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 is in the process of building a dedicated cytotoxic facility. 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 the cytotoxic facility and is providing a suite of high containment systems, including contained agitated nutsche filter dryers (ANFDs). One of the contained ANFDs produced for the facility will be on show at Achema on stand C31 in hall 5.1.
Helsinn's cytotoxic facility comprises a small-scale GMP area for the production of reduced quantities of cytotoxic active pharmaceutical ingredients (APIs) for clinical and registration purposes that will be available in June 2012. PSL will install an innovative clinical trial isolator into this small-scale GMP area. Numerous operations will be processed inside this high containment isolator ,including small-scale reactor charging, reaction with glass reactor of 20L or hydrogenation, filtration, drying, dispensing and packing with an operator exposure level (OEL) of less than 50ng/m3 in 8 hours TWA.
The PSL production FilterBox on site
The cytotoxic plant is due to open two further production areas in January 2013. PSL will provide two charging gloveboxes with slurry vessels and also two FilterBoxes (Hastelloy pressure filter dryers with high containment).
PSL's FilterBox technology
The FilterBox is the optimum contained filtration and drying solution for handling cytotoxic compounds. The FilterBox allows the following operations to be performed in one unit in a completely contained environment:
- Filtration and drying
- Contained sampling
- Discharging, dispensing and packing
- Safe and contained base opening and washing
- Filter mesh inspection and changing
The FilterBox consists of a lab-to-production size PSL filter dryer (0.002m2 to 0.3m2) surrounded by a high containment glovebox isolator for the ultimate containment solution. The two FilterBoxes to be installed in Biasca will have a filtration area of 0.125m2 and 0.3m2. PSL's filter dryers are specifically designed for handling potent and cytotoxic products and comprise numerous design features for high performance including: PSL’s minimum volume clamp base design, PSL tapered filter plate for optimum seal, full heating jacket to maximise heat transfer, one piece agitator equipped with omega wave bellows and more.
The PSL production FilterBox
Even with the efficient CIP and reflux cleaning systems incorporated into PSL’s filter dryer, HAS required higher containment with an OEL test result of <50ng/m3 during the sampling period for its cytotoxic facility 3b category.
Due to the characteristics of the products, it was crucial that the vessel base could be opened completely to enable the manual cleaning of some critical areas in a contained manner. With the FilterBox, the cleaning procedure can be performed safely and thoroughly as the complete vessel base, filtration media and discharge plug can be accessed in a completely contained environment.
The FilterBox is being displayed on Stand C31, Hall 5.1 at ACHEMA 2012. Visitors can see a production scale isolator surrounding an ANFD with a filtration area of 0.125m2. The filter dryer has a 10kg product capacity, with 150mm cake depth and an Hastelloy 22 construction. The vessel is designed in accordance with ASME VIII, Div 1, 2010 and operates at a minimum temperature of -25°C and a maximum temperature of +165°C.
Helsinn has kindly agreed to provide ACHEMA visitors with an exclusive opportunity to see this revolutionary high containment filtration and drying solution before installation at the new cytotoxic facility in Biasca.
