Constant, stable flow rate-performance filters for precise, economical scale-up in virus filter process developmentWith the ever-present risk of virus contamination in biologic products, potential sources of virus contamination of biotechnology products include viruses associated with cell lines (endogenous viruses), or viruses introduced into the cell line or product from culture medium or during the production process (adventitious viruses). Viruses could also potentially be present in donations for plasma derivatives.
The Mini Kleenpak Capsule Filterability Tool with Pegasus SV4 virus removal filter membrane is designed for quick and efficient filter sizing studies using small fluid volumes either following, or instead of bench scale flat disc trials. Studies performed using this device predict filtration area requirements of Pegasus SV4 membrane in larger, AB-style filter cartridges or Kleenpak Nova filter capsules. These full-process scale formats utilize a laid-over-pleat membrane construction to maximize available filtration area per filter element (2.25 m² per 254 mm [10 inch] module). Consult the relevant product datasheets USD2847 Pegasus SV4 Virus Removal Filter Cartridges, and USD2856 for Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane.
|Precise scale-up1||Enables reliable, accurate scaling of flow rate and filter throughput; minimizes oversizing of large-scale virus filtration|
|Reliable down-scaling||Large-scale filter operating conditions can be applied, assuring consistently high quality|
|Small fill volume||Economical; minimizes amount of fluid required|
|100% quality-tested||Assures consistent performance|
1 Mini Kleenpak Capsule Filterability Tools are for filter-sizing studies and evaluation during process development only. They are not qualified for virus removal. Pall Corporation provides filters for use during drug manufacture or for animal, human therapeutic or diagnostic needs. Please contact Pall for details of filters where needed as Mini Kleenpak Capsule Filterability Tools are not intended for these purposes.
Materials of Construction
|Membrane||Hydrophilic modified polyvinylidenedifluoride (PVDF)|
|Capsule Shell, Core and Endcaps||Polypropylene|
|Sealing Technology||Thermal bonding without adhesives|
|Maximum Operating Temperature||38°C|
|Maximum Operating Pressure||4.1 barg (60 psig)|
|Recommended Operating Differential Pressure||2.1 to 3.1 bard (30 to 45 psid)|
|Maximum diameter including valves||53 mm (2.1 in.)|
|Length||105 mm (4.1 in.)|
|Nominal Effective Filter Area (EFA)||580 cm2 (0.62 ft2)|
1 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction