Serialization

Aggregation: Exploring the Pharmaceutical Supply Chain Parent-Child Relationship

The Adents Team Written by The Adents Team
21-Mar-2019

Pharmaceutical companies have spent a lot of time, effort, and money over the past few years preparing for the myriad of serialization laws enacted in many countries around the world. The laws have come in many varieties. 

For example, the US DSCSA has taken a measured approach with increasingly stringent requirements for each supply chain participant, while the EU FMD passed an endpoint authentication law that places the compliance burden primarily on manufacturers and dispensers.  

These topics will be covered in more detail later – but let’s begin with aggregation.

What is Aggregation?

In the serialization world, aggregation is commonly understood as capturing and maintaining parent-child relationships between different packaging levels of product.  The process entails serializing product at the saleable unit level, then associating those units to the next level of the packaging hierarchy (e.g. shipper cases). The shipper cases are also serialized with their own serialized GTINs or SSCC numbers, and these are then associated with pallets. The pallet will typically have a unique SSCC number assigned.

By applying, capturing and associating serial numbers in the packaging hierarchy, supply chain participants are able to infer the contents of a container (i.e. shipper case or pallet) with one scan of a barcode.

Pharmaceutical Serialization and Aggregation: How Is It Done?

Aggregation starts on the packaging lines of manufacturers and contract packagers.  There are many ways to achieve aggregation – typically it will depend on the type of packaging equipment, packaging components (bottles vs. cartons) and level of automation on the line. 

The first step in the process is unit-level serialization. Serialization is accomplished by applying a serial number to a carton or bottle label. This may be done prior to packaging (a.k.a. pre-serialized labels or cartons), but it is most often done at the time of packaging.

The serialized units are then associated with a shipper case. The shipper case label has a unique serial number.  In the US, it is typically a serialized GTIN where the shipper case has a specific GTIN. The unique serial number can also be applied using an SSCC, which is product agnostic.

Once shipper cases are packed and sealed, they are typically placed on pallets. The SNs of the shipper cases are then associated with a pallet SSCC number.

Manual, Semi-manual or Automated Aggregation Methods?

There are many types of packaging lines in operation today: old and new, automated or manual, and everything in between. The method of aggregation will largely depend on the packaging equipment on the line, or conversely, the packaging equipment on the line will be determined in part by the type of aggregation method employed.

Aggregation can be completely automated by utilizing additional camera/optical and material handling equipment. Additional automation brings increased complexity and almost certainly a higher price tag, but the packaging operation requires less FTEs on the line and can run at higher speeds.

For low speed or high-changeover product mix lines (or tighter budgets), manual or semi-manual aggregation methods are better solutions. These typically require an operator to either scan each unit, or scan layers using a fixed camera setup.  Solution providers can help determine the most efficient configuration for your packaging operations.

One quality aspect of packaging that benefits from aggregation is the reconciliation process. Whether it be labels and serial numbers, the process is easier to control when each unit is being associated with a parent object (case or pallet).

Operational Impacts of Multi-Level Aggregation

The process of aggregating products on the packaging lines adds additional complexity from a solution and systems perspective, but it also adds complexity from a procedural standpoint. For many configurations, the accuracy of the aggregation depends on strict adherence to material handling processes on the line. For example, if rejection bins are not managed correctly or dropped/mis-placed bottles are not handled correctly, there may be errors tracking commissioned units into cases.

This complexity continues throughout the post-lot material handling process – both at the manufacturing site and logistics warehouse. Damaged or re-configured pallets need to be tracked to ensure the association of units to cases to pallets is accurate.

While the additional processes can be onerous, there are benefits to be realized with the information aggregation provides. One prime is example is returns management. Manufacturers and wholesale distributors will be able to match returned product with original shipments using serial number data. This will solve two problems: 1) sellers will be assured buyers are returning products they actually bought, and 2) credits will be applied accurately by associating products with original transactions.

Want to learn more? Download our global serialization landscape for pharmaceutical products for a complete overview of the different laws and regulations for serialization and aggregation around the world.

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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