It is targeted at the pharmaceutical and biotechnology industries, which have high demands for sterilisation- and clean-in-place (CIP and SIP). The mixer eliminates the contamination issues related to flanges that penetrate the production vessel wall, according to Neil Robinson, the UK product manager for the Cyclone. This minimises maintenance times and facilitates cleaning in place of the complete mixer assembly.
He told In-Pharmatechnologist.com that the Cyclone will increase productivity as well as decrease validation times, by eliminating the downtime associated with the disassembling of mixers for cleaning.
In addition, small batch volumes can be processed due to the mixing head position within the vessel, and this has the positive effect of minimising the costs associated with product wastage.
"Fear of product contamination in the pharmaceutical, biotechnology and food industries is not a new phenomenon, but due to increasing product value, the problem is of growing concern," it said.
Spoiled batches, increasing costs, the disruption of production schedules and, at worst, product recall can be the devastating consequences of poor cleaning techniques associated with top mounted and flange connected mixing systems, said NovAseptic.
Advances in sealing techniques in rival flange or top-counted systems, using methods such as cartridge and gas seals can only control leakages it maintained. "They do not guarantee zero ingress/egress over the lifetime of a product."
Robinson told In-Pharmatechnologist.com that the mixer is suitable for use in vessels up to 500 litres in capacity, although additional versions are in development that will extend the range. As a high shear mixer it is suitable for applications such as homogenising, suspending and emulsifying.
The seal-free magnetic mixing technology used in the Cyclone T60 is already used in NovAseptic's low shear NA-Mixer product, which has a capacity of between 10 and 30,000 litres and is typically used to keep substances in suspension.
The company is currently working on a larger version of the Cyclone that should handle larger volumes - perhaps up to 2,000 litres - and in time hopes to provide high shear mixing right up into the 30,000-litre range.