pall,颇尔,配Fluorodyne II DFL 膜的Kleenpak Nova囊式过滤器,

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配Fluorodyne II DFL 膜的Kleenpak Nova囊式过滤器
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pall,颇尔,配Fluorodyne II DFL 膜的Kleenpak Nova囊式过滤器,
pall,颇尔,配Fluorodyne II DFL 膜的Kleenpak Nova囊式过滤器

配Fluorodyne II DFL 膜的Kleenpak Nova囊式过滤器
These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption.They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.

Kleenpak Nova 囊式过滤器专为中等至大规模(100 升至 1000 升以上)生产环境应用而设计,通常使用较小 Kleenpak 囊式过滤器型号进行规模研究之后的终端用户会选择使用这类过滤器。Kleenpak Nova 囊式过滤器通常可提供使用清洁型法兰或软管倒钩配件的“在线型”(NP) 或“T”型 (NT) 入口/出口配置。With the AB-style filter cartridge at their core, Kleenpak Nova filter capsules can be supplied with the most comprehensive range of filter media among all of 颇尔’s single-use capsules.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Incorporated prefiltration layer
  • Low extractables  
  • High protein transmission
  • Rapid preservative recoveries 
  • Easy integrity testing 
  • Compatible with organic solvents, acids and chemicals¹
  • 不含树脂和表面活性剂 
  • Melt-sealed, non shedding
    ¹ Except ketones and amides

Quality Standards

  • Manufactured for use in conformance with cGMP 
  • 100% integrity tested
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Every filter tested during manufacture
  • Test correlated to microbial retention
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention
    • 材料成分
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
 
 

材料成分

 
Filter Membrane  Hydrophilic modified PVDF
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  聚丙烯
 
¹ TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters²

 
 Maximum Temperature 40 °C
 最大操作压力 3 bar (44 psi) at 40 °C
 Maximum Differential Pressure (Forward Direction) 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

 
 Autoclavable (G option only)  3 x 60 minutes at 125 °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 °C*

 
G option  < 10 mg per 254 mm (10 in.) capsule
S option  < 20 mg per 254 mm (10 in.) capsule
 
* Tested on elements without pre-flushing


Nominal Dimensions


 
同轴的  NP5 NP6 NP7 NP8
Maximum diameter including valves 154 mm
(6.1 in.)
154 mm
(6.1 in.)
154 mm
(6.1 in.)
154 mm
(6.1 in.)
Length with hose barb inlet/outlet 275 mm
(10.8 in.)
397 mm
(15.6 in.)

644 mm
(25.4 in.)

895 mm
(35.2 in.)
Length with sanitary inlet/outlet 213 mm
(8.4 in.)
335 mm
(13.2 in.)

584 mm
(23.0 in.)

834 mm
(32.8 in.)
T-style   NT6 NT7 NT8
Maximum diameter including valves 不可用 240 mm
(9.5 in.)
240 mm
(9.5 in.)
240 mm
(9.5 in.)
 Length 不可用  349 mm
(13.7 in.)
598 mm
(23.5 in.)
848 mm
(33.4 in.)
 

 

Nominal Effective Filter Area (EFA)

 

5500 cm² per 254 mm capsule (5.9 ft² per 10 in. capsule)

 

 

Integrity Test Values (Air test gas, water wet)**

 
 Max. allowable forward flow values for
254 mm (10 in.) capsule at 20ºC 
12 mL/min at 2760 mbar (40 psi)
 
** Contact 颇尔 for multi-element integrity test values and recommended test procedures



pall,颇尔,配Fluorodyne II DFL 膜的Kleenpak Nova囊式过滤器
上一条pall,颇尔,配 Fluorodyne II DFL 膜的Kleenpak囊式过滤器,
下一条pall,颇尔,配Fluorodyne II DFL 膜的小型Kleenpak 20 囊式过滤器 ,KM5DFLP2S

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