Powder Systems Ltd (PSL) supports Helsinn Advanced Synthesis SA's expansion into the cytotoxic market with their revolutionary contained filtration and drying technology.
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 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 their 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 in June 2012.
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 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's 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.
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 their cytotoxic facility 3b category.
Due to the characteristics of their products, it was crucial that they could open the vessel base completely and manually clean 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 will be displayed on PSL's stand C31, Hall 5.1 at ACHEMA 2012. Visitors will be able to see a production scale isolator surrounding an ANFD with a filtration area of 0.125m². The filter dryer has a 10kgs 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 kindly agreed to provide Achema visitors with an exclusive opportunity to see this revolutionary high containment filtration and drying solution before installation at their new cytotoxic facility in Biasca, Switzerland.
Visit PSL at Achema, Frankfurt in June 2012, Hall 5.1 stand C31, to see the FilterBox and learn more about Powder Systems Ltd (PSL) and Helsinn Advanced Synthesis SA (HAS).
PSL press contact:
Camille Flores - email@example.com - +44 (0)151 448 7700
Helsinn media Contact:
Helsinn Healthcare SA: Paola Bonvicini, Head of Communication & Press Office - +41 91-985-21-21
Helsinn Advanced Synthesis (HAS) contact:
Waldo Mossi, Senior Director Business Development, +41 91 873 94 00
Powder Systems Ltd (PSL) provides a full range of filtration, drying and contained powder handling products to worldwide industry leaders including Pfizer, GSK and BMS. From small-scale production to full process systems PSL's isolation products provide containment to nanogram levels for handling highly potent APIs.
PSL provides a full service that includes: OEL testing, installation, operator training, aftercare, reliable spare parts and emergency call out to anywhere in the world. PSL has been established for 23 years and has offices and distributors worldwide to easily assist their global customer base.
Powder Systems Limited (PSL)
+44 (0)151 448 7700
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and USA. Helsinn's business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group inlicenses early to late stage new chemical entities and completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC) development to the filing for and attainment of their market approval worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The APIs and the finished dosage forms are manufactured at Helsinn's cGMP facilities in Switzerland (HAS) and Ireland (HBP), and supplied worldwide to its customers.
For more information about Helsinn Group, please visit the website: www.helsinn.com