|Technical Brief: Viresolve® Prefilter: Extractables Characterization|
|OptiScale-25 Capsule Filters with Viresolve® NFP or NFR Membrane|
Viresolve NFP Cartridge FiltersViresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates.
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Opticap XL and XLT Disposable Capsule Filters with Viresolve NFP MembraneViresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates.
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OptiScale-40 with Viresolve PrefilterThese small devices are useful for process development and optimization, and viral clearance studies
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|Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration > Viresolve Pro & Pro+ > Viresolve NFP|
|Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration|
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.
Composed of a 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 size-exclusion properties reliably retain specific-sized contaminants, improving product safety and protecting downstream processes.
Convenient and Easy to Use
Autoclavable, easily installed, and quickly integrity tested, single-use Viresolve NFP filters are designed to minimize the time and expense associated with assembling, cleaning and validation.
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.
The Right Size
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 cartridges that accommodate volumes ranging from 70 mL through thousands of liters at process scale.
OptiScale-25 Small Volume Disposable Capsule Filters
OptiScale-25 capsules with Viresolve NFP membrane are used in small volume applications where feedstock requirements are minimal. Providing an active filtration area of 3.5 cm2, these small devices are useful as an evaluation tool for impurity studies, protein passage studies, membrane area determination, and virus validation. A female Luer-Lok™/male Luer slip connection ensures fast and secure setup.
OptiScale-25 disposable capsule filters are sold in Evaluation Kits that contain 9 devices, either 3 each from different membrane lots or all 9 from a single membrane lot. These are ideal for use in validation and sizing studies with Millipore’s Low Hold Up Volume Vmax™ Test Kit.
|Materials of Construction|
|Filter||Modified Polyvinylidene Fluoride (Modified PVDF)|
|Effective Filtration Area||3.5 cm²|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid). Reverse: 0.7 bar (10 psid)|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (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 Good Manufacturing Practices.|
|Wetting/Flushing||Water for 5 min at 3.4 bar (50 psi)|