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.
Carton Serialization Methodology
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 without based on GS1 standards. Russia has added a crypto code into its regulations by adhering 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, 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 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 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.
Quality Control For Data Matrix and Human Readable Data
The quality of each Data Matrix code formed during the process of serialization might be calculated numerically through ISO 15415 standards. Whether the pharmaceutical carton will be accepted or not is decided according to the numeric results. The evaluation criteria and its maximums are determined by the regulations of the target market. During the implementation process of serialization, some human readable data (HRD) like Exp Date, Lot etc are added. Whether these data are written right or not must be checked through OCR technique.
A minimum PPM for every code and HRD are needed in order to figure out the right evaluation. That’s why, choosing the right camera is of great importance during the process of pharmaceutical Serialization. When you are determining the speed of your system, the completion time for image processing cycle is the most important factor.
There is a document named DataMatrix Guideline for Quality Control For Data Matrix and GS1 organization. You can find more detailed information in this source.
Rigid and Flexible Mechanism
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.
VISIOTT will provide you professional service support and hardware for Pharmaceutical Serialization which we mentioned for the subjects above.