Expansion of the bench scale unit and HPAPI production update
The past 6 months have been a busy time for Fermion. We have successfully launched our newest HPAPI module at our Oulu plant and heard those promising sounds of construction from our bench scale site in Espoo.
Module 10: High containment facilities opened in March 2015.
A peek to the first 6 months at the newest HPAPI module
Module 10 at the Fermion Oulu plant was launched in March 2015, according to the schedule, after all test runs had been completed and authority inspections successfully passed. This module is dedicated for the production of non-cytotoxic HAPIs and products requiring containment levels up to 0,1 µg/m3 can be handled there.
Since its launch, module 10 has produced intermediates and final APIs of three products in the scale of tens of kilograms. Fermion is pleased with the busy start at the module but we also welcome new products – the facilities and the equipment have proved very well fit for HPAPI products, just as planned. As always, Fermion invests in continuous process optimization and flexibility: we have already applied a few small modifications to the equipment in module 10 whenever starting the manufacturing of a new product to ensure that all settings are optimal and meet the specific requirements of each product. In addition, we will add hydrogenation equipment to one of the reactors during this fall.
A number of clients have already visited the module and have been extremely impressed by the high level of automation and the manner in which the high level of containment and usability of the equipment is ensured.
Brand new bench scale unit to be completed by the end of 2015
The autumn of 2015 will bring another addition to Fermion’s capabilities to complement Oulu’s Module 10: the bench scale unit at the Espoo site is currently being upgraded and expanded. The space of the unit will be almost tripled from 200 m2 to 580 m2 and compounds requiring high containment up to 0,2 µg/m3 can be handled in the new facilities. The construction work started in March and completion is planned for December 2015 and everything is on schedule.
Contrary to more traditional bench scale labs, this new unit is designed like a plant and enables efficient and reliable scale-up work utilizing a production-type Honeywell data acquisition system. Three isolators will be installed for dispensing, filtration and multi-use such as drying, milling and homogenization. Split valve technology for charging and high containment Nutsche filters are part of the brand new equipment. As a specialty, a Hastelloy 30-litre reactor with up to 30 bar pressure and +200°C will be part of the equipment repertoire.
The new unit will be opened by the end of 2015 and Fermion welcomes customers to visit the site right after the opening. Stay tuned!