Contained Cytotoxic Installation for In-Line Clinical Trial Production
Powder Systems Ltd is supporting Helsinn Advanced Synthesis SA’s expansion into the cytotoxic market with its recently installed clinical trial isolator. Helsinn Advanced Synthesis SA (HAS), located in Biasca, Switzerland, is the chemical manufacturing business unit of the Helsinn Group. To meet the demand of 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 clinical trial isolator.
Helsinn’s cytotoxic plant comprises a small scale GMP area for the production of reduced quantities of cytotoxic APIs for clinical and registration purposes. PSL recently installed the clinical trial isolator into this small-scale GMP area. Numerous operations will be processed inside the high containment isolator.
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 20 l, Buchner filtration and drying within PSL’s CakeStand tray dryer. The 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, a pivot door and is contained in a PSL isolator to ensure high containment during transfer of the cytotoxic compounds.
The full synthesis containment system has HMI/PLC control, washing and CIP capabilities, with an OEL of <50 ng/m3 in eight 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.
Powder Systems Limited, +44 151 448 7700, info@powdersystems.com, www.powdersystems.com.