The directive concerning the regulation and safety of medicines has seen Europe and the United States at the forefront of the fight against counterfeiting to guarantee consumers the right to receive genuine medicines.
In 2013, the FDA (Federal Drug Administration) introduced the UDI (Unique Device Identification) system, which requires the identification of each medical device along the entire supply chain. To comply with this, the manufacturers of medical devices and their suppliers must mark each product with a unique identifier consisting of 4 data elements: product code, serial number, batch number and expiration date. The unique identifier must be inserted inside a barcode or a DataMatrix, be visible on the package and readable by both the human eye and optical readers.
In Europe, the anti-counterfeiting directive entered into force in February 2019 has seen the implementation of the serialization process of pharmaceutical products, which provides for the adoption of the unique identification for all medicines subject to medical prescription, and of an anti-tampering device to guarantee the integrity of the package. This guarantees the inviolability of the packaging and the authenticity of the product, and allows to trace its path in case of negative events to protect the safety of consumers.
The design logic behind Zanasi inkjet marking systems and their flexibility allow integration into the complex track & trace process of pharmaceutical devices. Through the collaboration with qualified and certified partners we provide complete solutions consisting of a serialization station and the related data aggregation management system. The complete station can be supplied in single modules and the marking systems can be integrated into the different modules and interact with the devices of which they are composed, for precise and readable coding of the different types of substrates and drug packs.