Oulu site
Fermion’s manufacturing site in Oulu comprises ten manufacturing modules for intermediates and APIs, distillery, maintenance, separate final handling with micronization area, warehouses, QC laboratory and administrative functions. The site has also a cryogenic condensation plant for VOC treatment. The facility’s focus is on highly potent small volume APIs, however, two modules also produce APIs with batch sizes of several hundreds of kilos. Concentration on HPAPIs starts already at the weighing area, which is equipped with a glove box. Out of 10 modules, two modules can handle OEB4 classified APIs and three modules can handle OEB5 classified APIs including cytotoxic compounds and steroids. The micronization area is equipped with state-of-the-art small scale mills designed specifically for APIs for dry powder inhaler drug delivery systems. The micronization area is capable of handling OEB5 classified APIs. Finally, packaging technology of continuous liners is used for OEB4 and OEB5 APIs. Over 100 employees of Fermion work at the Oulu site. See more information about API contract development and manufacturing services.
HPAPI manufacturing at Oulu
Oulu facility in a nutshell:
- Regularly inspected by USFDA and FIMEA (EMA)
- 10 production modules with a total of 75 m3capacity
- Reactor sizes from 60 l to 6300 l
- Batch sizes from <2 kg to >500 kg
- Dedicated suites for cytotoxic compounds
- Three fully automated HPAPI modules for OEB5 (0,1 - 1 µg/m3) classified APIs with reactors of 250 l, 400 l and 600l
- Reactor charging isolators and filter dryer isolators
Separate final handling department with micronization area capable of handling OEB5 level substances