Printing and marking solutions for the pharmaceutical and medical industry
Serialization and traceability for pharmaceuticals and medical devices
The pharmaceutical and medical sector is among the most highly regulated in the world regarding marking requirements. EU Falsified Medicines Directive 2011/62/EC and its delegated regulation EU 2016/161 require the serialization of every pack with a unique code registered in the NMVS, along with a batch number, expiry date, and anti-tampering feature (ATD). Medical devices must comply with EU Regulation MDR 2017/745, requiring the application of the UDI (Unique Device Identification) in both human-readable form and DataMatrix code. Laser, TTO (thermal transfer overprinting), and high-resolution inkjet technologies are the most widely adopted solutions. Explore UDI solutions for medical devices.
GMP compliance and pharmaceutical inspection systems
Pharmaceutical marking must be carried out in GMP-compliant environments, with systems qualified according to GAMP5 principles and full traceability of every process parameter through IQ/OQ/PQ validation. Automated inspection systems perform 100% verification of printed code accuracy, readability, and content compliance against data expected by the MES system. Integration with NMVS serialization systems is a de facto requirement for pharmaceutical manufacturers in Europe. Explore inspection and quality verification systems compliant with pharmaceutical regulations.
