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)
Process:
To filter Highly Potent API, dry the product and dispense it to containers (for pilot production).
Process steps:
What are the issues?
Benefits of FPS Solution:
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:
“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.”