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  1. Home
  2. Pat For Monitoring The State Of Control In Continuous Manufacturing Of Solid Oral Dosage Forms.
  1. Home
  2. Pat For Monitoring The State Of Control In Continuous Manufacturing Of Solid Oral Dosage Forms.

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PAT for monitoring the state of control in continuous manufacturing of solid oral dosage forms.

Nathaly A Movilla-Meza1, Dhavalkumar S Patel1, Rafael Méndez2

  • 1Department of Chemistry, University of Puerto Rico at Mayaguez, PO Box 9000, Mayaguez, Puerto Rico, 00681, USA.

Analytical and Bioanalytical Chemistry
|July 21, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Process analytical technology (PAT) ensures pharmaceutical manufacturing control. Near-infrared spectroscopy monitors drug concentration in continuous manufacturing, improving product quality and process reliability.

Keywords:
Continuous manufacturing (CM)PharmaceuticalProcess analytical technology (PAT)SamplingState of controlVariographic analysis

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology
  • Spectroscopy

Background:

  • Process analytical technology (PAT) is crucial for maintaining control in pharmaceutical manufacturing.
  • Continuous manufacturing offers advantages but requires robust monitoring.
  • Near-infrared spectroscopy (NIRS) is a key PAT tool for real-time analysis.

Purpose of the Study:

  • To review studies on PAT implementation in continuous pharmaceutical manufacturing.
  • To evaluate the performance of NIRS for drug concentration monitoring.
  • To highlight methods for improving PAT effectiveness and process understanding.

Main Methods:

  • Review of continuous manufacturing studies (up to 120 hours).
  • Application of near-infrared spectroscopy for drug concentration determination.
  • Validation of analytical methods (accuracy, precision, linearity, robustness).
  • Use of residence time distribution and variographic analysis.
  • Main Results:

    • NIRS effectively monitors drug concentration and product specifications.
    • Repeatability studies are vital for method performance.
    • Real-time monitoring is feasible from various sampling locations.
    • PAT and modeling enable detection and diversion of non-conforming material.

    Conclusions:

    • PAT, particularly NIRS, enhances continuous manufacturing control and reliability.
    • Variographic analysis distinguishes process variability from errors.
    • Improved process understanding and product quality are achieved through PAT implementation.