What is pharmaceutical aggregation?
In the context of drug serialization, pharmaceutical aggregation is typically viewed as the capture and maintenance of parent-child relationships between various product packaging layers. The procedure involves serializing the product at the level of the saleable unit, and then linking those units to the subsequent level of the packaging hierarchy (e.g. shipper cases). Additionally serialized with their own serialized GTINs or SSCCs, the shipper cases are then linked to pallets. Usually, the pallet will receive a special SSCC number.
Pharmaceutical aggregation is also defined as the association of uniquely serialized medications with higher packaging levels. The products that are unit-serialized arrive in a bigger container (case, bundle, or pallet). Each bottle or carton in a bundle has its own serial number, but the bundle also has a top label with a distinctive serial number on it. Pharma aggregation, to put it simply, is the method of assigning container-unique IDs a hierarchical connection.
This article will explore the purpose behind aggregation and its benefits for pharmaceutical companies as well as how it is done. It will be of great help to those who are looking for new ways to upgrade the serialization systems they are working with. Not only that, but it might soon become a requirement as serialization regulations continue to change and evolve in the coming years, even though it currently remains optional.
The purpose behind pharmaceutical aggregation
As with anything that is not mandatory (at least according to the EU’s Falsified Medicines Directive), our first instinct is usually to question why we should even do it in the first place. This is especially true in the case of things that will require time, effort, and/or money. If there are no regulations at this time that demand aggregation within your company’s serialization systems, then why even bother with it?
From pallet to case to individual pack-level products, aggregation creates parent-child linkages. That makes it possible to scan a case’s or pallet’s exterior code to learn what is within; this eliminates the requirement to open the case in order to obtain the serial number of each individual pack-level product. The main purpose behind pharmaceutical aggregation, then, is convenience and efficiency. Although it is easy to hand wave away the importance of just how many benefits this can bring to your business, hence why we have prepared the next section.
The benefits of pharmaceutical aggregation
Let us now dive a bit deeper into exactly how aggregation can help your business. There are many benefits to be had through introducing this upgrade to your serialization systems. We will now explore each one individually.
Pharmaceutical aggregation significantly boosts efficiency, as was already mentioned. This is due to the fact that scanning the higher-tier package code provides access to all relevant and crucial information about the medications. Since there is no need to open each container to scan each individual package, this saves a ton of time. If a pallet was damaged in transit, either completely or partially, it could be decommissioned in bulk. Aggregation will make removing the broken goods from the system much simpler. And this is just one example. Any kind of bulk scanning and other actions is greatly simplified through an aggregated system.
The use of traceability and aggregation technologies results in significant cost reductions for proactive pharmaceutical businesses. The pharma industry loses an average of 4.5% of its potential revenue annually due to supply chain inefficiencies alone, and aggregation improves supply chain efficiency. When a company is adaptable enough to upgrade its serialization systems above that of its competitors, they are likely to get a competitive advantage in the modern pharma marketplace.
Easy access to information
Pharmaceutical aggregation creates a more effective, reliable, and secure system, which provides all the required data and makes it simpler to trace any medications throughout the supply chain. We have talked about before how good information management can make or break serialization systems. Aggregation is just one more way that you can make access to information about your medications simpler and more efficient.
Simpler reporting and verification
At one or more points along the supply chain, reporting and product verification can be made easier through the optimization of supply chain activities driven by aggregation. The required information can be quickly retrieved by scanning the barcode of the parent packages, which results in considerable time and resource savings.
Painless product recalls/returns
The management of the entire inventory return process is made simpler by aggregation technology. Additionally, it enables pharmaceutical companies to recall only certain product units, as opposed to an unnecessarily large amount. On top of that, using serial number information, producers and wholesalers will be able to compare returned goods with initial shipments. This will address two issues:
- By linking products to original transactions, credits will be applied correctly.
- Sellers will be guaranteed that customers are returning items they truly purchased.
How is aggregation done?
Pharmaceutical aggregation begins in manufacturing and packaging lines. Aggregation can be accomplished in a variety of ways, depending on the packaging equipment used, the packaging materials used (such as bottles versus cartons), and the level of automation on the line. Serialization at the unit level is the initial step in the procedure. A carton or bottle label is serialized by adding a serial number to it. This can be done in advance of packaging (also known as pre-serialized labels or cartons), although it’s usually done at that time.
The shipper case is then connected to the serialized units. There is a distinct serial number on the shipper case label. If we are talking about the US, the shipper case has a unique GTIN which is normally serialized. A product-neutral SSCC can likewise be used to apply the unique serial number. Shipper cases are normally put on pallets once they have been sealed and packed. Then, a pallet SSCC number is linked to the SNs of the shipper cases.
Which pharmaceutical aggregation method a company uses will largely depend on its existing packaging equipment (or sometimes vice versa).
By using additional camera/optical and material handling technology, aggregation can be fully automated. Although the packaging operation requires fewer FTEs on the line and may operate at faster speeds, additional automation increases complexity and almost likely raises the cost.
Manual or semi-manual aggregation techniques are preferable for product mix lines with low speed or high turnover (or for budgets that are more constrained). In most cases, an operator is needed to either scan every unit individually or to scan layers with a fixed camera system. Solution providers can assist in choosing the configuration that will optimize your packaging operations.
Other ways to grow and improve your pharmaceutical business
This guide should have given you an in-depth understanding of pharmaceutical aggregation. Although it is not yet mandated, aggregating your serialization systems comes highly recommended because of the above-mentioned benefits. However, maybe you have decided that it is simply not for you or that you do not have the resources to invest in it at this time. On the other hand, maybe you have already implemented it. Either way, you might be looking for other ways to optimize your serialization systems and grow your company.
For this purpose, two of our services might come in very useful. Nubinno Assessment and Nubinno Accelerator can help you determine which aspects of your setup or approach can be improved and help you come up with a clear goal along with actionable steps to achieve it. Whether or not you decide to dive into aggregation, you deserve some help with your business!