Continuous Manufacturing Case Study: Efficiency Concept for Injectables Boosts Manufacturing Efficiency and Reduces Quality Costs
The main aim of the project was the generation of a fundamental boost in efficiency of a manufacturing plant for injectables of a global player of European pharmaceuticals.
Continuous formulation plants enable complete mixing within minutes instead of hours which reduces the reactor volumes by a factor of more than 100. Additionally, this leads to an increase in quality, since the batch process did not lead to a product within specification limits on the first attempt. The batch process had to be repeatedly tested and corrected until the product fit specification, resulting in high quality costs. The continuous solution enables quality control by PAT tools.
Debottlenecking of Chemical Processes by Continuous Manufacturing: Capacity Increase by 50% and Doubled Yield
In the past, this customer of Microinnova had produced the same fine chemical product in four batch vessels. Microinnova developed a continuous process for fine chemical products (Batch-to-Conti). This process was scaled up to manufacturing by designing a continuous plant, using 2 of the 4 existing vessels. The redesigned plant enables an increase of the production volume by 50 % and a doubling of the yield. The manpower previously needed for production was reduced by 90 % after the plant had been automated and switched form manual operation to supervision of the automated manufacturing.
Capacity Boost by Debottlenecking of Batch to Continuous Processing
Space economy is a typical issue for debottlenecking projects. Since a continuous approach reduces mass and heat transfer distances up to a factor of 100, these solutions can easily be integrated into an existing batch environment. A number of different strategies can reduce or replace batch processing times. For example, a batch processing step can be translated into a continuous plant skid.
In some cases the mixing operation or even the reaction itself can be executed while filling the reactor. Reagents, even hazardous ones, can be synthesized in situ. Large savings can be achieved in the field of acid-base-reactions, since they are characterized by a strong heat release. These kinds of processes can reduce residence times from hours to minutes, since they are limited by the heat exchange which can easily be controlled in a continuous device. Mobility of skids enables flexible use in connection with different plants. Optimizing mass and heat transfer is an important factor in reducing the costs per kilogram, leading to increased competitiveness.
- Minimal intervention with maximum effect
- Process simplified – first exothermic batch step switched to continuous
- Production volume doubled
- Cut-down energy costs
- Investment costs were about 1/10 of conventional plant costs!
Learn how we developed and improved chemical processes using flow chemistry technology.
Continuous manufacturing offers an interesting toolbox for the process intensification of API manufacturing processes.
Improving safety by generating hazardous substances in-situ for immediate consumption.