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Updated: Aug 28, 2025
05:21
A Scalable Balz-Schiemann Reaction Protocol in a Continuous Flow Reactor
Published on: February 10, 2023
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Automatic system dynamics characterization of a pharmaceutical continuous production line.
Morgane Jelsch1, Yves Roggo1, Ahmad Mohamad1
1Novartis Pharma AG, Continuous Manufacturing (CM) Unit, CH-4002 Basel, Switzerland.
Summary
This study investigated a Good Manufacturing Practice (GMP) continuous wet granulation line for pharmaceutical production. The research developed an automated method to calculate residence time distribution (RTD) for real-time process monitoring and diversion of out-of-specification materials.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Process Analytical Technology
Background:
- Continuous Manufacturing (CM) is an emerging paradigm in pharmaceutical production.
- Traditional batch manufacturing poses challenges in process control and efficiency.
- Implementing CM requires a deep understanding of system dynamics.
Purpose of the Study:
- To assess the system dynamics of a GMP continuous wet granulation line.
- To define optimal control and material diversion strategies for CM.
- To develop an automated method for Residence Time Distribution (RTD) calculation.
Main Methods:
- Investigated a GMP continuous wet granulation line including dosing, blending, granulation, drying, sieving, and tableting.
- Performed step tests in API concentration to characterize process flow and dynamics.
- Utilized Near Infrared (NIR) probes for real-time API content monitoring.
- Developed an automated RTD computation method using process data.
Main Results:
- Characterized the process flow and dynamics of the continuous wet granulation line.
- Demonstrated the impact of process parameter variations on final product quality.
- Successfully developed and validated an automated RTD computation method.
- Established RTD as a process fingerprint for monitoring system dynamics.
Conclusions:
- Automated RTD calculation enables enhanced monitoring of system dynamics in continuous manufacturing.
- RTD analysis is crucial for defining effective control strategies and diverting out-of-specification materials.
- This approach supports the implementation of robust and efficient continuous pharmaceutical production.
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