Fermion API Manufacturing Facility Expansion, Hanko, Finland

Fermion API manufacturing facility

Global pharmaceutical substance manufacturer Fermion is expanding its active pharmaceutical ingredients (API) manufacturing plant in Finland to further develop its manufacturing and commercial production capabilities.

The construction on the facility is expected to begin in 2016 and is scheduled for completion in 2018. The expansion will replace the oldest factory production and is expected to take Fermion to a new level in global API and highly potent API (HPAPI) manufacturing to meet the increasing demand.

"The $34m investment in the Hanko facility is the biggest investment made by the company since 1970."

The $34m investment in the Hanko facility is the biggest investment made by the company since 1970 and also adds up a new achievement in the history of the Finnish pharmaceutical industry.

The company aims to build a new facility, which can comply with all the regulatory requirements and support both its current and new business.

Details of Fermion API manufacturing facility expansion

The expansion includes the construction of a new state-of-the-art facility that will add 6,000m² (64,583ft²) of manufacturing space for increasing the production capacity by 50% of the current 300t.

The new facility will not only produce standard but also potent APIs ensuring high quality and delivery reliability of the products. It is expected to produce 100t of HPAPI a year, which will increase the total production of the Hanko facility to more than 400t of API a year.

Equipment installed at Fermion's new and existing API facilities

The investment will ensure that Fermion will be able to supply pharmaceutical ingredients for Orion's current proprietary drugs and also its pipeline products.

The new API manufacturing facility will contain 76m³ of reactor space installed with highly automated systems, controlled material flow, isolators and smart infrastructure.

A reactor space of approximately 25m³ will be dedicated to OEB5 compounds requiring a contaminant level of 0.1µg/m³, while the remaining space will be equipped for the compounds requiring a contaminant level of 1-10µg/m³.

The fully equipped existing facility consists of three production units with total reactor capacities of 240m³, reactors ranging from 1,000l to 6,300l in capacity, fully automated active pharmaceutical ingredients production, a separate micronisation area, dedicated areas for the large-scale manufacture of class IV narcotics and immuno-suppressants and buss loop reactor of 500l for hydrogenations up to 80bar. It also contains on-site incinerators of volatile organix compound (VOC) gases and a biological waste water treatment facility.

The facility is complaint with environment, health and safety (EHS) regulations, with features such as solvent recycling capacity of approximately 8,000t, and frequent monitoring of emissions and effluents in co-operation with local and national authorities.

Marketing commentary

Fermion is a wholly owned subsidiary of Orion Corporation, providing APIs for generic, specialty and branded pharmaceutical companies. It also offers fully integrated contract development and manufacturing services from phase one stage to commercial-scale production.

It is a leading global pharmaceutical substance manufacturer, with headquarters, R&D facility and two manufacturing sites located in Finland.

The company is known for its dynamic capabilities to prioritise and satisfy customer needs and adherence to the current industry regulations to provide a competitive service.