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

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

Aggregation Camera Record the Codes on Pharma Bottles Barcoded Tote for Bottles of Diagnostic Reagent 
360-degree Aggregation Camera Captures Bottle Codes at the Machine Infeed  Serialization Case Label with 2D Code and Barcodes
As the carton progresses to the case packer, it is packaged in a case with other cartons to form a “parent,” case. (3) The cartons’ recorded serial numbers are linked to the case in which they are loaded. At the discharge of the case packer, case labels printed with codes that contain information about the case contents are applied. This parent-child dataset can then be traced to the pallet load. Case label codes are scanned before the case is placed on the pallet. Once the pallet is complete, another label is printed with a code for the pallet as the parent to the cases.

Integrating Aggregation into Packaging Lines

Tracking the product from the time it is placed in its primary package (bottle, vial, tube, jar, pouch, etc.) to its final placement on a pallet at the end of the packaging line requires integrating inspection and tracking equipment with the packaging machinery at each step in the packaging process. Manufacturers should select an OEM serialization system supplier who has experience working with equipment providers to streamline the integration of the tracking system with the packaging machine.

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.

Case packers and palletizers share with aggregation and serialization processes a certain amount of repetition, making them well-suited for robotics automation. Robots are impervious to illness, repetitive motion injuries, and boredom. They won’t lose concentration performing the same process and can maintain high production speeds with complete accuracy for hours. Robots offer flexibility in both product handling and programming new inspection or tracking criteria, allowing the system to evolve with the needs of the manufacturer. All of these factors work to reduce costs.
Overhead Serialization Camera Inspection Camera Reading Bottom of Case Load
Overhead Serialization Camera Bottom Code Serialization Camera

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.

Serialization System Print and Apply Labeler Inspection Camera for Serialized Case Label
Serialization System Labeler Bottom Code Serialization Camera
Labeled Pallet LoadThis strategy of identifying each aggregate can also be applied to the palletizing process. Case labels are scanned as they enter the robotic pallet cell and recorded by the serialization system PC. Robotic pallet systems offer greater flexibility for integrating serialization than conventional palletizers. Robots can be programmed to determine, via sensors, the location of the case label, verify it to a barcode scanner, then position it on the pallet so that the case label can be seen. The final pallet can also be labeled using QR codes, barcodes or readable codes to fully verify the contents of the pallet. Labeled pallets complete the aggregation and serialization 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.

References
1) Godfrey, Bryant M. “Ready or Not, Here It Comes! The Drug Supply Chain Security Act Requirements Are Almost Fully Upon Us. Are You Prepared?” Food and Drug Law Institute, Nov. /Dec. 2019. https://www.fdli.org/2020/01/ready-or-not-here-it-comes-the-drug-supply-chain-security-act-requirements-are-almost-fully-upon-us-are-you-prepared/#:~:text=In%20November%202013%2C%20Congress%20enacted,throughout%20the%20pharmaceutical%20distribution%20supply Accessed 9/14/2020.
2) Ibid.
3) “Aggregation in the Pharma Industry: Product Traceability Beyond Boundaries.” https://www.wipotec-ocs.com/us/aggregation-pharma/ Accessed 9/22/2020.
4) Ibid.
 
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