Innopharma - SmartX – Automated DOE in Twinscrew Wet Granulation Research Paper

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The trend towards continuous manufacturing in the pharmaceutical industry continues to grow for a multitude of reasons which include, a small footprint, ability to scale out rather than scale up as the duration of a manufacturing campaign is simply extended to meet commercial needs, less material waste associated with process deviations and the ability to rapidly perform Design of experiments (DOE). Continuous manufacturing has the potential to accelerate drug production and improve global supply issues and has gained strong support from regulatory bodies such as the FDA.

Automation is first and centre in implementing any continuous process / manufacturing line – (Dahlgren et al,. 2019) and is built on a foundation of in-debt process knowledge and understanding. DOE is one of the first steps in the process development cycle to acquire more thorough understanding of the design space and in defining the key relationships,

Innopharma research labs have been funded by EI (Enterprise Ireland) to develop new methods of processing to further Industry 5.0. The paper showcases some of the benefits/advantages of smart automation when applied to DOE leading to more efficient experimentation and a cost/labour in modern facilities, and what is possible with new technologies. In this research they demonstrating better methods and techniques in the understanding that those who don’t adapt are left behind.

In brief, implementing automation and advanced control enables the user to swiftly and precisely execute DOEs, rapidly generate valuable data, which in turn accelerates the learning curve leading to save on time, money (materials) and lead to better processes overall.

Instruments Used:

• SmartX Process Digitalisation & Automation Platform
• Bradbender DDSR20 Gravimetric Loss-in-weight Feeder
• Eyecon2 Particle Analyser
• ThermoFisher Pharma 11 Twin-Screw Extruder
• Leadfluid BT301L

Material Used:

• lactose monohydrate
• microcrystalline cellulose
• polyvinylpyrrolidone

Please find link below to download the paper - 

Implementing an Automated DOE in Twin Screw Wet Granulation | Innopharma Technology