Serialization for Pharmaceutical Cartons

Serialization may be defined as assigning a unique serial number for each of carton of the pharmaceutical products. This unique serial number is achieved by applying 1D/2D code on the cartons or marking the cartons through RFID technology. After applying a unique serial number on the carton, it should be checked whether this process is done right. The cartons whose unique serial number is not right must be rejected from the production line according to the pharmaceutical industry that implements the GMP rules firmly.

Assigning unique serial numbers on the pharmaceutical cartons is only a small part of the serialization process. Here, the greatest challenge is to manage the data correctly which is used during the process of assigning a unique serial number for cartons. During the process of creating, applying and reporting data, it is necessary to use software which is designed in compliance with the standards (GAMP 5, 21 CFR Part 11 etc.) used in the pharmaceutical industry for computerized systems. Apart from this, there is a track and trace infrastructure which consists of different layers, which is regarded by the pharmaceutical industry. The layers of this infrastructure guarantees that track and trace processes produce stable and accurate outcomes. The software which manages the data management of the serialization process is in the track and trace infrastructure in LEVEL 2. This software has to use EPCIS, CBV industry standards to communicate LEVEL 3.

In the following part of our essay, we will try to explain the process of serialization for pharmaceutical cartons in detail step by step.

Trace and track technologies are becoming more and more important for all industries day by day. Through traceability technology, you can assure your product safety against counterfeiting, theft and illegal trade.

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 different algorithm. But the important thing is to prevent the duplicated data when different 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 which 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.

The production lines are managed through ERP and MES softwares in pharmaceutical plants. It is necessary that the work order integration equal to LEVEL 3 with ERP or MES are to be done so that the serialization machine could use the right master data set.

Many cartons which have different geometrical shapes are produced in pharmaceutical medicine lines. The cartons which have different sizes and weight 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.

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