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Related Experiment Videos

End-point detection in a wet granulation process.

P Holm1, T Schaefer, C Larsen

  • 1Pharmaceutical Development, H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark. ph@lundbeck.com

Pharmaceutical Development and Technology
|June 22, 2001
PubMed
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Power consumption effectively monitors granule growth in high shear mixers, enabling precise liquid addition control. This method, however, is sensitive to mixer parameters but not ingredient ratios.

Area of Science:

  • Pharmaceutical Engineering
  • Process Control
  • Materials Science

Background:

  • High shear granulation is a critical unit operation in pharmaceutical manufacturing.
  • Accurate control of the granulation end-point is essential for consistent granule properties.
  • Power consumption monitoring offers a potential in-line method for process control.

Purpose of the Study:

  • To evaluate the feasibility of using power consumption measurements for granulation end-point control in a high shear mixer.
  • To investigate the influence of various process parameters on the correlation between power consumption and granule growth.

Main Methods:

  • Experiments were conducted in a 25-L high shear mixer.
  • A fractional factorial experimental design was employed to study the effects of impeller design, speed, liquid addition rate, binder type, and lactose:starch ratio.

Related Experiment Videos

  • Power consumption and mean granule size were measured during the liquid addition phase.

    • Main Results:

    • A general linear correlation was observed between power consumption and mean granule size.
    • This correlation was significantly influenced by impeller design, impeller speed, and binder type.
    • Power consumption-based end-point control was not sensitive to variations in the lactose:starch ratio.
    • The level detection method for stopping liquid addition at a predetermined power consumption level was found to be feasible.

    Conclusions:

    • Power consumption can be utilized for granulation end-point control, particularly via the level detection method.
    • The peak detection method for end-point control was not universally applicable due to inconsistent peak identification.
    • Process optimization requires careful consideration of mixer design and operating parameters for reliable power consumption-based control.