Filter dryer isolators are closed systems with built-in stirrers that can be pressurized and evacuated for multiple production steps. They've been used in the past with open discharge and sampling valves.
For the production of active and highly active pharmaceutical ingredients (API and HAPI), the filter dryers are combined with isolators. The system is used for sampling, discharge, and for harvesting the rest layer in the filter dryer.
Challenge areas to watch when combining filter dryers and isolators:
- Isolator/filter dryer interface
- Transfer to the powder during discharge
- Powder collecting containers
- Separation of collecting containers from isolator
- Environmental conditions (e.g., explosion-proof areas, heat, pressure differences)
- Operator safety around the filter dryer (moving stirrer)
At MBRAUN, we follow international and regulatory norms from our first contact with you to final product, including qualification and validation.
Please contact us if you have questions choosing the right filter dryer isolator system for your specification needs.