FONKO facility is located in the Jababeka Industrial Estate, Cikarang, Indonesia. The facility is newly completed and was GMP certified by Indonesian authority in 2014. It is designed with the aim of satisfying GMP requirements of the regulated markets, such as TGA and EMA.
The facility currently has a sterile manufacturing line capable of handling 5 cc to 50 cc, with freeze drying capability. The total line net annual capacity is 4 million vials which could be increased to 8 million by one additional filling line.
The filling line is equipped with C-RABS configuration, to ensure the aseptic filling operation of highly potent APIs. The filling line is also capable to dose using either rotary piston or precision peristaltic system. The connected external washing system ensures the decontamination of resulting products prior to packaging.
A freeze dryer is also connected to the filling line through the Automatic Loading and Unloading System with Row by Row mechanism. Together with an isolator system to handle dispensing and mixing operation, the facility is safe to handle material up to OEB4.
The facility is also equipped with a leak tight air handling unit, with BIBO filters to ensure safety of the workers and minimize effect to the environment, as well as a pretreatment and decontamination plant to ensure destruction of toxic substances in the effluent prior to reaching the main waste water treatment facility.