pall,颇尔,配Supor EAV 膜的 Kleenpak Nova 囊式过滤器,

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配Supor EAV 膜的 Kleenpak Nova 囊式过滤器
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产品介绍

pall,颇尔,配Supor EAV 膜的 Kleenpak Nova 囊式过滤器,
pall,颇尔,配Supor EAV 膜的 Kleenpak Nova 囊式过滤器

配Supor® EAV 膜的 Kleenpak™ Nova 囊式过滤器
Supor® grade EAV membrane filters are designed for effective bioburden and particle control of buffers and pharmaceutical or biological process fluids.A highly asymmetric single layer membrane incorporated in these filters ensures high throughputs and flow rates when utilized for the protection of downstream chromatography columns, ultrafilters or sterilizing filters.

Supor grade EAV membrane filters allow for reduced sizing of filter systems with improved process efficiencies when use of validated sterilizing grade filters is not essential, but reliable bioburden control is required. Supor grade EAV membrane filters are also effective prefilters for protection and extending the life of 0.2 µm sterilizing-grade and finer membrane filters where required.

颇尔’s range of Kleenpak™ Nova capsules are designed for use in medium to large scale production environments (100 L > 1000 L), often selected by the end user following scaling studies using smaller Kleenpak capsule formats.With the AB style cartridge format at its core, this capsule filter style can be supplied with the most comprehensive range of filter media.

特色及优点

  • Hydrophilic, controlled asymmetric polyethersulfone (PES) membrane ensures high microbial and particulate reduction with outstanding service life
  • Bacterial titer reduction in excess of 6 log for Brevundimonas diminuta ensures low bioburden levels in filtrate, regardless of bacteria or particle loading
  • pH 兼容性广,可处理多种缓冲液和流体
  • High membrane area featuring 颇尔-patented cresent-shaped laid-over pleat construction combined with a narrow diameter core guarantees high flow rates, robustness and smaller multi-cartridge assemblies
  • Kleenpak™ capsule formats eliminate housing cleaning and associated validation, for ease of use and integration into Allegro single-use disposable systems
  • Low-binding polyethersulfone membrane for maximum transmission of proteins

Quality Standards

  • 100% integrity tested
  • Manufactured for use in conformance with cGMP
  • Each filter is fully traceable by individual marked lot and serial number
  • Manufactured under an ISO 9001 Certified Quality System
  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
  • Certificate of Test provided confirms:
    • Fabrication Integrity 
    • Bacterial Retention 
    • Materials of construction
    • Effluent quality for cleanliness, TOC, water conductivity, pH and pyrogens
       
 
 

材料成分

 
Filter Membrane  Hydrophilic asymmetric PES 
Support/Drainage 聚丙烯
Core/End Caps 聚丙烯
Cage Polypropylene with TiO2 whitener¹
O 型圈 Silicone elastomer
Sealing Technology Thermal bonding without adhesives
Housing Bowl 聚丙烯
Housing Head Polypropylene with TiO2 whitener
 
¹ TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

 

Operating Parameters²

 
Maximum Operating Temperature  40 °C
最大操作压力 3 bar (44 psi) at 40 °C
Maximum Differential Pressure 3 bar (44 psi) at 40 °C
 
² In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

 

Sterilization³

 
Autoclave (G option only)  1 x 60 minutes at 135 °C
Gamma irradiation (G option only) Maximum of 50 kGy
 
³ Pre-sterilized Kleenpak Nova capsules must not be re-sterilized.Kleenpak Nova capsules must not be sterilized in-situ by passing steam under pressure

 

Typical Extractables in Water at 20 °C4

 
< 50 mg per 254 mm (10 in.) module 
 
4 Tested on elements without pre-flushing

 

Nominal Effective Filter Area (EFA)

 
1.06 m2 per 254 mm module (11.4 ft2 per 10 in. module) 
 

 

Integrity Test Values (air test gas, water wet)5

 
Max. allowable Forward Flow Water wet 50 mL/min at 2060 mbar (30 psi)
 
5 Values for 254 mm (10 in.) filter at 20°C.Contact 颇尔 for multi-element integrity test values and recommended test procedures

 

Nominal Dimensions

 
同轴的 NP6 NP7 NP8
Maximum Diameter including valves 154 mm (6.1 in.) 154 mm (6.1 in.) 154 mm (6.1 in.)
Length with hose barb inlet/outlet 397 mm (15.6 in.) 644 mm (25.4 in.) 895 mm (35.2 in.)
Length with sanitary inlet/outlet 335 mm (13.2 in.) 584 mm (23.0 in.) 834 mm (32.8 in.)
T-style NT6 NT7 NT8
Maximum Diameter including valves 240 mm (9.5 in.) 240 mm (9.5 in.) 240 mm (9.5 in.)
Length 349 mm (13.7 in.) 598 mm (23.5 in.) 848 mm (33.4 in.)
 

 

Kleenpak Nova In-line Capsules (NP) Typical Liquid Flow vs.Differential Pressure

 

 

Kleenpak Nova T-Style Capsules (NT) Typical Liquid Flow vs.Differential Pressure


pall,颇尔,配Supor EAV 膜的 Kleenpak Nova 囊式过滤器
上一条pall,颇尔,配Supor EBV 膜的 Kleenpak Nova 囊式过滤器,
下一条pall,颇尔,配Fluorodyne II DJL 膜的 Kleenpak Nova 囊式过滤器,

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