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Kevin O’Neill of the Irish Examiner asked international industry experts at PM Group for their view on the rapidly evolving world of manufacturing.
Across the Life Sciences Sector, traditional operations are embracing an explosion of new technologies that are changing the way manufacturing facilities work. These range from autonomous robotics and cobots (robots that interact with people), to single-use and digital process technologies, that facilitate automated production with automatic product release. Many of these technologies are receiving significant development and adoption under Industry 4.0 initiatives.
“The Factory of the Future is no longer a concept. It is being designed right now. It will include new technologies adapted to provide the flexibility, quality and speed to market that new drug manufacturing requires,” said Andy Rayner, Chief Technical Officer (CTO), PM Group.
New drug developments such as Cell and Gene Therapies and other new classes of medicines, are driving the need to reduce the opportunities for environmental cross contamination during the complex, often manually intensive, product development life cycle. An important part of that challenge is how to adapt facilities to suit smaller, more numerous processes. One obvious solution is robotics but these too pose innovation challenges.
From fetchers to carriers to samplers, robots have already been identified as a cost efficient solution to reducing contamination risk. With small adaptations, robots used in other industries, can be effective in carrying out procedures such as environmental sampling. The benefit is that they can work on a 24/7 basis and can free up staff for more valuable work.
There are still however problems to be solved. Key challenges include how the robot communicates with other equipment, handles unexpected circumstances and accesses different parts of the factory requiring different levels of cleanliness. It is also important to realise that what the robot interacts with may need to change. What is easy for a human to use may not be easy for a robot.
Automation is central to the success of the Factory of the Future. Over decades significant investments have been made in equipment that can’t currently communicate with one another. In the near future if drug manufacturers are to avoid costly replacements, the industry needs to find a way for equipment from different suppliers to talk to one another seamlessly. This is often referred to as ‘Plug & Play’ and is well on its way to becoming a reality.
The BioPhorum Operations Group’s (BPOG) ‘Plug & Play’ initiative has recently completed software testing as proof of concept. Expectations are high and the next stage is in-factory testing on equipment after which fast progress is anticipated.
Another approach to make plants more flexible and to cut down on cleaning and sterilising between products is to adopt disposable (single-use) systems. Once used they can be disposed of and new systems used. The impact for drug manufacturers is to reduce water usage, lower equipment costs and critically reduce turnaround times.
Many such single-use systems have traditionally been designed as bespoke unique assemblies of components. For the past number of years there has been steady adoption of standardisation across the industry reducing the need for customisation. The new focus for standardisation innovations is fine tuning to create even more efficient processes. A key initiative in this area is SDD™ or Standard Disposables Design. Endorsed by industry and suppliers, this global innovation is helping engineers to design facilities faster, reduce space and costly inventory.
Professional bodies like the ISPE and BioPhorum are collaborating on producing technology roadmaps to that explain how to incorporate new technologies into the designs of factories of the future. They draw on the input from suppliers, researchers, universities and other industries.
According to Andy Rayner, CTO, PM Group, “There’s a huge willingness in manufacturing to explore and adopt new technologies. We’re currently working with the BioPhorum, ISPE, UCD, NIBRT, SFI, Novartis and major industry suppliers like Lonza, Rockwell and Siemens to make these innovations a reality. Without this kind of close collaboration, the ‘Factory of the Future’ would still be in its infancy.”
Read the more about this in the Irish Examiner.