US-based Koch Membrane Systems (KMS) has introduced a crossflow pilot system for pharmaceutical and biotech applications for the European market.
The use of crossflow filtration in the pharma industry has increased considerably during the last few years, and is said to offer a number of key benefits. These include lower investment and operating costs, higher product yields and simplification of downstream processing methods.
The new SPIRAPRO PharmaPilot system is a compact crossflow MF, UF, NF and RO filtration system that allows the development and scale-up of the major relevant process parameters for large-scale production in accordance with current good manufacturing practice (cGMP) guidelines.
It covers the whole range of pharmaceutical and biotechnological crossflow applications such as clarification, concentration, fractionation, desalting and purification, while providing suspended solids removal, protein concentration, removal of macro molecules and proteins to enhance downstream recovery, recovery of peptides, antibiotics, radio imaging contrast media, and catalysts.
Additional applications include desalting of product streams and concentration of small molecules in aqueous solutions to reduce volume for lyophilisation.
The SPIRAPRO PharmaPilot system accommodates 2540 style spiral wound membrane elements and has the ability to operate one or two housings in series or parallel. It features a 25-litre process vessel with the option to upgrade to 100 litres or connection to an external process vessel.
Operating pressure is up to 40 bar with a speed controlled feed/recirculation pump to allow pressure and flow variation. An ATEX compliant control panel is mounted on the system skid for data acquisition of the main operating parameters. Materials of construction have been carefully selected to enable processing of either aqueous or organic solvent streams.
The pilot system hold-up volume of 5 litres enables processing with a limited sample volume while enabling a reasonable volume concentration. Each system is supplied with a complete documentation package to validate the system design and provide for traceability of all materials of construction.