Spray Dryer integrated in an isolator

How to safely discharge a Spray Dryer and mill the potent API?

Process:

Feed slurry into the Spray Dryer, collect the potent dry powder, micronize if necessary, weight and dispense (for pilot application: max 5 kg)

What are the issues?

  • Staff comes in and out of the lab very frequently:
    • Each time they lose 3 minutes: gowning & de-gowning
    • Staff is tired of this repetitive process
    • High cost of disposable gowns (12 gowns/day/person)
  • A ladder must be used to feed the product into the spray dryer
    • Risks of fall
  • Potent dry powder can be spilled when feeding the jet mill
    • Increases the risk of exposure
  • A split butter valve is needed at Spray Dryer discharge:
    • Difficult to clean
  • Some product must be transferred to another area for micronization:
    • Risk of exposure during High Potent API transfer
    • Micronization process is dusty and difficult to contain

FPS custom solution:

Custom isolator with 1 inlet airlock, 1 chamber to host the pilot spray dryer (+ feeder & jet mill when needed) & 1 chamber for discharge.

Inside the main chamber a custom vacuum system with separation cyclone & HEPA filter collects the spilled potent api.

Benefits:

  • No need for PPE: isolator provides the containment
    • staff comes can get in and out of the lab freely
    • Cost saving: 500 gowns/week (for the lab)
    • Time saving: 25 hours/week (for the lab)
  • Height of the isolator is easily adjusted with motorized feet
    • All staff can work comfortably regardless of size
    • Product loading in spray dryer is much easier
  • Discharge of Spray Dryer is done in an isolator chamber:
    • No need to use a split butter valve: cost saving
    • Difficult cleaning of SBV is avoided
  • Custom vacuum system to clean spilled powder around jet mill:
    • Designed for high potent powder
    • Safe change of HEPA filter avoids exposure
  • Micronization done inside the isolator:
    • Dusty process is fully contained
    • No transfer, no risk of exposure
    • Cleaning inside the isolator avoids risk of exposure

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