The greatest source of contamination in any clean room are the humans who work there. Historically this has been controlled by a mixture of guidelines, best practices and regulations. Applied together these guidelines and practices manage and prevent human contamination in the pharmaceutical clean room.
But, what happens if a human is no longer present? How do we define, manage and monitor clean rooms when no humans are there? Do we need new guidelines? Do we need monitoring? What should we control?
These are some of the complex questions the Fill-Finish Robotics workstream are working together to resolve. The team are looking at how robotic technology in the clean room could redefine aseptic practice and are trying to suggest what guidance is needed when the filling operation is performed by robotic technology with no human intervention.
The Fill Finish Robotics Workstream have been together for six months and have started their journey by gaining an understanding of current industry approaches when using robotics in the filling unit step, through intercompany collaboration exercises, which included benchmarking surveys and group discussions about the challenges created by replacing human intervention with robotic operation.
The end result of the collaboration will be a series of best practice papers for the use of robots in the fill finish area. The workstream are planning to publish a series of user experience articles to provide practical solutions to the challenges presented by robotic technologies in pharmaceutical filling operations. The series of publications will aim to address many aspects of robotic technology adoption from the challenges of environmental monitoring and compliance with cGMP standards for robotic installations to guidance on the selection, installation and operation of suitable robotic technology to allow users to gain optimum benefit from robotic operations.