Pharmaceutical cartons might be serialized by applying 1D/2D code on them or marking the cartons through RFID technology. However, serialization has to be implemented according to the market dynamics of that country where the medicine is sold. Otherwise, the activities of traceability and sales will be interrupted. The rules (DSCA, EU-FMD, CRPT, etc.) are determined by the legislators that regulate the market. No countries in the world except for China and Iran have formed serialization operations based on GS1 standards. Russia has added a crypto code into its regulations by adhering to the standards and also made a revolution in its serialization process. In order to access the updated regulations of the countries for the serialization process, please click the link here.

The most common print technology which is used in serialization operations is Thermal Inkjet technology. Other techniques which have been preferred are laser, label applying and continuous inkjet. The most important quality of thermal inkjet technology which makes unique is its high speed and print resolution. Although TIJ seems to be an expensive solution from the point of view of ink, it is nearly the same price considering maintenance and OEE cost.

Applying Data Matrix in GS1 Standards on cartons through TIJ technologies is the most common marking method. The print quality depends on some parameters like the surface, the quality of the carton and dust density in the environment. However, when compared to other technologies, the TIJ method is a much easier technology owing to its practical adaptation.

We have objectively prepared a comparison table for TIJ and LASER technologies that are often used for serialization in the pharmaceutical industry. You can easily compare both technologies in this chart.

Data Flow For Pharmaceutical Carton Serialization

Data is the most important concept in all the stages of serialization operations. The errors resulting from data may cause irreparable problems. Thus, it is vital that the data that will be used in serialization operations are managed right and the data collected at the end of the serialization are reported well.

The data used for serialization might be produced in the serialization system with a different algorithm. But the important thing is to prevent duplicated data when different pharmaceutical carton serialization machines are processing simultaneously. The most popular method for this is to add prefix and suffix features into the data whose serialization is made. The sustainability of this method is not so easy for pharmaceutical manufacturers who have many plants and serialization lines.

The most accurate data management is to provide forming serial numbers from one center by using a system that is equal to LEVEL 3. The data should be transferred into serialization machines through a work order relationship. In case of more than one factory, it is advised that the data which will be used in the plant should be assigned on plant base through a system equal to LEVEL 4.

Rigid and Flexible Mechanism

Many cartons which have different geometrical shapes are produced in pharmaceutical medicine lines. The cartons which have different sizes and weights are asked to be serialized in the same quality. Hence, it is essential that there should be a rigid and flexible mechanism in serialization machines.

Some factors such as engine noise and vibration may reduce the print quality. So, you should take these conditions into consideration during your operations.

VISIOTT TPS will provide you with professional service support and hardware for Pharmaceutical Carton Serialization which we mentioned for the subjects above.