Planova™ BioEX filters are validated to deliver LRVs of 4.0 or greater for parvoviruses (e.g. PPV, B19 and MVM), which are among the smallest known viruses. This high removability of small viruses is sustained even under large loading volumes, as shown in the figure on the right. Planova™ BioEX filters also exhibit outstanding protein recovery rates, as shown in table below.
Protein Recovery Rates
|Polyclonal IgG (30 mg/mL)||Monoclonal IgG (20 mg/mL)|
|Planova™ BioEX||> 95%||> 98%|
Planova™ BioEX filters are suitable for high pressure and high concentration filtrations. The figure titled "Flux vs. Filtration Pressure" on the right shows that Planova™ BioEX demonstrates an excellent correlation between filtration pressure and water flux, which stays proportional even at high pressures. The figure titled "Throughput vs. Concentration" shows that Planova™ BioEX maintains a high protein throughput of 6.5 kg/m²/3 h at filtration pressure of 294 kPa (42.6 psi), demonstrating the filter's resistance to high operating pressures and high concentrations.
Planova™ BioEX membrane material and cartridge elements are constructed with strength and integrity that enable the filter to withstand in-line sterilization by Steam-in-Place (SIP).
Planova™ BioEX filters demonstrate consistent performance across all production lots of the hollow fibers contained. These hollow fibers are manufactured on dedicated spinning lines during continuous periods, and each period of continuous spinning on each spinning line is termed a “spinning series”. A "lot" of Planova™ BioEX filters is considered to be all of the filters manufactured using hollow fibers from the same spinning series. The figure on the right shows that three 1.0 m² Planova™ BioEX filters, each containing hollow fibers from separate spinning series, exhibit very similar water fluxes. From this, it can be stated that Planova™ BioEX filters exhibit reliable lot-to-lot consistency.
Like Planova™ 15N, 20N, 35N and 75N filters, Planova™ BioEX filters exhibit linear scalability across various membrane surface areas. Each filter size uses the same housing format and is filled with a scaled number and length of hollow fibers. This yields reliable scalability from laboratory scale filter sizes to commercial manufacturingscale filter sizes. Planova™ BioEX filters are available in 0.0003 m², 0.001 m², 0.1 m², 1.0 m², and 4.0 m² sizes.