Spray Dryer integrated in an isolator | FPS

April 13, 2021

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