Finnish contract development and manufacturing organisation (CDMO) Fermion has developed and manufactured active pharmaceutical ingredients (APIs) at its FDA-approved facilities since the 1970s.
Last year, investment in its Espoo site increased significantly production capacity of Occupational Exposure Banding (OEB) 5 compounds at the kilo scale. The floor space was expanded from 200m2 to 580m2 and the company saw the installation of a bespoke production unit.
Its design comprises a plant with glass lined vessels along with a Hastelloy C-22 reactor for more demanding synthesis campaigns.
The site at Espoo forms just one small part of Fermion’s highly potent API development and manufacturing capabilities.
The extension of its Hanko commercial production facility, planned for completion in 2018, will provide more production space for OEB4 and OEB5 category APIs.
‘As a manufacturer, safeguarding production staff is of primary concern when developing products and planning for future growth, both in technological advancement and the quality of finished APIs,’ says Jarkko Helminen, Process Development Manager at the Fermion Espoo site.
‘ChargePoint Technology of Liverpool, UK, alongside local partners Thurne Teknik of Stockholm, Sweden, created the solution to meet and maintain our commitment to the safety of our staff during the processing of APIs at our kilo facility in Espoo.’
Despite its obvious benefits to the patient in the final dosage form, the API, along with the intermediates used to synthesise it, can pose significant risks to the health and well-being of workers who handle them in bulk form during manufacture.
Today it is common for CDMOs to operate multipurpose facilities because of the range of products they create and develop. This strategy is evident in many R&D and production facilities but it poses the challenge of handling multiple ingredients without any risk to product quality.
The requirements of reducing both the potential for contamination and the risk of exposing production staff to hazardous chemicals makes the transfer of powders from one process to another a key area of concern for Fermion, and one that is amplified with OEB4 and OEB5 APIs.
As a result, ChargePoint PharmaSafe® containment valves were selected for the transfer of raw ingredients from the dispensing stage to reactors for synthesis.
Split Butterfly Valve (SBV) have been used as an operator safety device within fine chemical and solid dose pharma production for more than 20 years.
They minimise the amount of airborne particle exposure during the transfer of potent powders from one process step to another.
