The trend towards increasingly potent products will cause production, cleaning and safety issues
Helsinn Advanced Synthesis is currently building a new facility in Biasca, Switzerland to manufacture highly potent active pharmaceutical ingredients (HPAPIs). The challenge was to build a factory capable of handling the actual HPAPI but also to handle even more potent products in the future.
The pharma industry is developing more and more potent oncology drugs, hormones and other products. This trend is expected to shift to even more potent products in the near future, which will cause production, cleaning and safety issues. Equipment must therefore meet this criterion now to ensure suitability to increased potent handling in the future.
Powder Systems (PSL) has been chosen by Helsinn to provide two PSL FilterBoxes – agitated nutsche filter dryers (ANFDs) with high containment that fulfil the requirements of HPAPI production. The FilterBox is an ANFD with a contained discharge and base.
The HPAPI production process demands a very low exposure level. PSL’s experience with handling highly potent products brought the decision that the production and cleaning operation would be completely contained.
The filter dryers that are currently being engineered will achieve cleaning below 2ppm after reflux. A further critical consideration was to be able to clean additional parts, such as the drainpipe, which could potentially contain some HPAPI. With the ANFD inside a containment system, the user can easily dismantle these critical parts in a contained manner, clean them and reinstall them safely.
Helsinn has been working with PSL products for 12 years. In further support of the new facility in Biasca, PSL will also provide a full process, complex high containment system that will house complete small-scale synthesis. The system will include reactions, filtration and drying, incorporating PSL’s new CakeStand Tray Dryer technology.
PSL will be exhibiting a laboratory glass filter dryer GFD within a high containment glovebox on stand 40H59 at P-MEC Europe.