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

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配 Fluorodyne II DJL 膜的Kleenpak囊式过滤器
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产品介绍

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

配 Fluorodyne II DJL 膜的Kleenpak囊式过滤器
These 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction assure high flow rates compared with other 0.1 micron (and even some 0.2 micron)-rated filters.Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical TR >108 and retention of Brevundimonas diminuta (ATCC 19146) at 107CFU/cm² effective filter area (EFA).This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

Kleenpak 囊式过滤器坚固耐用且体积小巧,可提供多种过滤介质,并有 4 种过滤面积尺寸以满足小型到大型的规模制药生产环境中的多种应用需求(容量为 30 升至 1000 升)。These in-line single-use assemblies are available with sanitary or hose barb inlet/outlet fittings.

Key Features and Benefits

    • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
    • Built in prefiltration
    • Minimal hold up volume
    • 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 
    • Material of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
 
 

材料成分

 
Filter Membrane Hydrophilic modified PVDF

Support/Drainage
End Cap, Core and Cage
囊式过滤器

聚丙烯
聚丙烯
聚丙烯
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters¹

 
Maximum Operating Temperature  40 °C 
最大操作压力 5.2 bar (75 psi) at 20 °C
4.0 bar (58 psi) at 40 °C
Maximum Differential Pressure (Forward Direction) 4.0 bar (58 psi) at 40 °C
 
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction


Sterilization²

 
Autoclave (G and blank option only)  30 x 60 minutes at 125 °C
10 x 60 minutes at 140 °C
Gamma Irradiation (G option only) Maximum of 50 kGy
 
² Pre-sterilized Kleenpak capsules must not be re-sterilized. Kleenpak capsules must not be sterilized in-situ by passing steam under pressure

Typical Extractables in Water at 20 °C³

 
< 5 mg per capsule
 
³ Tested on capsules without pre-flushing

Nominal Dimensions

 
  KA1 KA2 KA3 KA4
Diameter incl.Valves 94 mm (3.7 in.) 94 mm (3.7 in.) 105 mm (4.1 in.) 105 mm (4.1 in.)
Length - Code 1 117 mm (4.6 in.) 157 mm (6.2 in.) 174 mm (6.8 in.) 287 mm (11.3 in.)
Length - Code 2 158 mm (6.2 in.) 198 mm (7.8 in.) - -
Length - Code 6 157 mm (6.2 in.) 197 mm (7.7 in.) 210 mm (8.3 in.) 327 mm (12.8 in.)
Length - Code 12 137 mm (5.4 in.) 177 mm (7.0 in.) -
Length - Code 16 137 mm (5.4 in.) 177 mm (7.0 in.) 192 mm (7.6 in.) 305 mm (12.0 in.)
 

Nominal Effective Filter Area (EFA)

 
KA1 400 cm² (0.4 ft²)
KA2  800 cm² (0.9 ft²)
KA3 1500 cm² (1.6 ft²)
KA4 3300 cm² (3.6 ft²)
 









pall,颇尔,配 Fluorodyne II DJL 膜的Kleenpak囊式过滤器
上一条pall,颇尔,Fluorodyne II DJL Membrane in Junior Filter Cartridges (MCY Style),MCY1110DJLPH4, MCY4440DJLPH4
下一条pall,颇尔,配Fluorodyne II DJL 膜的Kleenpak Nova囊式过滤器,

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