. The history and location of an item are recorded using a marking and tracking system, and records provide information on the product entry and transfer points into the distribution chain.
Several countries have instituted legislation and regulations aimed at preventing counterfeit and illegally imported or stolen drug products from entering the supply chain.
Governments and companies worldwide are challenged with:
Pharmaceutical companies need to implement changes to their production lines to comply with track & trace regulations. Compliance can be successfully achieved with the help of our competent, reliable, and experienced team at RN Mark.
Using an interoperable system improves the detection and removal of potentially dangerous drugs from the drug supply chain, and determines whether a suspect product is illegitimate. By deploying track and trace systems, manufacturers can block revenue losses and reduce the risk of counterfeit or recalled drug products from reaching consumers.
The initial step in a regulatory compliant, end-to-end Track & Trace solution is the marking of unique data on the product package.
Serialization is marking a unique identity (serial number) together with manufacturer information, production, expiry information, and other variable data, embedded in a 2D barcode (data matrix). Serial number information is sent to the coding & marking printers from a central database, which maintains this data and other production information and facilitates efficient information flow between trade partners.
In preparation for shipping, finished products are aggregated into larger batches. The first level of aggregation consists of placing several single packs together to form multipacks.
Each multipack is marked to identify the serial numbers of the individual items it contains, and a unique serial number is assigned to and printed on each multipack.
Subsequently, a certain number of multipacks are aggregated to a case, and finally, multiple cases are placed together on a pallet. At each aggregation level, the container is marked with a unique serial number and embedded with the serial number information of each item it contains.
Throughout the marking and aggregation process, several cameras verify the readability of coding on the packages, and non-complaint ones are automatically ejected from the line.
RN Mark’s compact coding, high through-put coding, and marking printers obtain serial number information from company or manufacturing servers. Each bottle or case is marked with an encoded, unique serial number using a Data Matrix.
All data printed on cases and labels must be verified for accuracy and readability. A sophisticated vision system consisting of multiple cameras verifies the quality and conformance of the Datamatrix. The vision system is a part of the material handling mechanism and guides the products. An integrated and precise reject system reliably removes failed items from the production line.
After serialization, a gantry (linear) robot picks the bottles or case and stacks them to form a bundle or multipack. A camera captures the serial number of each item in the pack, recording the link between parent-child packages. A label containing a unique serial number for the bundle and a 2D barcode (embedded with the serial number information of its contents) is applied to the bundle.
Another camera records the serial number information of each bundle comprising a carton. A label containing a unique serial number for the carton and a 2D barcode (embedded with the serial number information of its contents) is applied to the bundle.
In the final aggregation stage, cartons are stacked on a pallet. A label containing a unique serial number for the pallet and a 2D barcode (embedded with the serial number information of its contents) is applied to the bundle.
The aggregation steps during the production process establish the parent-child links between the aggregated component (parent) and its content (child), & production data is updated in real-time.