Helsinn Advanced Synthesis (HAS), located in Biasca, Switzerland, is the chemical manufacturing business unit of the Helsinn Group. To meet the demand for anticancer molecules HAS will open a new cytotoxic facility in 2013. The facility will be dedicated to cytotoxic compounds that require safe product handling in a contained area for operator, environment and product protection.
PSL worked closely with Helsinn to develop suitable solutions for its cytotoxic facility and is providing a suite of high containment systems, including contained agitated nutsche filter dryers, charging gloveboxes with slurry vessels and a clinicaltrial isolator.
Helsinn's cytotoxic plant comprises a small scale GMP area for the production of reduced quantities of cytotoxic active pharmaceutical ingredients (APIs) for clinical and registration purposes. PSL recently installed the state-of-the-art clinical trial isolator into this small scale GMP area. Numerous operations will be processed inside this high containment isolator with a required operator exposure level (OEL) of less than 50ng/m3 in 8 hours TWA.
The clinical trial facilities present a total synthesis solution for manufacturing and handling cytotoxic compounds on a small scale. The isolator allows the following operations to be performed in one unit in a completely contained environment:
- Transfer and reactor charging
- Reaction in glass reactor
- Hydrogenation
- Filtration
- Drying
- Discharging
- Dispensing, packing and transfer
The clinical trial isolator consists of several in-line synthesis processes including reaction or hydrogenation within a glass reactor of 20L, Buchner filtration and drying within PSL’s CakeStand Tray Dryer. This unique vacuum tray dryer overcomes the inherent difficulties with traditional vacuum drying ovens: through its direct tray heating, the CakeStand performs proven heat uniformity up to a maximum temperature variation of 1°C. The tray dryer integrated within the Clinical Trial Isolator has four heated shelves, pioneering pivot door and is contained in a PSL isolator ensuring high containment during transfer of the cytotoxic compounds.
Clinical trial isolator and contained CakeStand tray dryer
The full synthesis containment system has HMI/PLC control, washing and clean-in-place capabilities with an OEL of less than 50ng/m3 in 8 hours TWA. The new cytotoxic facility is 3b category and provides full protection for the operator, environment and product when handling cytotoxic compounds throughout PSL high containment systems.
