Contained cytotoxic installation for in-line clinical trial production

Powder Systems Limited (PSL) supports the expansion of Helsinn Advanced Synthesis into the cytotoxic market with its recently installed clinical trial isolator

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.

Clinical trial isolator back view

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.

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