Packaging line efficiently realises batch sizes of one for clinical studies

Highly flexible line
Personalised patient kits
Absolute control safety
Compact machine layout

Requirements

Intelligent data management ensures maximum flexibility and quality

Fully automatic packing of personalised patient kits: A Schubert packaging line for the Swiss pharmaceutical company F. Hoffmann-La Roche automatically packs individual patient kits for clinical studies.

A mistake during packing can make the results of a laborious clinical study worthless; a packaging line is a worthwhile investment even when small batch sizes are produced. For F. Hoffmann-La Roche, a Schubert packaging line manages batch sizes of 1: It assigns drugs and placebos to individual patients and packs them together into personalised patient kits.

Solution

Hand in hand: Process integration and data management

Schubert TLM technology is ideal when it comes to meeting this maximum flexibility requirement because it consistently combines simple mechanics with intelligent software. Thanks to the Transmodul, all processes are optimally decoupled. It can load four boxes, erect two and close one, all at the same time. A Transmodul can move along a section of its route in a cycle (coordinated with the loading process) and then drive on continuously (coordinated with the pick-and-place process). Each Transmodul has an ID code. This makes it easier to organise processes at the level of batch sizes of one. Example: The individual patient blister is placed on a particular Transmodul, which is situated in a precisely determinable location. Process integration and data management work hand in hand. For instance, a patient’s blisters are only retrieved (produced) if that patient’s box passes the test and reaches the loading station.

For years we have had the vision of packing the patient kits for our clinical studies automatically. That dream is now being fulfilled.

Christoph Mettler

Head of Clinical Packaging and Labeling at F. Hoffmann-la Roche Ag, Switzerland

Technical Details

Flexible automated solution packs individualised patient kits

From the individual blister to the finished shipment package with the individual patient kits, all the processes are carried out in a highly compact line consisting of seven sub-machines. The line scores points because it is able to handle the challenge presented by batch sizes of one, i.e.: For each patient, a certain number of products (active substance or placebo) must be marked with the patient’s data and packed into a box, which also needs to be personalised. The data management system not only keeps a record of which pack contains a particular product, it also manages which box each product needs to be packed into.

Complete line management

The line management system receives an Excel file containing the patient data via a USB interface. As well as the patient data, the production data (e.g. patient kit layout type) is also stored in the batch job. When the job starts, line components such as the Vision system receive all the necessary data.

The line incorporates several camera systems in order to ensure that the labels on the blisters and boxes are readable, complete and correctly placed. There are also conventional sensors to check for things like the boxes being closed properly. If the system reports an error, the affected component of the patient kit (label, blister, box etc.) is rejected.