pall,颇尔,Ultipor VF 级 UDV20 除病毒过滤器滤芯,AB1UDV207PH4, AB2UDV207PH4, AB3UDV207PH4

产品名称:
Ultipor VF 级 UDV20 除病毒过滤器滤芯
产品型号:
AB1UDV207PH4, AB2UDV207PH4, AB3UDV207PH4
产品描述:

产品介绍

pall,颇尔,Ultipor VF 级 UDV20 除病毒过滤器滤芯,AB1UDV207PH4, AB2UDV207PH4, AB3UDV207PH4
pall,颇尔,Ultipor VF 级 UDV20 除病毒过滤器滤芯

Ultipor VF 级 UDV20 除病毒过滤器滤芯

Robust, Small-Virus Removal Filter with consistent, High Flow Performance

The risk of virus contamination is ever-present 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 cell line or product during from culture medium or during the production process (adventitious viruses).Viruses could potentially be present in donations for plasma derivatives.Ultipor® VF UDV20 Virus Removal Filter Cartridges are direct flow filters that provide an efficient and economical method for removing even the smallest viruses from biological solutions and meet the acceptance criteria of the Parenteral Drug Association’s virus filter task force for small pore size virus-retentive filters.

特点

  • 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

优势

  • 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

Robustness and Resistance To Plugging

Ultipor VF UDV20 filter cartridges are characterized by robust and stable high performance, over a wide range of process conditions.The innovative hydrophilic PVDF membrane provides stable pressure/flux capabilities also in more complex or concentrated feeds.The unique, patented laid-over pleating technology provides 2x increased effective filtration area.This allows economical virus filtration of high concentrated protein solutions, without product dilution.Flow decay due to membrane plugging and gel polarization is minimized for a wide range of different process conditions and over long process times, which qualifies Ultipor VF UDV20 filters as platform technology.

High Area-Per-Filter-Cartridge

The Ultipor VF UDV20 filter is an extension to the Ultipor VF Grade DV20 virus filter line.The high-filter-area-per-filter cartridge (due to its unique, patented laid-over pleating construction and narrow core) maximizes process productivity, reduces process costs and reduces the required amount of filter elements per installation, which minimizes the hold up volume of the virus filter system.

自动化系统

颇尔 offers fully-automated virus filtration systems that enable precise and consistent operation, together with improved process efficiency.The systems can be designed with steam sterilization (SIP), automated cleaning (CIP) and integrity test in place (ITIP).The Cluster-Filtration Technology assures maximum filter integrity sensitivity.颇尔's fully automated virus filtration systems ensures the highest level of manufacturing safety and process performance.

Rigorous Quality Testing

  • 100% Integrity tested – correlated to PP7 bacteriophage removal
  • PP7 bacteriophage lot release test
  • 100% water flow test
  • Protein transmission test
  • Visual inspection control
  • Quality Control at Multiple Production Stages
  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
  • Meets Total Organic Carbon and Conductivity per USP Purified Water; pH per Sterile Purified Water

已发表文章

 海报:Scalability of Ultipor® VF DV20 and UDV20 Virus Removal Cartridges (PDF, 100 kb)
 
 

材料成分

 
Hydrophilic modified polyvinylidene fluoride (PVDF)
Support and Drainage Layers 聚酯
Core, Cage and Endcaps 聚丙烯
Code 7 adapter Polypropylene with encapsulated stainless steel reinforcing ring
O 型圈 Silicone
 

 

Operating Conditions


 

 
Recommended Operating Delta P 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/Steaming ¹

 
Autoclavable or steamable in-situ Up to 3 cycles 
Maximum Temperature 125 °C
 
¹ Contact 颇尔 for recommended procedures to qualify filters under actual conditions of use

Removal Rating

 
Small viruses ² ≥ 3 Log TR³
Large viruses ≥ 6 Log TR4
 
² Claims based on challenge with parovirus model bacteriophage (bacterial virus) PP7
³ > 4 LRV for PP7 bacteriophage per Parenteral Drug Association (PDA) TR 41 rating method for small virus-retentive filters.> 4 LRV typically with mammalian parvoviruses.
4 Claim based on challenge on retrovirus model bacteriophage PR772 – ≥ 6 LRV typically also with mammalian retroviruses


Typical Aqueous Extractables (NVR)

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

Filter Area (nominal)

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

Forward Flow Integrity Test 5

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

Typical Parvovirus Reduction by Ultipor VF UDV20 Virus Removal Filter Cartridges

 

 

类型

Log Reduction Value:
PPV

Log Reduction Value:
MMV

Log Reduction Value:
B19

mAb 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

-

-

 
PPV = Porcine parvovirus
MMV = Mouse Minute virus
B19 = Human parvovirus

 

Effective Reduction of Large Viruses by Ultipor VF UDV20 Virus Removal Filter Cartridges


 

类型

Log Reduction Value:
HIV

Log Reduction Value:
BVDV

Log Reduction Value:
X-MuLV

Log Reduction Value:
A-MuLV

mAb 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

   
 
X-MuLV = Xenotropic Murine Leukemia virus
A-MuLV = Amphotropic Murine Leukaemia virus
HIV = Human immunodeficiency virus
BVDV = Bovine Viral Diarrhea virus
 

Process Scale-up with Ultipor VF Grade DV20 Virus Filters

 

 
Filter Format Part Number Nominal Filtration Area
Minidisc Capsule 10MCFDV20 0.00096 m²
47mm Disc in FTK200 Holder FTKDV20047 0.0011 m²
Novasip™ Capsule CLM05DV20P1G 0.07 m²
10 in.Fanpleat AB1DV207PH4 1 m²
10 in.Laid-over Pleat AB1UDV207PH4 2 m²
 
See also 颇尔 publication USTR 2612:‘Scalability of Ultipor® VF Grade DV20 and UDV20 Virus Removal Filter Cartridges’

 

 
描述 Part Number
254 mm (10 in.) cartridge, double 226 O-ring adapter with bayonet lock and finned end, seal material silicone elastomer AB1UDV207PH4
508 mm (20 in.) cartridge, double 226 O-ring adapter with bayonet lock and finned end, seal material silicone elastomer AB2UDV207PH4
762 mm (30 in.) cartridge, double 226 O-ring adapter with bayonet lock and finned end, seal material silicone elastomer AB3UDV207PH4
 

 


pall,颇尔,Ultipor VF 级 UDV20 除病毒过滤器滤芯
上一条pall,颇尔,Ultroser 血清替代物,15950-017
下一条pall,颇尔,Ultipor VF 级 DV50 病毒清除过滤器滤芯,

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