Feature Article

"First, do no harm" applies to manufacturers of healthcare products as well as doctors. It is the manufacturer’s duty to minimise risk for the patient and to ensure product quality and performance.

1. Easier qualification and validation. Comprehensive validation testing (also called performance qualification or PQ) is easier to control and perform with a robotic system.
2. Consistent quality assurance. It is essential that medical and pharmaceutical products achieve the quality required by their intended use. Once PQ has been performed, robots are better able than human operators to perform repetitive tasks in a precise, consistent manner without interruption. Precise control of the manufacturing process is maintained for the lifetime of the robotic system. A specific process will consistently produce a product that meets its predetermined specifications and quality attributes.
3. Elimination of product or operator contamination. Robotic systems minimise the need for manual handling, thereby reducing the risk of operator contamination. Robotic processing within specifically designed laminar airflow cabinets, typically within cleanrooms, help reduce the risk of contamination of the product during manufacture. Robotic processing can occur in pressurised environments to protect the product from the operator or external environment, or, conversely, to protect the operator and wider environment from the product itself.
4. Improved hygiene. Robotic systems designed for use in CGMP environments are manufactured to withstand sterilisation. This facilitates the establishment of baseline cleanliness levels that are required as part of a comprehensive sanitation and hygiene programme.
5. Reduced cross contamination. Precisely choreographed robotic arm processing within the laminar airflow reduces the risk of any process cross contamination between batches. This is particularly important with autologous and allogeneic cell therapies.
6. Elimination of human error. Human error is a prime cause of problems within manufacturing facilities—mislabelled containers are but one example. Robotic systems, by definition, are not prone to human error. Process validation is performed at each stage and labware, intermediates and products are automatically tracked.
7. Greater efficiency. Robots can work continuously with minimal to no supervision.
8. Automatic scalability. Process automation leads to improved productivity without having to revisit fundamentals each time production requirements change. By teaching an automated system to mimic a manual technique, a validated process can be deployed and scaled up to suit requirements.
9. Effective security procedures. System control software integrated with the robotics allows tailored levels of security for operators and supervisors. Based on the Windows security model, the user interface provides controlled access to critical process parameters within the system and helps prevent unauthorised access or process variation.
10. Better yield. By replacing the variability of multiple operators with consistent and reproducible operations, robotic systems enable increased productivity without compromising quality.

This article was written by Bob Turner of Quadcom Ltd for Stäubli, a developer of robotic systems headquartered in Switzerland with facilities across Europe, North and South America and Asia/Pacific. More than 16,000 Stäubli robots have been installed worldwide.