CONTROL & AUTOMATION A MATCH MADE IN HEAVEN
OPTIMAL INDUSTRIAL TECHNOLOGIES LTD
Integrating PAT and robotics to bring pharmaceutical manufacturing to the next level
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 .
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 .
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 . Within this framework , the pharmaceutical product composition determines the processes that are required , and the associated factory robots and machines carry out the necessary operations .
INTERCONNECTED PHARMA 4.0 The connection of PAT and RPA also offers a starting point to integrate data from systemwide physical , operational , and robotic assets to drive not only manufacturing and quality assurance activities , but also maintenance , inventory tracking and many other variables and KPIs across an entire plant . This is , in essence , the level of interconnectedness that Industry 4.0 and Smart Manufacturing aim at .
Nonetheless , the synchronicity of PAT and RPA not only helps to build a Pharma 4.0 factory , but also it improves the practical everyday operation of pharmaceutical manufacturing systems by streamlining operations , lowering production costs and cycle times whilst increasing throughput and performance . Hence , the large-scale adoption of these technologies is not a matter of ‘ if ’ but ‘ when ’.
When committed to implement a successful integrated PAT-RPA , it is important for manufacturers to rely on skilled and knowledgeable specialists that have extensive experience in process automation , robotics and PAT . They can design and build bespoke solutions that address specific plant requirements in the most efficient manner , smooth the process before and after installation as well as ensure that the automated line is running at its optimal performance level . In this way , industries in the pharmaceutical and life science sectors can be sure to benefit from the most suitable solution for their specific applications .
For further information , please visit www . optimal-tech . co . uk
32 PECM Issue 49