pall,颇尔,Ultipor VF 级 DV20 病毒清除过滤器滤芯,

产品名称:
Ultipor VF 级 DV20 病毒清除过滤器滤芯
产品型号:
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产品介绍

pall,颇尔,Ultipor VF 级 DV20 病毒清除过滤器滤芯,
pall,颇尔,Ultipor VF 级 DV20 病毒清除过滤器滤芯

Ultipor VF 级 DV20 病毒清除过滤器滤芯

Integrity testable, direct flow filters for size exclusion removal of viruses

Ultipor® VF Grade DV20 Virus Removal Filter cartridges are suitable for size exclusion removal of viruses as small as 20 nm from biological solutions. The innovative, DV20 hydrophilic PVDF microporous membrane also enables > 95% transmission of proteins up to 160 kiloDaltons.Using a standard single open-ended (SOE) AB sanitary style cartridge design, Ultipor VF Grade DV20 Virus Removal filters achieve practical flows and pressure drops in process-scale purification of biopharmaceuticals, tissue and plasma derivatives and protein additives.Where required, suitable prefilters employing the same PVDF membrane material are available, simplifying process optimization and filtration system validation.

特色及优点

 

  • Sanitary direct flow cartridges
  • Robust size exclusion mechanism
  • ≥ 3 log TR for > 20 nm viruses
  • ≥ 6 log TR for > 50 nm viruses
  • Low binding for high protein yields
  • High transmission of albumin and IgG
  • Very low extractables
  • Autoclavable and Steamable in situ (SIP)
  • 100% integrity-tested (correlated to virus retention)
  • Manufactured for use in conformance with cGMP
  • Pharmaceutical P optimized with Certificate of Test provided

Claims are based on challenges with bacteriophage (bacterial viruses) PP7 (25 nm) and PR772 (53 nm) in 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F).

Quality and Bio-Safety Biological Tests

 

Integrity
(正直诚信)

 

  • Every DV20 grade filter integrity tested during manufacture.Test correlated to viral (phage) removal

Biological Tests

 

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

Effluent Quality Tests¹

 

  • Meet 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

Autoclave Resistance

 

  • Lot samples multi-cycle autoclave challenged

¹ Per lot sample or rinse-flush aliquots

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 polyvinylidenefluoride (PVDF)
Support and Drainage  聚酯 
Core, Cage and End Caps  聚丙烯 
Code 7 Adapter  Polypropylene with encapsulated stainless steel reinforcing ring 
O 型圈 Silicone
 

 

Configuration

 

 
Polypropylene with encapsulated stainless steel reinforcing ring 
 

 

Nominal Dimensions

 

 
Length 10 in. (254 mm), 20 in. (508 mm), 30 in. (762 mm), 40 in. (1016 mm) 
Diameter 70 mm (2.75 in.)
 

 

Operating Conditions

 

 
Recommended Operating ∆P  1 – 2 bard (15 – 29 psid) 
Maximum Differential Pressures      6.0 bard (90 psid) during integrity testing
3.1 bard (45 psid) for continuous service
 

 

Nominal Filter Area

 

 
1.0 m² (10.8 ft²) per 10 in. (254 mm) element 
 

 

Aqueous Extractables (NVR)

 

 
< 5 mg per 10 in. (254 mm) element in deionized water at 20 °C (68 °F), process-ready (after integrity testing in 30% IPA/water, water flush and autoclaving) 
 

 

Autoclave and Steaming In Situ¹

 

 
Maximum Temperature 125 °C (257 °F) 
 
¹ Contact 颇尔 for recommended procedures to qualify filters under actual conditions of use

 

Typical Liquid Flow Rate²

 

 
15 L/h/10 in. (254 mm) module at 30 psid for 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F) 
 
² Claims based on challenges with bacteriophage (bacterial viruses) PP7 (25 nm) and PR772 (53 nm) in 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F)

 

Removal Ratings

 

 
3 Log TR for viruses > 20 nm
6 Log TR for viruses > 50 nm 
 

 


pall,颇尔,Ultipor VF 级 DV20 病毒清除过滤器滤芯
上一条pall,颇尔,Ultipor VF Grade DV20 Virus Removal Filter Membrane in Minidisc Capsules,10MCFDV20
下一条pall,颇尔,Ultipor VF Grade DV20 and DV50 Virus Removal Filter Membrane in Novasip Capsules,CLM05DV20P1G, CL3DV50P1G

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