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A PAT-based qualification of pharmaceutical excipients produced by batch or continuous processing.

A Hertrampf1, H Müller2, J C Menezes3

  • 1Quality Operations, Laboratory for Liquid Products, Merck Serono, Frankfurter Str. 250, 64293 Darmstadt, Germany; Institute for Biotechnology and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049-001 Lisbon, Portugal.

Journal of Pharmaceutical and Biomedical Analysis
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PubMed
Summary

Comparing batch and continuous manufacturing of sodium carbonate (anhydrous), this study found continuous processes can improve attribute consistency. Enhanced process understanding and control strategies ensure similar product quality across different manufacturing versions.

Keywords:
Multivariate data analysisPharmaceutical engineeringPharmaceutical excipientsProcess analytical technologyQuality control strategySupplier qualification

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Materials Science

Background:

  • Pharmaceutical excipients significantly impact drug product quality, safety, efficacy, and manufacturability.
  • Process changes during a product lifecycle, from minor improvements to major site transfers, can affect critical quality attributes.
  • Enhanced process understanding is crucial for risk management and maintaining product quality, aligning with Quality by Design principles.

Purpose of the Study:

  • To compare the quality of anhydrous sodium carbonate produced via batch versus continuous manufacturing processes.
  • To evaluate the influence of different continuous processing equipment (dryer and crystallizer types) on product quality attributes.
  • To determine if continuous processes can achieve product quality comparable to traditional batch processing.

Main Methods:

  • Investigated anhydrous sodium carbonate quality from three processing alternatives: batch, continuous line 1, and continuous line 2.
  • Analyzed chemical and physical attributes using Raman spectroscopy, laser diffraction, and X-ray powder diffraction.
  • Applied Principal Component Analysis (PCA) for multivariate analysis of spectral data to identify subtle process-related differences.

Main Results:

  • Continuous processing improved the consistency of certain attributes, such as particle size distribution, compared to batch processing.
  • Specific chemical and physical attributes were affected differently by the continuous processing lines.
  • Principal Component Analysis effectively extracted relevant information from complex spectral data, highlighting process-specific variations.

Conclusions:

  • While continuous manufacturing impacts certain attributes, it offers potential for improved consistency in others.
  • Increased process and product knowledge gained through advanced analytical techniques enables better control strategies.
  • Distinct process versions, including continuous manufacturing, can yield similar product quality when supported by robust understanding and control.