How to best micronize a dusty product and be ready for POTENT APIs?

Issues:

• Particle size reduction down to low micron is needed
• Operators must be protected because product is very dusty
• Large campaigns with expensive product: highest productivity is needed
• High Potent apis will be added in the future

“High Potent Ready” solution:

• Air-tight separation cyclone with WIP to contain dust
• Modular micronization equipment for easy integration in an isolator later
  • 8” jet mill (ProMill-8) with gravimetric feeder
  • Automated system with control manifold
  • Exhaust process gas fan

Custom solution details:

Gravimetric feeder

• The feeder and the weighting scale technical parts are isolated in a different compartment
• A silicone bellows isolates the feeder and its scale from the attached components
• This configuration makes future integration in an isolator easy

Micronization system type ProMill-8:

• Final design (nozzles) and parameters (gas pressure and volume) fine-tuned by FPS micronization experts after micronization technical tests.

Separation cyclone for gas/solid separation:

• inspection door with inflatable gasket for quick inspection, filter replacement and maintenance
• the filtering bag (antistatic FDA approved PE) is octopus type to reduce powder loss
• 1 pneumatic cylinder for automatic filter de-clogging
• WIP with spray balls for top part and custom sprinklers for the separation cyclone cone
• Drainage connection at the separation cyclone outlet

Automated control manifold & control system

• The PLC is connected to a central HMI and controls all working sequences including:
  • Feed Gas Pressure setting
  • Grinding Gas Pressure setting
  • Feeder flow rate setting
  • Process gas selection (Air/Nitrogen)
• Ethernet connection for data transfer & remote support
• CFR 21 compliant, OPC UA protocol

Exhaust process gas fan

• multi filtration to assure exhausted process gas is ok to go into the atmosphere
• controlled suction fan assures proper pressure balance into the cyclone filter.
• Intelligent fan: if the operator changes the grinding pressure (e.g. from 6 to 9barg), the system detects the pressure variation inside the separation cyclone and the fan adjusts its speed to maintain the pressure inside the separation cyclone