Viresolve Prefilter Pod Disposable Devices

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Overview
Specifications
Ordering Information
Documentation
Operational Excellence Dossier
| Title | 
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References
| Reference overview | 
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| 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 | 
Related Products & Applications
Product Families
|   
 OptiScale®-40 with Viresolve® PrefilterThese small devices are useful for process development and optimization, and viral clearance studiesLearn More >> | 
|   
 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.Learn More >> | 
|   
 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.Learn More >> | 
|   
 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.Learn More >> | 
|   
 Pod Filter HoldersPod Filter Holders with a new format offers linear scale-up and the flexibility to meet changing process needs.Learn More >> | 
Related Products By: Application Facete
| Antibody Purification | 
| Protein Purification | 
| Dialysis and Filtration | 
Related Products By: Brand Facete
| Viresolve® | 
Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration > Viresolve Pro & Pro+ > Viresolve Pro and Pro+ | 
Description
The Viresolve® Prefilter removes protein aggregates and improves the robustness of virus filtration operations. Implementing the Viresolve® Prefilter improves the capacity of the Viresolve® Pro Device, results in more consistent filtration performance, and improves overall process economics.
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.
Regulatory Compliance
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 supported by a Certificate of Quality.
Multiple Formats Available
Viresolve® Prefilters are offered in multiple device configurations.
- OptiScale™ 40 small scale disposable capsule filters 
- Pod disposable devices (0.1 m2, 0.5 m2 and 1 m2 filtration areas).
Pod devices are offered with an expandable holder system: the pilot scale holder can accommodate up to five 1 m2 Pods, while the process scale holder expands to mount from 5 to 30 Pod devices. With the compact, modular design, you can increase productivity, shorten cycle-time and reduce costs.
Pod Disposable Devices
Scalable from pilot to process applications, this new innovative NFF device format offers process flexibility and linear scale-up.
Flexible Configurations
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 | |||||
| or | 0.55 m² | |||||
| or | 1.1 m² | |||||
| Materials of Construction | ||||||
| Media | Cellulose fibers with inorganic filter aid | |||||
| Membrane | Mixed Cellulose Esters (MCE) | |||||
| Housing | Glass-filled polypropylene | |||||
| 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 | |||||

 


 
  

 
 
