Hierarchical Data: Defining the Cases in Aggregation Serialization

We all know how important drug serialization is in the pharma or the life sciences industry. The benefits are manifold starting from improving inventory visibility to protecting consumers from counterfeit drugs. But is that enough to protect the interest of the consumers? Some of the few recurring issues that the pharma industry faces include transparent data exchange, longer turnaround time during FDA audit, delayed verification processes, negative returns and more.

So, is there a single sure-shot solution to address all the above-mentioned issues? Experts advise-Aggregation. We have said enough about the aggregation serialization in our previous article ‘Why is Pharma Aggregation the Future of Traceability? An Inside Story’ and ‘Why you Need to Take Unit-level, Lot-level and Package-level Identifiers More Seriously!’, but the need to discuss about it yet again is important here because Hierarchical data can be discussed only in a context, which needs to be set here.

So, let’s start with what we already know.

What is Aggregation?

The process of locating a medicine, which includes building a parent-child relationship between certain unique identifier codes is known as aggregation. For instance, a medicine bottle (child) and its packaging box (parent). Although not a legal requirement in the FDA regulations, it is extremely useful for visibility purposes within a supply chain.

Aggregation also allows each of the participants to receive the information captured by the previous participant in the supply chain and then supplement the database with his own information. The Data aggregates are then stored in a database and then passed along to the next partner along the pharma supply chain. This data can be requested at any time and comprises the primary, secondary and tertiary packaging information.

Hierarchical Data- Deep dive into aggregation

The data formed and captured by parent-child relationship is known as hierarchical data. The hierarchical data is different for pallets, cases, and cartons. This data, once stored, helps stakeholders in checking the visibility of the product and its origins during crucial traceability processes such as the VRS.  

How are the hierarchical aggregation implemented?

Before starting hierarchical aggregation, it is important to focus on how you make tertiary packaging because most likely you would be packing multiple tertiary packages at the same time in the production line. The main problem you need to solve is how to aggregate the serial numbers on the drugs to the package itself.

-Bundles

Medicines are packed in bundles so that pharma participants can determine the sale numbers. However, they are also a practice when it comes to hierarchical aggregation. To bundle, it is important to place a group of medicines together and then package them with a transparent film or paper to keep them together. The aggregation implementation should be done only when the bundles are formed and not before that. Because otherwise, the data integrity would be corrupted. The codes on the bundle can easily be decoded with the help of high-resolution bundles at any given point. It is important to mention here that unlabelled or unreadable SSCC should be rejected outrightly.

-For Cases

Cases are packages which already have serialized units of medicine. Now while performing aggregation on cases, opening and capturing the individual data on the medicines is not possible; that's because the cases are sealed. So, the next best thing to do is to capture the data when the cases are being made and pass on the information to the next level of packagers. The serialized data on the individual medicines should be linked to the labelling on the case comprising them.

There are some stakeholders who prefer to do this manually because that is cheaper than deploying semi-automatic or automatic equipment. The thumb rule is the same in this case, but the only thing is recording needs to be done manually.

-For Pallet

Bundles and Cases are usually transported on a pallet. In cases of manual intervention, the serial numbers on bundles or cases should be aggregated with the serial number on the pallet manually. So, when the pallet reaches the final destination, screening through the pallet serial number will provide details about individual units in the bundle.

How is the hierarchical data captured?

Aggregation for each shipment is often shared with the trading partners downstream of the pharma supply chain. This is either done directly or through a government website, depending on the requirements of the local regulation. The recipients of the shipping container can use the aggregation data to know details about the unit-level serial numbers and where are they located, without even opening the cases. The information can also be shared with a central regulatory database, which can be accessed by either the regulatory bodies or the stakeholders down the pharma supply chain. To be specific, the information that is shared includes unit-to-bundle, bundle-to-case, case-to-pallet or even other less common levels.

Now, the companies will be using the aggregation data for regulatory purposes using “inference”. This means they will infer unit-level serial numbers shown in the aggregation data received to be representing the contents of the shipping containers that are being handled. The use of the inference eliminates the need to open the containers to confirm which unit-level serial numbers are present.

Accuracy of aggregation data and technology

Aggregation is often being done by machines, owing to the volumes of bundles that are being handled each day. So, this means that the accuracy of the data captured often goes unverified. But there’s a way to ensure that the data captured and passed on is uncompromised- by deploying the best technologies in the industry such as multiscanners, driven by AR-enabled software and insta-verification technology. In an industry dominated by single scanners taking most of the screening workload, the mentioned equipment can do the work accurately in half the time taken by conventional scanners.

The aggregation data is so much in sync at the minuscule level that one error in one case can lead to a cascading effect on another case, so one must ensure that the technology that is being deployed has been designed to perfection. Needless to say, aggregation-triggered problems will prove to be extremely complex and costly to resolve. It would require documenting the error in details and confirming that the error was an innocent one.

But imagine if that happened, the entire pallet would be considered as a “suspect” and might be a case of negative verification, ultimately leading to unnecessary disposal or expiration, costing the chain millions of dollars.

Data storage is another important part of the aggregation. The platform which has to store the data should be easily navigable and prompt enough to throw back results within seconds. A traceability suite can do the job. Once captured, the data is stored in a safe and secured centralized repository which can provide quick information whenever required by either the health authorities or the pharma stakeholders.

Capturing hierarchical or aggregation data is a complicated process because that would require storing data at different levels of packaging, matching identifiers and verifying their origins.

Last words

Serialization, hierarchical aggregation and verification go hand in hand. As complicated as they are, it is important to identify ways to streamline them to reduce the turnover time and also save money in the process. It must also be remembered that complicated processes require expensive procedures, but investing in advanced equipment is a one-time process that can neutralize both the complexity and the expense across a period of time.