A new multipurpose High Potent API facility needed a containment solution for pilot production. It already owned a few pieces of process equipment. To have those integrated in an isolator could be tricky.
Here is a summary of the issues they faced and the solutions implemented by FPS (2 mn read)
To filter Highly Potent API, dry the product and dispense it to containers (for pilot production).
- perform filtration on HPAPI with Glass filters (10 and 30 liters)
- move the resulting wet cake to the 2nd drying process (dedicated tray dryer)
- final dispensing into small containers
What are the issues?
- Glass filters download is manual: operator is exposed to potent api
- Tray dryer loading/unloading is also manual: same issue
- The motor of the glass filter agitator is difficult to clean and critical for maintenance
- Maintenance activities for tray dryer and vacuum pump expose staff to potent API
Benefits of FPS Solution:
- No risk of exposure for the operators
- Flexibility: system can also be used as a stand-alone dispensing isolator
- Safety: all maintenance activities are done in safe area (not potent atmosphere)
Description of FPS custom solution:
A hard-wall multi-chamber Isolator including a chamber for filtration, a chamber for drying and a chamber for dispensing. In addition, the isolator offers a pre-chamber for material inlet. This adds a valuable functionality: the same isolator can also be used as a “stand alone” unit for dispensing activities and for the preparation of product to be loaded into reactors.
Custom solution highlights:
- a special feature lowers/raises the bottom of the filter automatically to collect the powder: no heavy lifting, no risk of dropping the product
- custom designed agitator shaft allows motor and gear reduction to be located in technical area of the isolator:
- avoids exposure to potent compound (and lengthy cleaning)
- allows maintenance staff to operate in safe conditions
- FPS custom tray dryer, specifically designed for operating in isolators
- ergonomic loading/unloading of trays
- easy cleaning of dryer internal part
- all technical part of tray dryer is outside the isolator in technical are
- vacuum pump and transmitters are protected by special design HEPA filters
- all filters feature safe change (from inside the isolator)
"Glass filters have been used instead of steel ones for their transparency, which allows the customer to better follow the filtration activities. Moreover, with particular condensers it is possible to collect the evaporated parts of the solvent too. This material also allows the processing of products sensitive to contamination and the use of even particularly aggressive solvents," explains Fausto Castellana, Project Manager at FPS. "The real challenge for us was to build the containment system ‘around’ the delicate filtering system. The filters used are 30l and 10l, about 1.60m high. After a careful ergonomic study and the creation of a detailed mock-up, we defined the most comfortable and efficient configuration with the customer."