Integrating PAT and robotics to bring pharmaceutical manufacturing to the next level
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Emerging technologies in process control can lead to a quantum leap in process intensification that will help pharmaceutical industries to thrive , even in an increasingly competitive global market . A particularly powerful and compelling application consists of combining factory automation and robotics with process analytical technologies ( PAT ). By implementing such a system , drug manufacturers can become more accurate and agile - satisfying regulatory compliance while ensuring efficiency in their R & D and manufacturing operations . Martin Gadsby , Director at Optimal Industrial Technologies , looks at why robotics and PAT are a match made in heaven on the manufacturing line .
Ensuring high-quality , effective drugs that meet regulatory requirements and customers ’ expectations are challenges that the pharmaceutical and life science sectors constantly need to address by means of robust and comprehensive quality assurance and process control strategies . The digitization and automation of laboratories and drug manufacturing processes can be a powerful ally to these industries , specifically , the cooperation of PAT and robotics .
This establishes a real-time link between process control and process automation , which can be used to promptly implement quality assurance and manufacturing decisions . In this environment , the physical information from sensors and analytical instruments are passed on to a higher-level system for adaptive decision-making , i . e . PAT knowledge management , that communicates with industrial or collaborative robots to act promptly on the basis of the decision taken .
By leveraging real-time testing and dynamic responsive robotic process automation ( RPA ), drug developers and manufacturers can create a truly continuous processing framework that requires minimal intervention and reduces downtime to a minimum . This higher degree of visibility , traceability and responsiveness can lead to both improved and accelerated product development and manufacturing , as well as more effective risk management and associated corrective actions to ensure product quality and compliance .
When looking at innovations in the pharmaceutical field , it is evident that implementing integrated PAT-RPA systems can offer a pathway to success in offering more commercially viable precision medicine .
INTEGRATED PAT-RPA SOLUTIONS ARE ALREADY A REALITY Pharmaceutical filling and preparation of growth media for life science , for instance , is turning into an increasingly robotic process in order to reduce cycle times and increase consistency . When coupled with PAT monitoring quality via spectral analysis , this system can further increase its speed whilst reducing waste .
Researchers in this field have been able to create a high-performance , high-throughput automated robotic workflow for monoclonal antibody ( mAb ) and glycan purification that enabled the implementation of PAT and Quality by Design ( QbD ) approaches . Plate-handling robots are used to collect , prepare , incubate and test liquid samples . The solution reduced cycle times from over 18 hours to only 5.1 This specific innovative system offers a fast and efficient method to produce biotherapeutics for cancer and autoimmune diseases treatment and prevention of xenograft rejection .
PAT AND ROBOTIC ARMS ADDRESS CHALLENGING APPLICATIONS In addition , the use of integrated PAT-RPA systems can be extremely useful in sensitive applications such as those conducted within cleanroom environments . In these situations , rigorous aseptic conditions are a must to produce regulatory compliant sterile products . The use of fully automated manufacturing and quality assurance tools can significantly reduce contamination risk as well as particulate generation , resulting in higher drug quality and lower production of waste and off-spec material .
In particular , recent advances in robotics have allowed articulated robots to meet even the most demanding ISO 3 ( Class 10 ), 2 and 1 cleanroom standards . In addition , these robots can be easily cleaned , are waterproof and can withstand sterilization procedures , such as hydrogen peroxide vapor disinfection .
Conversely , the use of robots and PAT in particularly hazardous conditions can minimize human operator exposure to certain compounds and ingredients . In this way , the combination of real-time testing , process control and process automation can increase operational safety and reduce health risks . More precisely , PAT knowledge managers can guide industrial robots in handling pathogens , highly reactive , corrosive and hazardous substances , conducting chemical reactions in extremely cold or hot environments , as well as ensure the materials are used and processed correctly .