Pilot scale manufacturing approach for novel low-GWP propellants

Paul Dowdle¹, John Crowder¹, Ian Robinson¹, Mark Hargreaves¹, & Simon Bryan¹

¹Koura, Thornton Science Park, Pool Lane, Ince, CH2 4NU, Chester, UK

Summary

Koura is a global supplier of fluoroproducts, including the pressurised metered dose inhaler propellants Zephex® 134a (P134a) and Zephex® 227ea (P227ea). As part of a transition towards the new generation of low Global Warming Potential (GWP) propellants such as Zephex® 152a (P152a), Koura has installed and qualified a compatible pilot scale manufacturing system at Thornton Science Park, UK. The facility is constructed and operated to consider the risks associated with filling of flammable gases and has already been used to manufacture multiple batches using the new propellants on behalf of several parties. The principles applied within the facility have also been used to define the requirements for larger scale operations at pilot, registration and commercial scale using the new low GWP propellants with planning and in some cases implementation for these facilities at an advanced stage.

Key Message

Formulation manufacture and pMDI filling to cGMP standards using low GWP flammable propellants such as P152a has been demonstrated.  Processes and procedures that mitigate the flammability risk to personnel and facilities have been defined and implemented.