Control of Particle Size of Pharma Jet Milling process

Article by Nguyễn Vũ Hoàng Duy at 06.03.2022
Control of Particle Size of Pharma Jet Milling process

Control of Particle Size of Pharma Jet Milling process

Without suitable online analysis the pharmaceutical jet milling process would have to be interrupted on a regular basis in order to analyze the grinding progress in the lab using individual, manually removed samples.

Specifications of the Pharma Industry

  • High demands for product quality of active ingredients and excipients and their safe handling and production
  • Real‐time quality and production control of critical parameters throughout the production process to ensure final product quality
  • Guidelines for the manufacture and sale of food, drug products and active pharmaceutical products overseen by regulatory agencies
  • US authority for health and human services with worldwide impact

Reasons for on‐line Particle Sizing control of Pharmaceutical Jet Milling process

  • Particle size distribution is an important quality criterion for active pharmaceuticals ingredients (APIs) and excipients
  • Request for best possible design of production means
  • Safe production as APIs are potentially harmful for operators
  • Safe therapeutic use as particle size distributions of APIs and excipients affect bioavailability and drug effects

Sympatec instruments recommended



Variations of Milling Conditions

Real‐time Adjustment of Milling Conditions

The benefits

  • Better understanding and control of manufacturing process according to FDA’s PAT initiative
  • Timely in‐process measurements of critical quality attributes (i.e. particle size
  • Closing the control loop, ensuring of final product quality
  • Fast and user independent quality control
  • Process optimisation by reducing of waste products
  • GMP compliant design with ATEX layout available