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An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
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Using PAT to accelerate the transition to continuous API manufacturing.

Francisca F Gouveia1,2, Jesper P Rahbek3, Asmus R Mortensen3

  • 14Tune Engineering Ltd, Av. António Augusto Aguiar, 108, 1050-019, Lisbon, Portugal. ff@4tuneengineering.com.

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Summary
This summary is machine-generated.

Transitioning to continuous manufacturing offers significant benefits. This study identifies near-infrared (NIR) spectroscopy as an effective Process Analytical Technology (PAT) for real-time monitoring and control in continuous API production.

Keywords:
Continuous processesIn-line monitoringProcess developmentSpectroscopies

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Area of Science:

  • Chemical Engineering
  • Process Chemistry
  • Analytical Chemistry

Background:

  • Continuous manufacturing offers advantages over batch processing, including cost reduction, waste minimization, and improved safety.
  • Integrating Process Analytical Technology (PAT) within a Quality-by-Design (QbD) framework enhances process understanding and control.
  • Developing robust analytical methods is crucial for monitoring and controlling continuous reactions effectively.

Purpose of the Study:

  • To establish a roadmap for selecting optimal technologies to accelerate continuous process development.
  • To develop analytical methods for real-time monitoring and control of continuous full-scale reactions.
  • To evaluate the suitability of various spectroscopic techniques for monitoring a critical intermediate in API synthesis.

Main Methods:

  • Investigated in-line Raman, FT-infrared (FT-IR), and near-infrared (NIR) spectroscopy for real-time monitoring.
  • Focused on the synthesis of 1-bromo-2-iodobenzene, involving an unstable diazonium salt intermediate.
  • Developed a quantitative method using theoretical concentrations due to challenges in off-line sampling.

Main Results:

  • All investigated spectroscopic methods accurately captured critical information on the intermediate's accumulation.
  • Near-infrared (NIR) spectroscopy demonstrated satisfactory performance, ease of installation, and scalability.
  • NIR spectroscopy exhibited stability under adverse process conditions, making it suitable for full-scale production.

Conclusions:

  • In-line NIR spectroscopy was selected for monitoring continuous full-scale production due to its performance and robustness.
  • The developed analytical system accelerated continuous process design and improved manufacturing understanding.
  • Real-time monitoring ensures optimal yield and minimizes by-products in continuous reactor effluent.