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 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 (T_R) 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 T_R 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