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Planova BioEX

Planova™ BioEX 1.0 m²

Hydrophilized Polyvinylidene Fluoride

The Planova BioEX filter membrane incorporates hydrophilized polyvinylidene fluoride (PVDF), a very robust polymer, enabling the filter to cope with the complex processing conditions typical in state-of-the-art biopharmaceutical manufacturing.

The PVDF membrane is made hydrophilic by graft polymerization. Planova BioEX filters safely and efficiently filter large volumes (high flow rates) even under demanding conditions such as high-protein concentration and high-filtration pressure.

Key Features:
1. Optimized for high-protein concentrations
2. Suited to high-pressure filtration
3. SIP (steam in place) compatible
4. Validated virus filtration, even with small parvoviruses.
5. Various filter surface areas make for easy scalability

Effective for High-Pressure & High-Concentration Usage

Research data supports the use of Planova BioEX filters for high-pressure, high-concentration filtrations.

Correlation between flow rate of 3%-h-IgG solution and filtration pressure

Relationship between h-IgG throughput and h-IgG concentration at 294 kPa (42.6 psi)

Removability of PPV, MVM and A-MuLV

High LRV for Parvoviruses & Larger Viruses

Planova BioEX filters can remove parvoviruses which are among the smallest known viruses found in nature, achieving levels below the detection threshold. Planova BioEX filters are validated to deliver > 4.0 logs of removal for PPV. For high productivity, this performance is sustained even for large-volume filtration of high-concentration solutions. Extensive testing of Planova BioEX filters validates performance for large viruses as well. For example, BioEX achieves > 5.5 logs for A-MuLV. 

Laboratory-Scale & Process-Scale

In addition to the 1.0 m² Planova BioEX filter for large-scale processing, the lab-scale 0.001 m² filter is for prototyping biological drug product manufacturing processes. Its smaller membrane surface area is convenient for scaled-down qualification or validation studies.

Standard Clamp Connections & SIP Capability

For easy integration into manufacturing processes, Planova BioEX 1.0 m² filters are designed for standard sanitary connections. Membrane material and cartridge elements are constructed with the strength and integrity to withstand steam-in-place (SIP) operations.