Germany's Sartorius will distribute a novel disposable mixing system developed by LevTech of the US that makes use of a novel mixing impellor that levitates on a magnetic field, reports Phil Taylor.
The product - the DB-200E/EA - is designed for mixing applications in the biopharmaceutical sector, where there has been a drive towards the use of disposable equipment to reduce the labour and time of clean- and sterilise-in-place cycles required for stainless steel apparatus, as well as lowering the risk of product contamination and hiking production throughput
The disposable bag-based system was first launched onto the market around two years ago in a benchtop format, and since then LevTech has refined the design, gradually increasing the size and capacity of the bags available for the system.
Sartorius has come on board just as the company has scaled up to 1,000 litre bags, although at the moment it has only carried out mixing studies up to 200l. This volume is suitable for process development tasks, pilot scale production and the manufacture of clinical trial materials.
The system uses a traditional impeller-based mixing, but because the disposable impeller floats in the bag and is driven by a magnetic force from outside it - unlike disposable magnetic stir bars that rest on the bottom of the vessels - there is no risk of particle or heat generation and cell shearing is reduced, said a spokesman for the firm. Stir bars have been known to wear through the lining of bags.
Moreover, as the mixer has no shafts, seals or bearings there is less to go wrong with the mixer mechanically, which should reduce maintenance.
"The use of the DB-200E/EA has been shown to reduce hardware and facility capital requirements, bacterial and cross contamination, labour and energy requirements, while allowing more productive use of valuable human and facility resources," said the company.
The system is portable, so it can be moved around the production facility, according to LevTech.
The spokesman said that the price of the impeller drive unit is in the region of $40,000, with another $3,000 required for the portable dolly unit. Along with the disposable bags, a typical start-up configuration would cost in the region of $45,000, he said.
Under the terms of the agreement, Sartorius will hold exclusive, worldwide rights to maret and distribute the levtated mixing technology. Financial terms of the agreement have not been disclosed.