High Potent API: can 1 containment system accommodate all this?

Process:

From solid liquid separation to micronized Highly Potent API (CPT = 200ng/m3) all contained in isolators: Filter dryer discharge, Vacuum transport system to 8” ProMill-8 jet mill in a micronization Isolator.

System description:

  • isolator connected to Agitated Nutsche Filter Dryer (ANFD) through flange:
    • top chamber to discharge product from ANFD to isolator
    • bottom chamber for product transfer towards a conical mill or a discharge chute
  • Vacuum Transport System to transfer the product from the ANFD isolator to the buffer vessel installed on top of the micronization isolator
  • ProMill-8 jet mill installed in the micronization isolator. The system includes:
    • manual loading chamber
    • buffer vessel, where product is discharged into jet mill feeder
    • jet mill chamber (with 8” ProMill-8)
    • filter sleeve chamber, where solids/gas separation occurs and process gas is exhausted
    • top pack-off chamber hosts dosing system and inner bag clamp
    • bottom pack-off chamber hosts drum, outside bag and scale
    • exit chamber

Benefits of FPS Solution:

  • No risk of exposure to the operators during the entire process
  • Easy to move the product from ANFD to the jet mill
  • Simple way to reprocess product with Filter Dryer when necessary
  • Removal of large micronization filter sleeve is ergonomic
  • Flexible pack off that accommodates many different drum sizes

Focus on Filter Dryer discharge for High Potent:

1 isolator with 2 chambers.

Inside, a discharge chute fitted with conical mill accommodates 3 processes:  

  • Direct product transfer to buffer vessel (pneumatic transfer)
  • Product through conical mill and transfer buffer vessel (pneumatic)
  • Product through conical mill and packed into a bag for manual charging of buffer vessel

Process description:

The operator opens the internal hatch of filter dryer (through isolator gloves)

The powder is discharged into one of the 2 chutes available:

  • Continuous liner system
  • Conical mill-SBV-container

3 processes can be accommodated:

1) discharge into a continuous liner (up to 10kg bag)

This is used in 2 cases:

  • if filtration and drying is insufficient and product needs to be re-processed by the filter dryer
  • to bypass the VTS for a small quantity and to manually move the product to the jet mill isolator (for manual charging inside the buffer vessel).

Process:

  • discharge the product inside a liner, crimp & cut (1st bag)
  • exit the 1st bag through another continuous liner (side wall), crimp & cut (double bagging)
  • The liner chute available at the bottom of the discharge isolator allows to discharge the product inside a liner and safely remove it and exit the bag from lower chamber

2) discharge into a conical mill

If, after filtration and drying, the product is agglomerated or to achieve a narrower particle size distribution it may be necessary to use a conical mill which is connected to a container through a Split Butterfly Valve

3) discharge into a container (through a SBV).

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