Giuseppe Menin: Traditionally, batch chemistry has been the primary production method in the pharmaceutical industry. While this method may be well-suited for small to medium-scale production, it also comes with clear limitations. In your experience, what are the primary downsides of this method?
Dirk Kirschneck: In batch production, all chemical ingredients are combined in a single vessel, known as a batch reactor, where they react for a set period under controlled conditions. In typical batch processes, mass and heat transfer distances are relatively long, meaning molecular conditions may change over time. Conditions can also vary from one batch to another, which may lead to inconsistencies in product quality. Another limitation of batch chemistry is that, once production has started, modifying a batch can be challenging and time consuming. For example, adding ingredients may lead to uneven molecular concentrations while reaching an even distribution can take a long time.
Giuseppe Menin: What are the main differences between flow chemistry and batch production?
Dirk Kirschneck: Unlike batch production, flow chemistry is a continuous manufacturing process that constantly pumps ingredients through a reactor. In this process, the reaction occurs continuously as the molecules flow. The advantage of this method is that it allows precise control over reaction parameters such as temperature, mixing, and residence time, often leading to improved product consistency. As mass and heat transfer distances are very small in comparison with batch production, molecular conditions are more consistent.
In addition, flow chemistry allows manufacturers to react faster to potential defects and rectify them or amend recipes according to changing product requirements.
Giuseppe Menin: It’s not uncommon for pharmaceutical manufacturing processes to occur under hazardous conditions like explosive atmospheres. Exposure to toxic chemicals is another common risk in pharmaceutical applications. How can flow chemistry help address these risks?
Dirk Kirschneck: In these environments, maintaining stable molecular conditions is critical to preventing potential exothermic reactions. Toxic reactions can be processed more safely in separate compartments. Flow chemistry addresses these risks by enabling constant accurate control over reaction parameters while ensuring the process is safely enclosed.
Giuseppe Menin: Accelerating the production process is key to gaining competitiveness in today’s fast-paced pharmaceutical industry. A shorter time-to-market also enables companies to benefit from product patents for longer. How can flow chemistry help achieve these goals?
Dirk Kirschneck: Flow chemistry enables manufacturers to maximize efficiency and reduce the time-to-market, eliminating multiple steps associated with batch production. These steps include filling the reactor, bringing it to the desired environmental conditions, cooling it after production, emptying it, and, finally, cleaning. In addition, drugs may need to undergo several processes, moving from one vessel to another, before they are ready to hit the market.
Flow chemistry shortens the production cycle while reducing the equipment footprint, as the entire process occurs within the same plant. The containerized fume hood concept developed by Microinnova is a testament to this approach.
Giuseppe Menin: Many pharmaceutical manufacturers today strive for more flexible and agile manufacturing. Product changeovers and customizations are becoming the norm, driven by industry trends such as personalized medicine. How can standardization and modular production help take flow chemistry to the next level?
Dirk Kirschneck: Traditionally, flow chemistry plants have been custom made, but the growing popularity of the module type package (MTP) concept now enables the development of standardized modules that end users can assemble according to their needs. The trend toward standardization applies to R&D laboratories and manufacturing facilities.
This modular approach is transforming product development. Traditionally, product batches were almost entirely developed by chemists in the lab and then passed on to chemical engineers, who had minimal input into the process. In other words, it was a rigid, one-way process with little room for flexibility.
Modular flow chemistry now transforms plants into interactive tools, moving from a sequential approach to a parallel approach. Both chemists and chemical engineers can engage with the process from an early stage, optimizing plant design and production according to different product specifications.
Giuseppe Menin: How are companies like Microinnova putting MTP into action?
Dirk Kirschneck: One perfect example is the FlowKiloLab plant concept that enables end users to assemble their plants by swapping standardized modules according to their needs.
The ability to move quickly from R&D to production offers a competitive edge for pharmaceutical companies, enabling them to go to market faster and benefit from patents longer.
Giuseppe Menin: Reduced engineering complexity is one core benefit of MTP-led flow chemistry. What’s your experience in this area?
Dirk Kirschneck: Standardization means that pharmaceutical companies no longer need specialized automation engineers to set plants up. Chemical technicians without specific competences or specialized training can easily plug and unplug modules according to their needs.
Giuseppe Menin: And what about interoperability?
Dirk Kirschneck: Interoperability is another core advantage of modularity. In the past, the largest automation companies were effectively in control of the market, meaning plant equipment was only compatible with other hardware and software from the same vendor – a situation known as “vendor lock-in”. MTP now enables end users to integrate modules from different suppliers into their plants. This vendor-agnostic setup increases competitiveness and drives costs down.
Giuseppe Menin: Microinnova has successfully implemented MTP in its plant modules. How has zenon from COPA-DATA helped?
Dirk Kirschneck: The vendor-agnostic zenon process orchestration layer (POL) from COPA-DATA has been instrumental to Microinnova’s successful implementation of the MTP concept. This interoperability enables end users to integrate modules from different vendors within the same plant. COPA-DATA's exceptional technical support team provided invaluable guidance to Microinnova, introducing us to the world of MTP, clarifying its advantages, and assisting us in seamlessly integrating its functionalities into our modules.
Giuseppe Menin: What does the future hold for MTP in flow chemistry applications?
Dirk Kirschneck: The CFRT conference earlier this year demonstrated that demand for modular flow chemistry is growing across the pharmaceutical world, including some of the largest pharmaceutical companies. The wide scale adoption of MTP across the industry will lead to greater innovation, better products and shorter production cycles.
Further information: Learn how to go modular.