pall,颇尔,Pegasus 级 LV6 除病毒滤芯,

产品名称:
Pegasus 级 LV6 除病毒滤芯
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产品介绍

pall,颇尔,Pegasus 级 LV6 除病毒滤芯,
pall,颇尔,Pegasus 级 LV6 除病毒滤芯

Pegasus 级 LV6 除病毒滤芯

Large Virus Removal Filter with High Flow Performance

The risk of large virus contamination is a common feature of biologic products.Potential sources of large virus contamination (retroviruses, for example) of biotechnology
products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the cell line or product during the production process (adventitious viruses).

Large viruses like HIV could potentially be present in donations for plasma derivatives.Pegasus Grade LV6 AB-style Filter Cartridges with Ultipleat® construction
provide an efficient and economical method for removing large viruses like Retroviruses with > 6 log titer reduction or larger virus antibody complexes from biological solutions.The unique Pegasus LV6 membrane in combination with the patented Ultipleat filter construction provides robust high flow rates and total throughput performance which minimizes process costs.The high filter area per filter cartridge reduces the required amount of filter elements per installation and minimizes the hold up volume of the virus filter system.The proven hydrophilic PVDF microporous membrane enables high transmission of proteins also for larger proteins.The filter is delivered pre-sterilized and prewetted which reduces handling time.

特色及优点

 

  • Robust virus retention
  • > 6 log TR for large viruses
  • High flow rate and total throughput performance
  • High filter area per filter cartridge
  • Less filter elements per installation and minimized virus system hold up volume
  • Low binding for high protein yields
  • High protein transmission
  • Pre-sterilized and pre-wetted easy to use
  • SIP and CIP able
  • 100% integrity tested (correlated to virus retention)
  • Manufactured for use in conformance with cGMP
  • Pharmaceutical P-optimized with Certificate of Test provided
  • Validation Guide available

High Quality Standards

 

  • Non-Fiber-Releasing per 21 CFR
  • Meets USP Biological Reactivity, in vivo, for Class VI-121 °C plastics
  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
  • Meets Total Organic Carbon and Conductivity per USP Purified Water, pH per USP packaged waters
 
 

材料成分

 

 
Acrylate-modified polyvinylidene fluoride (PVDF) 
Membrane Support and Drainage Layers Polyethylene/polypropylene
Core and Endcaps  聚丙烯 
Filter Cage  Polypropylene with encapsulated reinforcing ring
O 型圈 Ethylene propylene 
 

 

Operating Conditions

 

 
Recommended Operating Differential Pressure  1 – 2 bar (14.5 – 29 psi differential) 
Maximum Differential Pressure

4.1 bar (60 psi) during integrity testing

3.1 bar (45 psi) for continuous service

0.3 bar (5 psi) during steam sterilization

 

 

Autoclave/Steaming¹

 

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

 

Typical Aqueous Extractables (NVR)

 

 
Out of Box, T0  Average 32 mg, Standard Deviation 3.6 mg 
 After autoclaving at 125 °C ± 5 °C  Average 56 mg, Standard Deviation 3.6 mg
 

 

Filter Area (Nominal)

 

 
1.65 m² (17.8 ft²) per 254 mm (10 in.) element  
 

 

Flow Rate/Differential Pressure

 

 
12 L/min per 254 mm (10 in.) module Water Flow Rate at 2.1 bar (30 psi) differential pressure
 

 

Forward Flow Integrity Test²

 

 
Diffusional flow integrity test, carried out by standard upstream or downstream methods  
Correlated to > 6 log TR for 53 – 82nm PR772 phage³  
Test Wetting Fluid  水 
Test Pressure   4.150 bar (60 psi) (air test gas)†
 
² Contact 颇尔 for cartridge values and correlation data.Validation Guide available on request.Water or buffer-wet values for installation confirmation can also be provided
³ The Parenteral Drug Association virus filter task force has chosen PR772 as the model bacteriophage to standardize nomenclature for large-pore-size virus-retentive filters
† Bar value rounded up to nearest 0.025 bar

 

Process Scale-up with Pegasus Grade LV6 Virus Filters

 

 
Part Number Filter Area
FTKLV6 Filter Discs 11.1 cm² (0.012 ft²) 
   
 AB( )ULV67PJ 1.65 m (17.8 ft²) per 254 mm (10 in.)
 
Length Code:1 = 254 mm (10 in.), 2 = 508 mm (20 in.), 3 = 762 mm (30 in.)

 

Other 颇尔 Direct Flow Virus Filters and Prefilters with Hydrophilic PVDF membrane

 

 
Membrane Type 描述
UDV50 > 6 Log TR for viruses > 50 nm
DV20  > 3 Log TR for viruses > 20 nm
DVD  Sub 0.1 μm virus prefilter
DJL 0.1 μm (+ 0.2 μm prefilter layer)
DFL  0.2 μm (double-layer)
DBL  0.45 μm (+ 0.65 μm prefilter layer) 
 

 


pall,颇尔,Pegasus 级 LV6 除病毒滤芯
上一条pall,颇尔,PCY 聚丙烯滤壳,
下一条pall,颇尔,Pegasus SV4 除病毒滤芯,AB1USV47PH4, AB2USV47PH4, AB3USV47PH4

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