Robust, Stable Flowrate Small-Virus Removal Filterwith Consistent, High Capacity Performance

USD 2329a

Features

Incorporates Ultipor VF DV20 virus filter membrane

Proven, reliable virus safety technology

High filtration area per filter cartridge

Robust, stable flowrate

Resistant to plugging

Rigorous quality testing

Autoclavable and Steamable In Place (SIP)

Automatic in-line integrity test

Fully automated systems available

Benefits

Robust, high viral clearance for small viruses

Approved for use in licensed processes

Maximizes process productivity, reduces Cost of Goods

Stable flux rates achievable in a wide range of process conditions. Consistent performance (suitable for platform technology)

Minimized flux decay

Provides assurance of consistent performance per specification

Enables a sterile process where required

Reduces labor costs, minimizes risk of handling errors

Enables the highest level of process control and safety

Ultipor VF UDV20 Virus Removal Filter Cartridges

DescriptionThe risk of virus contamination is ever-present in biologicproducts. Potential sources of virus contamination of biotechnology products include viruses associated withthe cell lines (endogenous viruses), or viruses introduced intothe cell line or product during from culture medium or duringthe production process (adventitious viruses). Viruses couldpotentially be present in donations for plasma derivatives.

Ultipor VF UDV20 Virus Removal Filter Cartridges are direct flow filters that provide an efficient and economicalmethod for removing even the smallest viruses frombiological solutions.

Table 1Effective Parvovirus Reduction Typical ParvovirusReduction by Ultipor VF UDV20 Filters

Product LRVType PPV MMV B19mAb 1 6.3

mAb 2 6.2

mAb 3 > 5.8

mAb 4 5.1

mAb 5 > 5.8

mAb 6 > 5.0

mAb 7 4.2

hIgG 1 > 4.8

hIgG 2 > 5.0

hIgG 3 > 6.6

Table 2Effective Reduction of Large Viruses by Ultipor VFUDV20 Filters

Product LRVType HIV BVDV X-MuLV A-MuLVmAb 1 > 5.6

mAb 2 > 5.3

mAb 3 > 5.1

mAb 4 > 5.7

mAb 5 > 6.0

mAb 6 > 5.4

mAb 7 > 4.9

mAb 8 > 5.7

mAb 9 > 5.4

mAb 10 > 4.6

hIgG 1 > 5 > 5

hIgG 2 > 6.2 > 5.4

hIgG 3 > 5 > 4.6

hIgG 4 > 4.6 > 6.1

Ultipor VF UDV20 filters meet the acceptance criteria of theParenteral Drug Associations virus filter task force for small-pore-size virus-retentive filters.

Ultipor VF UDV20 filter cartridges are characterized byrobust and stable high performance, over a wide range ofprocess conditions. The innovative hydrophilic PVDFmembrane provides stable pressure/flux capabilities also in more complex or concentrated feeds. The unique,patented laid-over pleating technology provides 2xincreased effective filtration area.

This allows economical virus filtration of high concentratedprotein solutions, without product dilution. Flow decay dueto membrane plugging and gel polarization is minimized fora wide range of different process conditions and over longprocess times, which qualifies Ultipor VF UDV20 filters asplatform technology.

Figure 1Resistance to Plugging Fouling Fluids

NOTE: Ultipor VF DV20 membrane flux profiles during filtration of serumIgG compared to high initial flow filter which show rapid flow decay incomplex and concentrated fluids.

Due to its robust, stable flow and resistance to pluggingeven at high virus spike concentrations, no dilution of virusspike or exceptional virus spike purification is required,which allows the highest titer reduction claims for MuLV and other viruses.

0

40

80

0 80 160 240 320Protein Throughput (g/m2)

Flu

x (L

h-1 )

per

10

in. C

artr

idg

e

UDV20High Initial Flow Filter A (High Fouling)High Initial Flow Filter B (High Fouling)

Figure 2Resistance to Plugging under Different Virus Spike Preparations

Ultipor VF DV20 membrane flux profiles during duplicate viral challengetests at different virus spike levels. The data are duplicate results fromthree separate monoclonal antibody solutions that required a variety ofvirus spike specifications.

The Ultipor VF UDV20 filter is an extension to the Ultipor VFGrade DV20 virus filter line. The high-filter-area-per-filter-cartridge (due to its unique, patented laid-over pleatingconstruction and narrow core) maximizes processproductivity, reduces process costs and reduces therequired amount of filter elements per installation, whichminimizes the hold up volume of the virus filter system.

Figure 3Pleating Comparison

Pall offers fully-automated virus filtration systems that enableprecise and consistent operation, together with improvedprocess efficiency. The systems can be designed withsteam sterilization (SIP), automated cleaning (CIP) andintegrity test in place (ITIP). The Cluster-Filtration Technologyassures maximum filter integrity sensitivity. Pall fully-automated virus filtration systems ensures the highest levelof manufacturing safety and process performance.

Rigorous Quality Testingu 100% Integrity tested tested correlated to PP7 bacteriophage removal

u PP7 bacteriophage* lot release test

u 100% water flow test

u Protein transmission test

u Visual inspection control

u Quality Control at Multiple Production Stages

High Quality Standards u Meets USP Biological Reactivity Test, in vivo, for Class VI-121 C Plastics

u Meets Cleanliness per USP Particulates in Injectables

u Non-Fiber-Releasing

u Non-Pyrogenic per USP Bacterial Endotoxins(< 0.25 EU/mL)

u Meets Total Organic Carbon and Conductivity per USPPurified Water; pH per Sterile Purified Water

www.pall.com/biopharm

Flu

x

Throughput

5% Spike5% Spike2% Spike2% Spike1% Spike1% Spike

DV20 filter cartridgeshowing fan pleatand standard core

UDV20 filter cartridgeshowing laid-over pleats

and narrow core

Europe+44 (0)23 9230 3303 phone+44 (0)23 9230 2506 faxBioPharmUK@europe.pall.com e-mail

United States800.717.7255 toll free (USA)516.484.5400 phone516.801.9548 faxbiotech@pall.com e-mail

International OfficesPall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria,Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico,the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all majorindustrial areas of the world.

The information provided in this literature was reviewed for accuracy at the time of publication. Product data may besubject to change without notice. For current information consult your local Pall distributor or contact Pall directly.

2010, Pall Corporation. Pall, , Novasip, Ultipor and Ultipleat are trademarks of Pall Corporation. indicates a trademark registered in the USA. Filtration. Separation. Solution.SM is a service mark of PallCorporation.

04/10, PDF, UK GN10.3609 USD 2329a

Visit us on the Web at www.pall.com/biopharme-mail us at biotech@pall.com

Technical Specifications

Materials of Construction

Membrane Hydrophilic modified polyvinylidenedifluoride (PVDF)

Support and Drainage Layers Polyester

Core, Cage and Endcaps Polypropylene

Code 7 adapter Polypropylene with encapsulated stainless steel reinforcing ring

O-rings Silicone

Operating Conditions

Recommended Operating DP 1 to 3.1 bard (14.5 to 45 psid)

Maximum Differential Pressure 3.1 bar (45 psi) for continuous service, 0.3 bar (5 psi) during steam sterilization, 6.2 bar (90 psi) during integrity testing

Autoclave/steaming1

Autoclavable or steamable in-situ for up to 3 cycles

Maximum Temperature 125 C 1 Contact Pall for recommended procedures to qualify filters under actual conditions of use.

Removal Rating

Small viruses2 3 Log TR3

Large viruses 6 Log TR42 Claims based on challenge with parovirus model bacteriophage (bacterial virus) PP73 > 4 LRV for PP7 bacteriophage per Parenteral Drug Association (PDA) TR 41 rating method forsmall virus-retentive filters. > 4 LRV typically with mammalian parvoviruses.

4 Claim based on challenge on retrovirus model bacteriophage PR772 6 LRV typically alsowith mammalian retroviruses

Typical Aqueous Extractables (NVR)

< 15 mg per 254 mm (10 in) element, process-ready (after integritytesting, water flush and autoclaving)

Filter Area (nominal)

2 m2 (22 ft2) per 254 mm (10 in.) element

Forward Flow Integrity Test5

Diffusional flow integrity test, carried out by standard upstream ordownstream methods5 Correlated to > 3 log TR for 25 nm PP7 phage and > 6 log TR for 53 nm PR772 phage

Table 3Process Scale-up with Pall Ultipor VF Grade DV20 Virus Filters

Nominal Filter Format Part Number Filtration Area

Minidisc Capsule 10MCFDV20 0.00096 m2

47mm Disc FTKDV20047 0.0011 m2

in FTK200 Holder

Novasip Capsule CLM05DV20P1G 0.07 m2

10 in. Fanpleat AB1DV207PH4 1 m2

10 in. Laid-over Pleat AB1UDV207PH4 2 m2

See also Pall publication USTR 2612: Scalability of Ultipor VF Grade DV20 and UDV20 VirusRemoval Filter Cartridges

Ordering Information

Removal Rating 3 Log TR for viruses > 20 nm

6 Log TR for viruses > 50 nm

Nominal Length 254 mm (10 in.)

508 mm (20 in.)

762 mm (30 in.)

Code1

2

3

Adapter StyleDouble 226 O-ring with bayonetlock and finned end

Seal MaterialSilicone elastomer

Pall Part Number: AB UDV20 7 P H4

Specifications and Availability: The information provided is a guide to the part number structure and possible options. Product availability may be subjectto change without notice. All specifications are nominal. The literature was reviewed for accuracy at the time of publication. For additional information, con-sult your local Pall distributor.