Articles

The performance of the tangential filtration associated with the single use.

That it is of ultrafiltration or microfiltration, the technique of tangential flow or crossflow is used to limit filling on the surface of the membranes.

By ultrafiltration 4 main aims are achieved

            -     Concentration of macromolecular solutions

–      Retention of macro more or less harmful aqueous solutions

–      Fractionation by retention of small aqueous solutions

–      dia filtration of an aqueous solution

Tangential microfiltration gives the possibility 

–      dia to filter or ` ' to wash'' a solution 

–      to concentrate this same solution

–      like extracting from them a filtrate removed from its suspended particles

Contrary to frontal filtration, tangential filtration makes it possible to recover retentât it and/or the filtrate.

This technology is largely employed in the companies of biotechnology for applications such as the purification of vaccines, monoclonal antibodies or recombining proteins.

Thanks to the implementation of a innovating technology, tangential filtration makes it possible to be associated with a solution of single use ready with employment. Indeed all the elements in contact with the product are of single use, deads and ready with employment to work in an environment GMP for industrial development, the phases clinical and the small commercial productions.

A system equipped with a gamma-sterilized complete loop including the cassettes of tangential filtration, the pressure controllers, the flowmeters, of the valves, pocket and pipes answers entirely this requirement.

This technology ready with employment allows

–      to increase the safety of the process thanks to an entirely closed ensuring the protection of toxic products or pathogenic system,

–      to reduce times of process and to increase by it the effectiveness thanks to the reduction of the time of qualification, the elimination of the stages of cleaning and sterilization,

–      to increase flexibility while being more reactive for the startup of a new process.

A frame crossflow especially developed for the cassettes developing of 0.1 at0.3 m2filtering surface. The cassette has the same hydrodynamic design as the large cassettes of production, thus allowing an extrapolation linear scale. The cassettes pre-are rinsed, individually tested and gamma sterilized. Thus after the installation of the totality of the loop, operation which takes approximately 10 minutes, the user can immediately start his production without having to rinse, sanitiser or to eliminate its chemical solution from sanitisation for example.
 

This simplicity of implementation makes it possible to compel stages of qualification, validation of the stages of sanitisation, as well as regeneration of the cassettes of tangential filtration.

A very compact system will make it possible to treat small volumes under aseptic conditions, on a straw mattress of laboratory for example.

A system equipped with a touch screen. and thanks to sterile and gauged sensors, will allow to ensure the stages of an automatic process of way, for example by regulation of the PTM or the flow of recirculation. Such a unit resistant to water could be used uninterrupted in laboratory or production zone. A control unit and a module of filtration will facilitate the handling of the system. This compatible unit 21 CFR Part11 and could be connected to an operating system Scada.