Viresolve NFP Cartridge Filters

Viresolve NFP Cartridge Filters

Description
Viresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates. Viresolve NFP filters add speed and dependability to viral clearance in therapeutic drug manufacturing applications. Operated in normal flow filtration mode, these filters are ideal for monoclonal antibody polishing applications eliminating small virus contaminants from essential media and feed streams containing dilute peptides. When placed upstream of bioreactors, Viresolve NFP filters minimize infection risk caused by viruses common to mammalian cell expression systems.

For plugging streams Millipore recommends the Viresolve Prefilter for use with Viresolve NFP filters. This robust filter configuration improves NFP filter capacity significantly reducing your overall virus filtration costs.


Rapid, Reliable
Composed of a patented PVDF material, Viresolve NFP membranes possess a unique pore structure with characteristics that enhance filtration efficiency. Excellent flow-through qualities allow NFP membranes to provide highly efficient separations at flow rates 6 to 10 times faster than competitive products. Inherent sizeexclusion properties reliably retain specific-sized contaminants, improving product safety and protecting downstream processes.

The Viresolve Prefilter is available for use in series with Viresolve NFP filters. The prefilter effectively removes fouling material from biotech feeds and improves filtration economics by protecting the Viresolve NFP viral clearance filters.


Regulatory Compliance
All Viresolve NFP filters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO^® 9001 Quality Management System.
Viresolve NFP small area devices, capsules and cartridges 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 NFP 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.


Delivers High-Quality Filtered Protein
Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide >98% protein product yields. Low extractables ensure product quality.

Viresolve NFP size-exclusion membrane technology passes proteins up to 160 kDa in size and consistently clears parvovirus at >4 logs, without compromising flow rate.


Multiple Formats Available
Viresolve NFP membranes are offered in multiple device configurations that vary by filtration area and inlet/outlet connection type. Viresolve NFP filter units are available as OptiScale 25 mm devices, Opticap capsules, and cartridge filters that accommodate volumes ranging from 70 mL through thousands of liters at process scale.


Cartridge Filters
Viresolve NFP 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 Modified PVDF O-ring Silicone Cage; Core; Support Polypropylene Effective Filtration Area, m2 0.42 Maximum Differential Pressure, bar (psid) Forward: 5.5 (80). Reverse: 3.5 (50) Bacteriophage Retention ≥4 LRV for FX-174 (28 nm) at a challenge of 107 pfu/cm2 Bacterial Endotoxins <0.5 EU/mL as determined by the LAL test Sterilization Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min 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. Non-Fiber Releasing Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. Air Diffusion Rate, at 23°C ≤10 mL/min @ 3.45 bar (50 psig) in water Wetting/Flushing Water for 5 min at 3.4 bar (50 psi)