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

 

 

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