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
MYTOS & TWISTER 50
Results
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 reduc ing of waste products
- GMP compliant design with ATEX layout available
Source:
https://www.sympatec.com/en/applications/pharma-jet-milling/