|Technical Brief: Viresolve® Prefilter: Extractables Characterization|
OptiScale-25 Capsules 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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Viresolve Prefilter Pod Disposable DevicesCustom protection for Viresolve NFP viral clearance filters
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|Dialysis and Filtration|
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|Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration|
The Viresolve Prefilter will improve the filtration economics of the viral clearance step by providing protection for Viresolve NFP viral clearance filters. Use of this prefilter with NFP will improve capacity and increase the life of the NFP filter. Available in scalable filter formats, this prefilter will easily fit in existing development and manufacturing processes.
Enhanced Viral Clearance
Viresolve NFP filters clear parvovirus from recombinant feed streams without compromising flow rates, adding speed and dependability to viral clearance in therapeutic drug manufacturing applications. These reliable filters are ideal for monoclonal antibody polishing applications eliminating small virus contaminants.
Improves NFP capacity reducing overall filtration costs
- Maintain high product yields
- Simple, predictable scale-up and scale-down
Increased Capacity and Filter Life
Utilizing this prefilter in series with Viresolve NFP filters (NFP) will allow you to take advantage of NFP’s high flow rates and product yield. The prefilter effectively removes fouling components of the feed, leading to dramatic increases in the performance of the Viresolve NFP filter. This improved capacity significantly reduces the cost of the viral clearance step.
Viresolve Prefilters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO® 9001 Quality Management System.
For traceability and easy identification, each filter is labeled with the product name and identifying characteristics. Every filter is shipped with a Certificate of Quality.
Multiple Formats Available
Viresolve Prefilters are offered in multiple device configurations.
- OptiScale™-40 small scale disposable capsule filters
- Opticap™ disposable capsule filters
- Pod disposable devices
OptiScale-40 Small Volume Disposable Capsule Filters
OptiScale-40 disposable capsule filters provide an active filtration area of 5 cm2. These small devices are useful for process development and optimization, and viral clearance studies. A female Luer–Lok®/male Luer slip connection ensures fast and secure setup. These capsules are used in small volume applications where feedstock requirements are minimal.
|Filtration Area||5 cm²|
|Materials of Construction|
|Media||Cellulose fibers with inorganic filter aid|
|Membrane||Mixed Cellulose Esters (MCE)|
|Maximum Inlet Pressure, bar (psi)||4.1 bar (60 psi) @ 23 °C|
|Maximum Differential Pressure, bar (psid)||Forward: 2.1 bar (30 psid). Reverse: 0.03 bar (0.5 psid)|
|Sterilization||3 autoclave cycles of 60 min @ 123 °C|
|Component Material 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.|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|
|Quality Standard||These products are manufactured in accordance with a Quality Management System that is approved by an accredited registering body to the appropriate ISO® 9001 Quality Systems Standard|