pall,颇尔,Ultipor VF 级 DV50 除病毒过滤器滤芯 – SBF Junior,SBF1DV50PH4

产品名称:
Ultipor VF 级 DV50 除病毒过滤器滤芯 – SBF Junior
产品型号:
SBF1DV50PH4
产品描述:

产品介绍

pall,颇尔,Ultipor VF 级 DV50 除病毒过滤器滤芯 – SBF Junior,SBF1DV50PH4
pall,颇尔,Ultipor VF 级 DV50 除病毒过滤器滤芯 – SBF Junior

Ultipor VF 级 DV50 除病毒过滤器<a href='http://pall.net.cn/' target='_blank'>滤芯</a> – SBF Junior
Ultipor VF Grade DV50 virus removal filters are a robust means to remove viruses from liquids by microfiltration, while permitting enhanced transmission of proteins.SBF 小型折叠膜迷你滤芯设计用于小规模认证和验证研究,以及用于高达 10 – 20 升的小工艺批次。Typical applications for these easy-to-use direct flow filters include purification of biopharmaceuticals, plasmaderivatives, protein or serum containing cell-culture media and diagnostic reagents.

 

特色及优点

 

  • 6 log Titer Reduction (TR) for 50 nm viruses
  • Robust size exclusion mechanism
  • Narrow pore-size distribution
  • Easy-to-validate direct flow use
  • Linear scale-up to larger batches
  • 低蛋白结合率
  • Low filter extractables
  • 100% integrity-tested
  • Pre-use testable with WFI
  • Manufactured for use in conformance with cGMP
  • ISO 9000 Certified Quality System
  • Pharmaceutical P optimized
  • Certificate of Test provided
  • Validation Guide available

SBF style also available with 0.2 µm Ultipor® N66, Bio-Inert®, Posidyne®, Fluorodyne® II and Emflon® II media

Quality and Bio-Safety Biological Tests

 

  • Integrity (100% Unit Release Test)
  • Correlated to viral (phage) retention

Biological Tests

 

  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics

Effluent Quality Tests*

 

  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing per 21 CFR
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water; pH per Sterile Purified Water

Autoclave Resistance

Lot samples multi-cycle autoclave challenged
* Per lot samples soak or rinse-up flush aliquots

 
 

材料成分

 

 
膜  Hydrophilic low protein binding polyvinylidenefluoride (PVDF) 
Support and Drainage       聚酯 
Core, Cage and End Caps       聚丙烯 
O-ring     Silicone¹
 
¹ Other polymers available

 

Virus Removal Ratings²

 

 
TR ≥ 106 for viruses ≥ 50 nm 
 
² Lot samples retain log 106 TR of 53 nm spherical non-enveloped bacteriophage PR772

 

Nominal Filter Area

 

 
0.074 m² (0.8 ft²) 
 

 

Nominal Dimensions

 

 
Length    62 mm (2.4 in.) 
Diameter 43 mm (1.7 in.)
 

 

Configuration

 

 
Single open-ended cartridge, sanitary style plug adapter, double 116 O-ring
 

 

Autoclave and Steaming in situ³

 

 
Autoclavable at 125 °C
 
³ Contact 颇尔 for recommended procedures

 

Operating Conditions

 

 
Maximum Differential Pressure*  3 bard (43.5 psid) 
Recommended Operating Pressure     1 - 2 bard (15 – 29 psid) 
Maximum Differential Pressure for Integrity Test Performance (Short-term)     6.0 bard (90 psid)
 
* Viral TR pressure-independent

 

Aqueous Extractables (NVR)

 

 
1 mg per element in deionized water at 20 – 25 °C after autoclaving 
 

 

 
Part Number
SBF1DV50PH4* 
 
* H4 suffix = Silicone O-rings (standard).Ethylene Propylene and Fluoropolymer Elastomer O-rings available.P in part number indicates optimized and qualified for pharmaceutical use including 100% integrity test and Certificate of Test.

注意事项:For suggested qualification protocols, test and validation discs, sizing and sterilizing recommendations, SBF style cartridges with 0.2 µm or other grade, please contact 上海羽令.

 


pall,颇尔,Ultipor VF 级 DV50 除病毒过滤器滤芯 – SBF Junior
上一条pall,颇尔,Ultipor VF 级 DV50 病毒清除过滤器滤芯,
下一条pall,颇尔,Ultipor VF Grade DV20 Virus Removal Filter Membrane in Minidisc Capsules,10MCFDV20

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