|Technical Brief: Viresolve® Prefilter: Extractables Characterization|
|Viresolve® Prefilter - Custom protection for Viresolve® NFP viral clearance filters|
|Development and Qualification of a Novel Virus Removal Filter for Cell Culture Applications|
Shengjiang Liu, Mark Carroll, Raquel Iverson, Christine Valera, Joann Vennari, Kimberly Turco, Robert Piper, Robert Kiss, Herbert Lutz
Biotechnology Progress 2000
OptiScale-40 with Viresolve PrefilterThese small devices are useful for process development and optimization, and viral clearance studies
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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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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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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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Pod Filter HoldersPod Filter Holders with a new format offers linear scale-up and the flexibility to meet changing process needs.
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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.
Pods 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 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
Pod Disposable Devices
Scalable from pilot to process applications, this new innovative NFF device format offers process flexibility and linear scale-up.
This patented technology consists of three Pod sizes and an expandable holder system.
Pod Prefilters are offered in 0.1 m2, 0.5 m2 and 1 m2 filtration areas.
Two basic holders are available; the pilot scale holder is configurable with extension rods that can accommodate up to five 1 m2 Pods, while the process scale holder expands to mount from 5 to 30 Pod devices. The stainless steel holder is not wetted by product and the connectors are disposable plastic. With the compact, modular design of Millipore’s new Pod system, you can increase productivity, shorten cycle-time and reduce costs.
|Filtration Area||0.11 m²|
|Materials of Construction|
|Media||Cellulose fibers with inorganic filter aid|
|Membrane||Mixed Cellulose Esters (MCE)|
|Flat seal||Thermo Plastic Elastomer (TPE)|
|Housing Vent||Disposable vent|
|Maximum Inlet Pressure, bar (psi)||3.4 bar (50 psi) @ 23 °C|
|Maximum Differential Pressure, bar (psid)||Forward: 2.1 bar (30 psid). Reverse: 2.1 bar (30 psid)|
|Sterilization||3 autoclave cycles of 60 min @ 123 °C|
|TOC/Conductivity||Lot release testing on effluent exhibited TOC <4 ppm and conductivity <10 µS/cm after 3 autoclave cycles and a water flush of 100 L/m2|
|Metals||Lot release testing on effluent exhibited the following values:
Pb <0.11 mg/m2
Hg <0.11 mg/m2
As <0.012 mg/m2
Fe <1.1 mg/m2
Al <5.5 mg/m2
|Bacterial Endotoxins||Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|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|