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Equipment Design Innovation to Drive Continuous Manufacturing Adoption?

Olena Gligorich

Hello CM Experts, Community and Network,  

One of the topics that has been of interest to me for quite some time is the equipment design and innovation to facilitate the continuous manufacturing support and adoption. Interestingly, I do not see a lot of articles or publications around this topic. Curious to learn more about the equipment design changes, evolution and innovation, and how it drives adoption. I am keen to hear from all of you so share your insights and any literature references that might be of interest. A couple of themes and questions around this topic outlined below: 

  • What are the equipment design features required to promote continuous manufacturing adoption? 

  • Are there operational efficiencies that needs to be achieved?  

  • What are the automation requirements that need to be introduced to drive adoption?  

  • Beside regulatory requirements, what are the safety requirements, real-time monitoring and quality controls?  

  • Are certain materials being better than others for durability, longevity, performance of equipment in the CM field? As well as sustainability that includes reducing waste and energy consumption? 

  • Are there challenges in retrofitting existing equipment to support continuous manufacturing? Or should certain upgrades be considered to ensure the needs of continuous manufacturing met? 

Parents

  • Dear Olena.

    When considering the implementation of CM for primary pharma, or API it is important to understand that the it is the combining of technology with chemistry that delivers the advantages. It is the increased pressures, increased surface areas, near instant micromixing among other technology advantages that deliver near absolute control of the chemical environment. This effectively optimises the process chemistry without the normal limitations of large batch processing. 

    There are significant compromises when performing this chemistry, in that a reactor is just that, it is not a holding vessel, a evaporator or a liquid/liquid phase separator... The batch vessel is very 'multi purpose'. Having said that, bulk chemical manufacturing is almost never carried out batchwise, it is mostly always dedicated and adopts flow. But its the most efficient way of production. 

    The actual challenge is to give the process chemists the knowledge and reasons for using adopting flow processing, and that normally involves engineers. I personally am a little different, since i have both process chemistry and engineering sides to me in the one person that makes flow development easier. I am aware that here in the UK chemical engineers don't study much chemistry, and chemists do not study much engineering. But the effort needs both disciplines to succeed.

    There needs to be a focus of efficient process 'techno' chemistry - optimisation of chemistry without the limitation of the round bottom flask. Everything else will follow, if there is a desire to carry out API manufacturing at the lowest cost, with minimal waste. 

    With regards to materials and equipment - there is always the push to make systems multi purpose. This is a legacy of batch. We use pressures typically of 100bar, but we have seen API processes that are advantaged at 200bar. We have worked on API processes that, within weeks dissolve or compromise hastelloy c276 with stress corrosion cracking. Now if we want all our systems universally corrosion resistant, all wetted parts will need to be tantalum, kalrez and PTFE, capable of 200bar+. This is unrealistic, so compromises in design need to be used for specific processes. 

    I have every confidence that adoption will continue to grow!

    Best regards

    Ollie

     

  • in reply to Oliver Tames

    Hello Oliver, Thank you for these insights. I captured a few that really stood out in your summary:

    • Combining technology with chemistry provides significant advantages in CM 

    • Highlighting flow processing efficiencies vs batch processing 

    • Importance of both process chemistry and engineering knowledge for successful flow processing  

    • Efficient process chemistry focuses on optimizing chemistry beyond traditional batch methods 

    • Material and equipment design 

Reply
  • in reply to Oliver Tames

    Hello Oliver, Thank you for these insights. I captured a few that really stood out in your summary:

    • Combining technology with chemistry provides significant advantages in CM 

    • Highlighting flow processing efficiencies vs batch processing 

    • Importance of both process chemistry and engineering knowledge for successful flow processing  

    • Efficient process chemistry focuses on optimizing chemistry beyond traditional batch methods 

    • Material and equipment design 

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