White Paper: Packaging Lines to Meet Pharmaceutical Aggregation and Serialization Requirements

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Introduction

Designed primarily as a response to the increase of counterfeit pharmaceuticals, the Drug Supply Chain Security Act (DSCSA) became law in 2013. (1) The DSCSA requires pharmaceutical manufacturers to show the complete life cycle of the drugs they distribute, from the manufacturing process through the end-of-line packaging. Implementing an aggregated and serialized system in the cartoning, case packing, and palletizing processes can present a number of challenges to pharmaceutical manufacturers, so selecting a qualified packaging machinery supplier to work with the serialization system supplier is vital. While mandates for serialized packaging lines have been in place since November 2018, unit level traceability including aggregation throughout the whole supply chain will be required by November. 2023 (2).

Aggregation Systems for Pharma Manufacturing

Simply put, aggregation allows pharmaceutical manufacturers to trace their products from primary packaging to palletizing using the parent-child principle. The serialization code is printed on the intended unit of sale, such as a carton. The code printer may be integrated within the cartoner or on the discharge of the cartoner. The coded unit of sale is referred to as the “child.” (2).

Products

Monoblock Fillers/Cappers

Cartoners

Case Packers

Assembly and Kit Packaging

TaskMate Robotic Systems(R)

Pallet Cells/Depalletizers

Serialization Systems Integration

Turnkey Machine Integration

Integrating Aggregation into Packaging Lines

The equipment itself should also be considered carefully. Automated packaging machinery is better suited than manual packaging processes to handle the production speeds needed to factor in the time required to record the aggregation codes without diminishing overall production rates. As mentioned, automatic cartoners can be equipped with vision inspection or code printing and reading equipment to facilitate the aggregation process.

Robotic End-to-End Serialized Packaging Lines

Robotic systems can be used in an end-to-end packaging line to help track the first product in, all the way to the finished pallet, ensuring integrity throughout the production process. For example, a packaging line for pharmaceutical bottles begins as each filled and closed bottle is marked with a unique serial number, which may be printed on the label or on the bottle. Cameras record the code as each bottle (or carton, tube, etc.) enters the machine but prior to its collation into the required pack pattern. The codes are stored in the serialization system PC to be accessed as needed by the serialization equipment.

Robotic case packers for aggregation and serialization applications incorporate EOAT that uses a unique suction cup with an integrated vacuum sensor for each product in the pack pattern, allowing the EOAT to verify that it has picked the full pack pattern. Camera systems can also take a picture of the loaded case from above and compare it to a picture of a correctly loaded pattern stored in the PC to verify that all bottles have made it into the case. Alternately, cameras placed below the case load can verify the presence of all the products prior to case loading. A failsafe case packer design ensures that cases with complete patterns are tagged “compliant.” Incomplete cases are not tagged, causing them to be automatically rejected at the case packer discharge.

Compliant cases are labeled with a code that provides information about the contents of the case. The label may include a barcode, a QR code, a human-readable code, or a combination of all three. By tracking each serial number in the pack pattern and applying that information to a unique case, the manufacturer can know at all times exactly where each bottle, carton or tube is in the packaging process.

Conclusion

By implementing robotic packaging machinery with OEM aggregation and serialization systems, pharmaceutical manufacturers can secure their supply line from counterfeiting and meet current and future federal requirements. The investment in integrated equipment provides a streamlined process that can be reconfigured for future applications.