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#SuccessStory #Patient Kits Packaging Line Mastering Batch Size 1 for Clinical Customers

  • Highly flexible system
  • Personalized patient kits
  • Complete process control and traceability
  • Compact footprint
  • Intelligent data management
  • Transmodul with ID tracking in operation
  • Vision system integrated
  • Cameras for full product inspection

7

Individual Modules

 

1

Batch Count

 

Requirement

Automated Packaging of Personalized Patient Kits: at the Swiss pharmaceutical company F. Hoffmann-La Roche, a Schubert packaging system automatically assembles individual patient kits for clinical trials. Even a single error in packaging can compromise the results of a complex clinical study, making an automated line worthwhile even for small batch sizes. The Schubert system handles batch size one with ease: it assigns medications and placebos to the respective patients and compiles them into fully personalized patient kits.

 

Solution

Maximum Flexibility Through Transmodul Technology. Schubert’s technology is ideal for requirements demanding maximum flexibility, as it combines straightforward mechanics with intelligent software. Thanks to the Transmodul system, processes are optimally decoupled: four cartons can be filled, two cartons erected, and one carton closed simultaneously. A Transmodul can move in a timed sequence along a section of the line (coordinated with the filling process) and then continue moving continuously (coordinated with the pick-and-place operations).

Each Transmodul is equipped with an ID, which makes it easier to organize processes at batch size one. For example, a single patient blister can be placed on a specific Transmodul positioned at a precisely defined location. Process organization and data management work hand in hand: the blisters for a patient are only produced once their positively verified carton has reached the loading station.

 

“For years, we had envisioned fully automating the unpacking of patient kits for our clinical studies. Now, that dream has become a reality.”

Christoph Mettler, Head of Clinical Packaging and Labelling
Hoffmann - La Roche AG
 

 

Packaging individualized patient kits

From the single blister to the finished shipping package, all processes run in a highly compact system consisting of seven individual machines. The system excels in particular by handling batch size 1.

This means that for each patient, a specific quantity of products (active ingredient or placebo) is labeled with their data and packaged into a personalized carton. The data management system not only records which product is in which packaging, but also pre-determines into which carton each product should be placed.

Complete line management

The line management system receives an Excel file containing the patient data via a USB interface. In addition to the patient information, the batch order also includes production data. Once the order starts, system components such as the vision system receive all necessary information.

The line integrates multiple camera systems to check the readability, completeness, and correct placement of labels on blisters and cartons. Sensors additionally verify aspects such as proper carton closure. If the system detects an error, the affected component of the future patient kit (label, blister, carton, etc.) is automatically rejected.