The implementation of serialization is today one of the biggest challenges in the pharmaceutical industry. The list of requirements is long and can range from coding of single items to the central management of multiple packaging lines or sites.
Serialisation encompasses the end-to-end application and the data technology to generate and record serial numbers during the manufacturing process. When the pharmacist, as the last link in the value chain, sells a prescription medicine to a patient, the package code is read in the pharmacy and sent to a central data base to be checked and verified.
Serialization is the process of assigning and applying a unique identification code to a product. Aggregation defines the relationship between multiple items within a product shipment, such as cartons, cases, and pallets. Together, these two concepts form the foundation of “Track-and-Trace,” which documents a product’s current and past locations throughout the supply chain. This ability to track a product’s whereabouts and trace its path is the start of a safer and more efficient drug supply chain.
All serialisation and aggregation systems can also be integrated as OEM solutions into already existing processes required for packaging or labeling systems (e.g., for bottles and cans).
Serialization has many benefits, such as it encodes packages with expiration date, lot code, serial number, GTIN, and a GS1-DataMatrix symbol , Used to track products for anti-counterfeiting, Provides regulatory compliance, Track and trace capability throughout the supply chain, Consumer protection, Brand protection etc.
Utilizing Print and Check Station, cartons will be printed using a Thermal Inkjet (TIJ) printer. The vision system will inspect all the data printed on the carton (expiration/lot/serial number/GTIN/2D matrix code). Cartons that do not pass inspection will be ejected. At bundle station, vision systems read and conform all of the serialization codes after the bottles or cartons (bundles or individuals) are placed into the case. Once the total number of bottles or cartons is scanned and confirmed, the system prints a case label from dedicated printers and the label is applied to the case.
The series of machines in the Quality System provides a format independent aggregation for all packaging levels (sets, cartons, palettes) tailored for the individual requirements of every customer. QS Enables the consolidation of the serial numbers of multiple individual packs into a separate unique serial number for the set in addition to semi-automatic aggregation of manually repacked cartons, where the operator places previously aggregated sets lengthwise into the shipping carton.
IT and secondary packaging experts work with the client to meet your specific requirements regarding interface, transfer protocol, transfer message, and reports. They utilize EPCIS (Electronic Product Code Information Services) as the standard data-exchange interface to share information, which we can adapt for either your proprietary IT or cloud-based solution.