By Geir Rune Flåten, Chief Solutions Officer
For more than 15 years PAT has been a well-reputed and promising approach to faster, better and more integrated manufacturing processes in pharma. The promises and visions associated with PAT have a lot in common with megatrends like Industry 4.0 and Internet of Things … in other buzzwords digital transformation. While these new trends have placed themselves firmly on the management agenda, PAT have not achieved the same attention at the management level. Time is definitely now to change this as PAT is very much an enabler for digital transformation in the production and development departments.
Leader or laggard
Companies that embraced PAT years ago are ahead of the game, while companies that are just embracing PAT (in the shape of digital transformation) run the risk of falling further behind. The good news is that more mature technology (hardware as well as software) makes it easier for newcomers to get in the game, and the opening to get PAT on the corporate agenda enables fast-tracking of your PAT capability to bring you to the next level.
Adopting PAT strategies can seem daunting as it is vigorously multidisciplinary in nature. It has to do with software, sensors, instruments, manufacturing and development, in addition to the underlying chemical and physical transformations in your processes. PAT demands different competencies, different departments and maybe skill sets currently not available in your company.
– I claim that only 5 years back a PAT project often ended up as a development project while today [choosing the right application] a PAT project is all about implementation, taking down the project risk and saving you from a number of avoidable pitfalls and delays.
Avoid the pitfalls
To me it seems quite evident that the starting point must be to build on experiences made by others. Seeking advice and guidance from competent vendors and advisers can allow you to fast-track your implementation of PAT. The good news is that the PAT tools are continuously getting better, simpler and more robust lowering the threshold for implementation. I claim that only 5 years back a PAT project often ended up as a development project while today [choosing the right application] a PAT project is all about implementation, taking down the project risk and saving you from a number of avoidable pitfalls and delays.
Whether your PAT project become an implementation project depends very much on the planning phase. Choosing the tools and technologies that scale-up and can integrate into your existing infrastructure is a must. Next, you should also consider the future direction of the PAT strategy; to be future-proof requires that you choose a PAT system which supports a range of different data source types for instance. And do not under-estimate the need for early results to ensure that the benefit of your project is recognized. Understand the problem, choose methods and decide for the precision levels needed.
Unlock the value
If you choose a research and development approach to your first PAT project chances are it will be a slow and costly project, where you will have to wait for results, and you may even be “trapped” with one vendor and not be able to scale.
By leveraging the experiences and approaches from vendors who has the scars to show, you hit the ground running with the first PAT project creating a success for you to build on. On a technology level PAT is not that complicated – unless you decide to re-invent the wheel… Seek advice from partners who already have the knowledge to provide a robust control environment and secure documentation, compliance and scalability. It is all about unlocking the value from using PAT in a future proof corporate style.
Start small and think big!
Join our webinar on how to unclock the value of PAT where Geir Rune will discuss the different recipes for implementing PAT and how to assess and fast-track your PAT maturity.
The webinar will be featured at the IFPAC Virtual Summit on September 1-2 or you can join the webinar for free on September 16. Register now >>
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