Op 6 facility is an EMEA and FDA approved low volume, multiproduct, high containment organic synthesis plant. Commissioned in 1998, Op 6 consists of 5 equipment trains with 25 reactors with a total volume of 5.6m3 varying from 16 L to 630 L and has dispensing areas that contain seven glove boxes. Within the current production processes at the facility, batch size ranges from 160g to 10kg, illustrating the facility’s range of scale.
The Op 6 building is currently used in the manufacture of high potency and cytotoxic intermediates and finished APIs for parenteral grade oncology products (trains 100 - 800). Pfizer has recently added a new, modular designed state of the art kilogram plant (train 1000). This unit is used to manufacture a parenteral grade prostaglandin used in the treatment of Glaucoma. The unit is highly flexible modularly designed unit, with each 80l reactor module housed in a fully accessible fume-hood. The unit is ideal for the manufacture of developmental or clinical trial materials.
The building is designed to handle materials with OELs less than 1 µg/m3. This is achieved by containment at source through the use of charging isolators, discharging glove boxes and continuous liner technology.
The building is fully automated, with recipe capability, through a Delta V (train 1000) and ADVANT systems (trains 100 to 800). This includes Operator Interface Terminals on the production floor. Heating/cooling of vessels is fully automated and the single fluid Dowtherm™ heating/cooling system operates from -15°C to +90°C. There is also one cryogenic reactor that can reach temperatures of -140°C (train 300).
The building has its own dedicated HVAC system which maintains the air flow rates and pressure differentials throughout the building. The building is supported by 2 adjoining fully automated tank farms controlled from the Ops 6 building. Low endotoxin purified water is supplied to the building from a dedicated generation system located in an adjoining building. Op 6 has a dedicated development laboratory that is used for In-Process Testing.
