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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? 

  • Dear Olena, 

    Thank you for your great remark. We have covered almost all of your points in several webinars during the last two years. The next is coming up on the USP webinar platform this Thursday about the way to measure equipment effectiveness (OEE) and how to use this benchmark to develop the business case for CM. Please sign up and listen and lets get in contact afterwards. On top, we even have put together a multiple day regulatory ICHQ13 training package which can be also offered to any other CM interested party. If you wish I can walk you through the comprehensive agenda. Lastly, we have modelling and digital twin capabilities available for CM drug substance as well as drug product process development work.    

    Kind regards and hope we can meet at least online any time soon. 

    Richard  

  • 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

     

  • Dear Olena,

    Wish to propose that there is much in the trade secret or emerging intellectual property space that is simply not discussed publicly.  It sometimes takes years for anything to become public.  If it is a trade secret it may never really be publicly known or widely adopted.  As a consultant I am obligated to keep a lot of things private and they will always remain so at the preference of my clients.  

    Also wish to endorse other comments in the thread that what can be discussed is shared in a growing number of forums devoted to continuous manufacturing. 

    Indeed, those of us dedicated to processing always know that the process is material/product specific and the more something can be tailored and specialized to optimize the dictates of the material/product, especially continuous manufacturing, the more efficient the production is. 

    Hope those thoughts help you. 

    Best,

    Howard Stamato

    SSL

    www.stamatosolutions.com

  • in reply to Richard Steiner

    Thank you Richard - I registered and look forward to attending the USP webinar tomorrow. It looks like it will be an engaging discussion. I also appreciate you sharing information on the regulatory training. It will be a pleasure to meet you as well.

  • in reply to Howard Stamato

    Thank you Howard - Great points on the trade secrets and IP space considerations.

  • in reply to Anthony Tantuccio

    Thank you Anthony for sharing this article. 

  • 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