The A – Z of Pharmaceutical Aggregation
An effective, stable, and efficient pharmaceutical track and trace system is only possible with integrated serialization and aggregation processes. According to our observations, the frequent error in projects is the disregard of the pharmaceutical aggregation process. In fact, pharmaceutical track and trace system regulations prepared by all legislators define this process as direct or indirect. However, since it usually starts after the serialization requirement, project teams often overlook it when preparing URS documents. DSCSA and EU-FMD have indirectly defined aggregation for pharmaceutical products. However, many pharmaceutical manufacturers and project teams predicted this necessity and started integration efforts from the first day.
Unfortunately, a serialization project designed without considering aggregation process requirements is very likely to fail or partially succeed. We will try to convey the details and importance of this process in the ongoing sections of our article.
What’s the Meaning of Aggregation in Pharma?
The pharmaceutical industry has already been using tertiary packages (bundle, case, pallet) to facilitate supply chain operations.
This process provides easy access to the serial numbers of all packages within tertiary packages by establishing parent-child relationships. In this way, you can access the serial number of the package and drugs without opening any tertiary package.
Let’s assume that we placed 5 cartons with serial numbers 10, 11, 12, 13, 14 in an empty case. Then, by aggregating these serial numbers, let’s relate these numbers with SSCC and apply SSCC label on the case. Now we can access serial numbers of drugs through SSCC without opening case at any point in supply chain. Pharmaceutical Aggregation establishes a relationship between the SSCC of the tertiary packages and the serial number of all the drugs and packages in the pharmaceutical production process.
Traceability can be defined as tracking the points of a product across the entire supply chain with an electronic registration system. This electronic registration system can only be created by legislators or powerful non-governmental organizations. Because it can only be possible only upon the instruction of authority for all manufacturers to serialize their products and to enter the traceability records of all stakeholders in the market.
The pharmaceutical industry is the only industry in the world where the concepts of product serialization and traceability are completely applied. This industry has been struggling with black-marketeering and counterfeiting for years. Pharma serialization and traceability were successfully implemented in Turkey in 2012 for the first time in the world. This implementation has been an example of accelerating the publication of pharma tracking system regulations of all countries in the world. It is estimated that pharma tracking systems, which are still in their infancy in many countries, will be more important and functional after the current pandemic.
The country with the most successful implementations in serialization and traceability in the world is Turkey without hesitation. In the current situation in Turkey, end-to-end traceability implementations are made for medicines, vaccines, cigarettes, and plant protection products.
Why is Aggregation So Important in the Supply Chain?
In pharmaceutical track and trace processes, you must record every step of serialized drugs in the supply chain. If drugs were to move through the supply chain one by one, it would be an easy operation. But drugs generally move with tertiary packages such as bundles, cases, and pallets among stakeholders. In a supply chain without aggregation, each stakeholder can access serialized data within tertiary packages only through irrational operations. Aggregation is crucial as it provides access to serialization data of drugs within tertiary packages via SSCC. Thereby it enables supply chain operations.
If you are designing a track and trace system for a product sold in high quantities, your process will become chaotic without pharmaceutical aggregation.
How To Create Data While Aggregating – Hierarchical Data
Data generated by establishing a parent-child relationship with each other is hierarchical data. This structure, which we use at many points of our daily lives, forms the basis of aggregation data. In the diagram below, you can see the hierarchical data as pallets, cases, and cartons. We use this data in aggregation operations in the pharmaceutical industry. You can download the sample data for aggregation by clicking on the link.
How is Pharmaceutical Aggregation Implemented? – What You Need To Know
First, check out your production line. You should focus on how you make tertiary packages. We say packages because you may be packing multiple tertiary packages at the same time on your production line. The main problem you need to solve is how to aggregate the serial numbers of the drugs in the tertiary package and how to relate them to the packages.
In the next part of our article, we tried to summarize the aggregation methods. You can use these methods for bundle, case, and pallet.
Many pharmaceutical manufacturers bundle pharmaceutical product to determine the minimum number of sales. To bundle pharmaceutical product, first put them together, then make a package that will keep them together. Transparent film and paper are often used as packaging materials.
The most important point in the aggregation operation of the bundles is this. Whether you make the bundle manually or with a machine, you must implement aggregation after the drugs become bundles. Otherwise, you may corrupt data integrity. You can decode the codes in the bundle with high-resolution cameras at an appropriate point. Furthermore, you can apply the label containing the SSCC manually or automatically. You should reject non-labeled products or unreadable SSCC automatically from the line.FIND YOUR PRODUCT
The use of cases, especially for OTC products, is a very common method. Manufacturers who do not want to invest in equipment and workforce prefer automatic or semi-automatic packing systems. In countries where the workforce is cheap, we encounter operations, where they place drugs in cases by hand.
The significant issue in case aggregation operation is the necessity that serialized codes be read inside the case. It is not the right method to attempt collecting data for pharmaceutical aggregation at the moment when the drug does not physically enter the case.
You can include cameras and illumination to the sorting and pushing mechanisms of semi-automatic and automatic case packer machines. In this way, you can aggregate cases without changing your existing lines. You can add print & apply labeling and camera unit back of your packaging line to make automatic case labeling.
In operations where we fill cases by hand, we implement aggregation with a high-resolution camera and an illumination system that sees the contents of cases. Since the camera system changes place according to the layers in case, we call it a semi-automatic aggregation system.
Bundles or cases are usually stored or transported placing on a pallet. Therefore, while pallets are moving through the supply chain which bundles and cases they are associated with must be aggregated.
The operators usually carry out this operation manually while they place bundles or cases on the pallet. When they reach the targeted number of tertiary packages, the operator manually applies a label generated automatically. Robots can perform this operation on the lines where you manufacture automatically.
VISIOTT is your supplier close by that produces sustainable solutions for track and trace projects in many industries. The VISIOTT team scrutinizes the importance of track and trace projects in all aspects for consumers and producers. Therefore, our team has successfully completed more than 500 traceability turnkey projects since 2009. Today, we implement serialization and aggregation systems designed by VISIOTT brand in track and trace projects around the world.