Pegasus™ SV4 Virus Removal Filter Membrane in Kleenpak™ Nova Filter Capsules product photo Primary L

Pegasus™ SV4 Virus Removal Filter Membrane in Kleenpak™ Nova Filter Capsules

Single-Use filter capsules with constant, stable flow-rates providing efficient, high viral clearance and significantly-reduced processing costs

With the ever-present risk of virus contamination in biologic products, potential sources of virus contamination of biotechnology products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the bioreactor from culture medium or during the production processes (adventitious viruses). Viruses could also potentially be present in donations for plasma derivatives.

Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane are encapsulated, direct flow filters that combine robust, high viral clearance of parvovirus and larger viruses with high throughput capacity and stable flow rates, in both dilute and complex concentrated biological fluids. Consistent flow rates and high throughputs provide superior control of process performance and costs. The encapsulated format removes operating costs associated with traditional formats, such as cleaning and maintenance of filter housings, and cleaning validation. Capsules can be autoclaved and supplied as part of a single-use processing system such as a filter/tubing/biocontainer set.

 
Features Benefits
Incorporates Pegasus SV4 virus filter membrane Offers robust, high parvovirus clearance (> 4 log reduction value)
Demonstrates constant, stable flow-rate performance Improves process and cost control, enables maximum virus filtration economy and efficiency
Highly-resistant to filter ‘plugging’ Shows outstanding throughput capacity in both dilute and complex/concentrated biological fluids
High filter area per cartridge Minimizes hold-up volume and system space requirements, reducing the Cost Of Goods Sold (COGS)
Automated in-situ integrity test both pre-use and post-use Provides easy, reliable integrity testing, reducing labor costs and minimizing the risk of handling errors
Fully encapsulated format Reduces operating costs, no cleaning validation required
In-line sanitization or autoclaving capability Low bioburden for filtration of non-sterile intermediates without autoclaving. Highest aseptic safety with autoclaving where required
Suitable for inclusion in Allegro™ MVP systems for single-use, fully-automated virus filtration Enables the highest level of process control and safety
 


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Description

Single-Use filter capsules with constant, stable flow-rates providing efficient, high viral clearance and significantly-reduced processing costs

With the ever-present risk of virus contamination in biologic products, potential sources of virus contamination of biotechnology products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the bioreactor from culture medium or during the production processes (adventitious viruses). Viruses could also potentially be present in donations for plasma derivatives.

Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane are encapsulated, direct flow filters that combine robust, high viral clearance of parvovirus and larger viruses with high throughput capacity and stable flow rates, in both dilute and complex concentrated biological fluids. Consistent flow rates and high throughputs provide superior control of process performance and costs. The encapsulated format removes operating costs associated with traditional formats, such as cleaning and maintenance of filter housings, and cleaning validation. Capsules can be autoclaved and supplied as part of a single-use processing system such as a filter/tubing/biocontainer set.

 
Features Benefits
Incorporates Pegasus SV4 virus filter membrane Offers robust, high parvovirus clearance (> 4 log reduction value)
Demonstrates constant, stable flow-rate performance Improves process and cost control, enables maximum virus filtration economy and efficiency
Highly-resistant to filter ‘plugging’ Shows outstanding throughput capacity in both dilute and complex/concentrated biological fluids
High filter area per cartridge Minimizes hold-up volume and system space requirements, reducing the Cost Of Goods Sold (COGS)
Automated in-situ integrity test both pre-use and post-use Provides easy, reliable integrity testing, reducing labor costs and minimizing the risk of handling errors
Fully encapsulated format Reduces operating costs, no cleaning validation required
In-line sanitization or autoclaving capability Low bioburden for filtration of non-sterile intermediates without autoclaving. Highest aseptic safety with autoclaving where required
Suitable for inclusion in Allegro™ MVP systems for single-use, fully-automated virus filtration Enables the highest level of process control and safety
 
Specifications

Technical Specifications

 
Item Material of Construction
Membrane Hydrophilic modified polyvinylidenedifluoride (PVDF)
Support and Drainage Layers Polyester
Core, Cage and Endcaps Polypropylene
Internal O-rings Silicone
Housing Bowl and Head Polypropylene
 

Operating Parameters*

 
Recommended Operating Differential Pressure 2.1 to 3.1 bard (30 to 45 psid)
Maximum Operating Pressure 5 barg (73 psig)
Maximum Differential Pressure 3.1 bard (45 psid) for continuous service, 6.2 bard (90 psid) during integrity testing only for up to a maximum of 10 hours
Autoclave Maximum 125 °C, 2 x 1 hour cycles
Maximum Operating Temperature 40 °C (104 °F)
 
* In compatible fluids that do not soften or swell, or adversely affect the filter or its materials of construction. For up to a maximum of 25 hours continuous service. Contact Pall for recommended procedures to qualify filters under actual conditions of use.


 
Pore size 20 nm (nominal)
Retention Ratings (Virus) > 4 log reduction value for
bacteriophage PP7**†
 
** Claims based on challenge with parvovirus model bacteriophage (bacterial virus) PP7

† > 4 log reduction value for bacteriophage PP7 per Parenteral Drug Association (PDA) Technical Report 41 rating method for small virus-retentive filters. > 4 log reduction value typically expected with mammalian parvoviruses


 
Aqueous Extractables (NVR) Refer to Pall Publication USTR 2839
Filter Area (Nominal) 2.25 m2 (24 ft2) per 254 mm (10 in.) filter
Forward Flow Integrity Test Diffusional flow integrity test, carried out by standard upstream or downstream methods
 


Table 2

Process Scale-Up with other Pegasus Grade SV4 Virus Filters
 
Filter Type Part Number Filter Area
Pall Minidisc Capsule 10MCFSV4 0.00096 m2
Filter Disc (47 mm) FTKSV4047 0.0011 m2 (in FTK200 Holder)
Mini Kleenpak Capsule KA02SV42FT*** 0.058 m2
1 in. Kleenpak Nova Capsule NP1LUSV4P16 0.25 m2
10 in. Filter Cartridge AB1USV47PH4 2.25 m2
10 in. Kleenpak Nova Capsule (In-Line Style) NP6LUSV47P1 2.25 m2
10 in. Kleenpak Nova Capsule(T-Style) NT6USV47P1 2.25 m2
 
Not all filter types can be steam-sterilized. Consult individual product datasheets for technical specifications.

This table shows the Pegasus SV4 product portfolio. Not all formats are available at the time of publication. For confirmation of available formats contact your local Pall representative.

*** Filterability Tool version (FT). Not qualified for virus removal. For filterability tests only
Performance

High Parvovirus Clearance

Pegasus SV4 Virus Removal Filter membrane demonstrates highly-efficient clearance of both small ‘non-enveloped’ viruses as well as large viruses. Figure 1 provides an example of its high parvovirus clearance by showing the typical performance of a Pegasus SV4 filter in a 1 g.L-1BSA solution, as per the PDA’s guidelines:

Figure 1

Retention of porcine parvovirus (PPV, n=4) and small spherical bacteriophage virus (PP7, n=9) by Pegasus Grade SV4 virus membrane in 1 g.L-1 BSA at 3.1 bar (45 psi)1
Figure 1
1 PPV retention testing was carried out at an independent virus validation test laboratory using 47 mm filter discs


Due to the high resistance to plugging and outstanding through - put properties of Pegasus SV4 membrane, typical viral spikes will not have significant impact on flux decay during viral retention studies.

Constant, Stable Flow-rate Performance, with Outstanding Throughput Capacity

With the need to control the Cost of Goods Sold now one of the main points of consideration in downstream processing, Pegasus SV4 Virus Removal Filter membrane has been designed to address this need by offering constant, stable flow rates and outstanding throughput capacity, thereby improving process and cost control and enabling maximum filtration economy and efficiency.

Highly-Efficient and Economical

Pegasus SV4 Virus Removal Filter Membrane also demonstrates highly-efficient clearance of both small ‘non-enveloped’ viruses and large viruses, providing constant flow rates with most biological fluids. It also offers stable pressure/flux capability with more complex or concentrated feeds, helping to improving virus filtration economy in highly-concentrated protein solutions. Figure 2 shows a typical flux profile for Pegasus SV4 Virus Removal Filter Membrane when challenged with monoclonal antibody solution.

Figure 2

Results of Filterability Tests at 2.1 bar (30 psi) or 3.1 bar (45 psi) with up to 25 g.L-1 (2.5 %) MAb
Figure 2
* Performance predicted from tests performed on Pegasus SV4 Virus Removal Filter Discs (47 mm)


Reduces Processing Costs

Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane offer a very high filter area (2.25 m² per 10 in. filter) due to their unique, patented high area filter laid-over pleating construction which enables significantly more filter membrane to be packed into each capsule. This helps to maximize process productivity while minimizing process costs, by the amount of filter capsules required per installation, and helps minimize the hold up volume of the virus filter system.

Figure 3

Laid-over pleat construction utilized by Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane
Figure 3

Superior Process Control and Safety

Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane offer the highest level of process control and safety in process scale virus filtration.

Process Requirement: Aseptic Safety

Best practice – Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane can be autoclaved and are suitable for inclusion into fully-automated Allegro™ MVP virus filter systems.

Process Requirement: Easy, Reliable Integrity Testing

Best practice – Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane can be in-situ integrity tested both pre-use and post-use.

Table 1

Sterilization and Integrity Testing of Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filters
 
Steam In Place (SIP) No
Autoclavable By User Yes
Integrity Test Pre-Use Yes (Non destructive, water-wet in situ)
Integrity Test Post-Use Yes (Non destructive, water-wet in situ)
 

Suitable for Inclusion in Pall’s Fully-automated Allegro MVP Single-use System

Pall offers fully-automated Allegro MVP systems for virus filtration with a completely single-use fluid path, ensuring precise and consistent operation and improved process efficiency. The systems can be designed with automated integrity-test-in-place (ITIP) for the installed filter capsules, and ensure the highest level of manufacturing safety and process performance.

Benefits include:
  • Significant reductions in Cost of Goods
  • Reduced labor, materials and facility operating costs
  • No cleaning or cleaning validation required
  • Ease of use and flexibility for different processes
  • Increased productivity in manufacturing
  • Better resource allocation
  • Effective capacity utilization
  • Robust operation and minimal risk of operator error
  • Enables precise and consistent operation
  • Built-in, non-destructive automated integrity-testing-in-place

Figure 4

Fully-automated Allegro MVP Single-use System for Virus Filtration
Figure 4

Figure 5

Kleenpak Nova Filter Capsules undergoing Integrity Testing
Figure 5

Rigorous Quality Testing at Multiple Stages of Production

Throughout the process of manufacture of Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane, Pall’s rigorous quality control systems ensure consistent performance as per the product specification.
  • Quality Control at Multiple Production Stages
  • 100 % fabrication integrity tested – correlated to PP7 bacteriophage removal
  • Viral reduction tested with PP7 bacteriophage lot release test
  • 100 % fabrication water flow tested
  • Protein transmission tested
  • Visual inspection control

Full Traceability, Fast and Efficient Data Entry

Every capsule is manufactured under a Quality Management System certified to ISO 9001:2008, and is identified by a part number with unique lot and serial numbers, to allow complete traceability of the product manufacturing history, and to assist the user’s own traceability systems.

High Quality Standards

The filter components have met requirements for biological reactivity, in vivo, under USP <88> (for Class VI – 121 °C plastics) and in vitro, under USP <87> (Elution Test).
  • Meets Cleanliness per USP <788> Particulate Matter in Injections
  • Non-Fiber-Releasing per Title 21 of the U.S Code of Federal Regulations (CFR) parts 211.72 and 210.3 (b) (6)
  • Non-Pyrogenic per USP <85> Bacterial Endotoxins Test
The filter cartridge does not contain materials of construction that are considered specified TSE or BSE risk materials according to current legislation and guidelines (reference European CPMP EMA/410/01 and U.S. Code of Federal Regulations, Title 21 Part 189.5).

Scientific and Laboratory Services

Pall’s Scientific and Laboratory Support (SLS) Global Technical Support group is available to provide you with the scientific and technical support you need to mitigate risk as part of your viral safety strategy. Our scientists have extensive experience in filtration and chromatographic methods, validating processes developed to prevent virus contamination, and developing standard operating procedures for the correct operation of virus removal technology in unit operations. Our experience also covers the necessary skills and expertise to appropriately document the entire approach, from test protocols that include scientific rationale related to methodology and sampling, to test execution including data analysis, followed by scientific report generation ready-prepared for regulatory submission.
Ordering Information
 
Part Number3 Item Length
(Nominal)
Filter Area
(Nominal)
NP1LUSV4P1 Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style) 129 mm
(5.1 in.)
0.25 m2
NP6LUSV4Px Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style) 335 mm
(13.2 in.)
2.25 m2
NP7LUSV4Px Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style) 584 mm
(23.5 in.)
4.5 m2
NP8LUSV4Px Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style) 834 mm
(32.8 in.)
6.75 m2
NT6USV4Px Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (T-Style) 349 mm
(13.7 in.)
2.25 m2
NT7USV4Px Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (T-Style) 598 mm
(23.5 in.)
4.5 m2
NT8USV4Px Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (T-Style) 848 mm
(33.4 in.)
6.75 m2
 
3 x = Add additional code for desired connection option, see ‘Connection Options’ table below.

Connection Options

 
Connection Type Applicable Product(s) Code
1 – 112 in. sanitary flange
inlet and outlet
In-Line Style and T-Style 1
1 – 112 in. sanitary flange inlet and 13 mm (12 in.) single barb hose barb outlet In-Line Style only 16
1 – 112 in. sanitary flange inlet and 25 mm (1 in.) single barb hose barb outlet In-Line Style and T-Style 19
 
Application
Filters - Plasma and High-Fouling mAb
Segment
Viral Clearance