Viresolve NFR Filters

Viresolve NFR Filters

Description
Viresolve NFR filters with Retropore^® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources. Viresolve NFR filters are ideal for polishing monoclonal antibodies, and provide an easy-to-implement technology that eliminates retrovirus contaminants in essential media and protein feed streams. When placed downstream of a bioreactor, Viresolve NFR filters minimize infection risk in products and processes caused by viruses common to mammalian cell expression systems.


Fast, Reliable Clearance
Cast from polyethersulfone, Retropore membrane exhibits a patented void-free pore structure characterized by superior clearance and high flow rates. Denser internally than on its surface, the asymmetrical matrix of the membrane effectively traps large viruses and efficiently passes smaller proteins.

By providing fast and highly reliable clearance, Viresolve NFR filters improve product safety and protect downstream processes.


High Yields and Product Quality
Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide > 98% protein product yields, while low extractables ensure product quality. Retropore membrane technology passes proteins up to 700 kDa and consistently clears retroviruses at > 6 LRV (Log Reduction Value).


Regulatory Compliance
All Viresolve NFR filters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO^® 9001 Quality Management System.
Viresolve NFR cartridge filters are integrity tested during manufacturing and supported by a Validation Guide to assist in compliance with regulatory requirements. For traceability and easy identification, each filter is labeled with the product name and identifying characteristics. Every Viresolve NFR filter is shipped with a Certificate of Quality.

Millipore has submitted a Biological Master File to the FDA and will submit it to other worldwide regulatory agencies needed to support customer applications. Please contact Millipore to obtain a Letter of Authorization to reference in your application.


Virus Retention
Pleated filters have been extensively tested using the 78 nm diameter F6. This bacteriophage is readily grown to monodispersed, uniform size, high titer challenges. A consistent > 6.5 LRV has been observed over the range of feedstock and processing conditions


Multiple Formats Available
Viresolve NFR with Retropore membrane is available in three formats and multiple configurations that vary by filtration area and the type of inlet/outlet connection. Choose the format that’s right for your process requirements:
- OptiScale^®-25 disposable capsule filters
- Opticap XL and XLT disposable capsule filters
- Cartridge filters


Cartridge Filters
Viresolve NFR 10-, 20- and 30-inch cartridge filters are ideally suited for processes that require maximum pressure differentials. Each cartridge is integrity tested during the manufacturing process. A range of filtration areas is available to suit medium and large volume requirements.


Specifications    (return to top)

Cartridge Filters (per 10-inch cartridge) Materials of Construction Filter Polyethersulfone O-ring Silicone O-rings Cage; Core; Support Polypropylene Effective Filtration Area, m2 0.43 Maximum Differential Pressure, bar (psid) Forward - 5.5 (80) @ 25 °C; Reverse - 3.5 (50) @ 25 °C Sterilization Can be sterilized by SIP of 30 min @ 126 °C; 3 autoclave cycles of 20 to 60 min @ 126 °C; shipped non-sterile Wetting/Flushing Water for 10 min at 2 bar (30 psi) Non-volatile residue (NVR) The extractables level after a 10 minute 1.5 Lpm/ft2 flush was ≤7 mg/ft2 after 24 hours in ASTM Type 1 reagent-grade water at controlled room temperature Bacteriophage Retention Lot release testing on samples exhibited > 6 LRV for F6 (78 nm) at a challenge of 107pfu/cm2 Bacterial Endotoxins <0.5 EU/mL as determined by the LAL test Non-Fiber Releasing Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). Oxidizable Substances Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 4000 mL Toxicity Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. Air Diffusion Rate, at 23°C ≤16 mL/min @ 3.4 bar (50 psig) in water Thermal and Hydraulic Stress Lot release testing on autoclaved samples at 25 °C exhibited integrity after a forward stress to 5.5 bar (80 psid) and a reverse stress to 3.4 bar (50 psid). Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.