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The QC Sample Split operates as a vital link between aseptic filling and quality control. By automating the sample handling process, it accelerates existing workflows, allowing for earlier integration into the QC process. The system’s design enables seamless operation and can be adapted for various use cases in the QC, laboratory, and repackaging areas, accommodating different product requirements.

Equipment overview

QC Sample Split Automation Overview

Process

At Roche’s Kaiseraugst site in, the QC department receives samples from various filling lines. These include approximately 20 different products in vials ranging from 2-20ml, each distinguished by different flip-off cap colors and diameters. Samples are delivered in three Akylux boxes labeled with a Barcode as follows:

  • Start
  • Middle
  • End

Upon arrival, an employee in the QC department divides the samples according to a predetermined split plan into various boxes, which are then distributed to different laboratories. Depending on the setup, the three initial boxes can be divided into up to 12 different laboratories. Each laboratory may receive a unique box size, ranging from 105x55x43mm to 188x130x97mm.

wide range of different vials, caps and flip-offs

Our innovative system aims to automate the sample splitting process, thereby reducing the workload on employees and enhancing overall efficiency. By eliminating potential human errors, the system significantly improves quality and reduces batch release lead time by up to two days, especially when the sorting equipment is located in the same building as the samples. By placing the sorting step earlier in the process, samples can reach QC laboratories more quickly, leveraging the efficiency difference between a 1-shift QC model and a 5-shift filling facility model.

This system not only streamlines operations but also ensures faster and more reliable sample handling.

Flexibility and ease of use

The QC Sample Split Automation is a cutting-edge robotic solution designed for the future. It delivers high performance in a compact footprint, with a flexible design that allows for seamless expansion and easy cleaning. The intuitive graphical interface makes operation simple and efficient, maximizing productivity.

Fabian Stutz, CEO of Pharmabotix
  • Ease of operation: The equipment can be operated via a state-of-the-art graphical HMI. Wizards guide the operator from the start of the equipment to the start of production.
  • Recipe-Based Operation: All programs are stored as recipes containing data for vials, boxes, grippers, and camera settings. Operators are guided through a simple wizard to start the system quickly.
  • User-Friendly Adjustments: Recipes can be modified or extended by the end-user as needed. To prevent errors, the system performs a plausibility check, ensuring, for example, that too many vials are not assigned to a single box.
  • Minimal Hardware Modifications: Apart from changing the suction gripper (13/20mm cap) using a quick-release coupling, no other hardware modifications are required.
  • Magnetic holders: All adjustable parts are equipped with magnets and can be easily adapted to corresponding box sizes.
  • Efficiency: The system increases the efficiency of the QC process by enabling sorting much closer to the filling process. Batch and recipe data can be directly loaded onto the system controller via barcode scanning, streamlining operations. The system is designed to handle future processing needs, including:
  • Processing tubs
  • Processing syringes
  • Unpacking Akylux boxes into tubs
  • Seamless Integration: The robot is directly connected to the Siemens control of Pharmabotix via the SRCI interface, eliminating the need for manual teaching. All positions are calculated, allowing for recipe adjustments or new creations without programming effort.
  • Integrated Vision Sensor: The gripper’s integrated vision sensor reliably identifies all vial types and flip-off caps, regardless of colour, and determines the pick positions for the Stäubli TX2-60L six-axis robot.
  • Ergonomics: The system is built according to general ergonomic principles. In addition to ensuring appropriate heights for the loading positions and the HMI.
  • Cleaning: Great care was taken to make the system easy to clean. For instance, all stops and holders for Akylux and laboratory boxes are magnetic, allowing for easy removal and significantly simplifying the cleaning process.

Conclusion

The QC Sample Split system is designed for broad applicability and ease of transferability, making it accessible to a wide range of users without the need for extensive customization. Through the use of configurable recipes and continuously adjustable slots for laboratory boxes, the system can easily be adapted to different products and processes. The only adjustment needed is to expand the camera jobs for different cap colors and variants, making it simple to integrate new products. The flexibility of the system is further enhanced by the deployment of the Stäubli Tx2-60L robot, which allows for system expansion and adaptation according to specific customer requirements.

In summary, the QC Sample Split system is designed to be easily transferable to additional users with minimal adjustments, providing a versatile solution that can grow and adapt to meet evolving needs.

2024 ISPE Robotics of the Year Award winning equipment

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