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

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

配Fluorodyne II DJL 膜的小型 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 >1011 and retention of Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA).This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

若无大型过滤器(工艺容量 2 升至 50 升)工艺要求,则小型 Kleenpak 囊式过滤器可用于实验室工艺开发和中试级生产规模运营。They are the smallest capsule filters with a pleated membrane in 颇尔’s UpScale range and are excellent for modeling filter performance at large production scale

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Minimal hold up volume
  • Ideal for scale-up trials
  • Highest flow of comparable PVDF filters
  • 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
囊式过滤器
Filling Bell

聚丙烯
聚丙烯
聚碳酸酯
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters¹

 
Maximum Operating Temperature  40 °C 
最大操作压力 4.1 bar (60 psi) at 40 °C
Maximum Differential Pressure (Forward Direction) 4.1 bar (60 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 option only)  3 x 60 minutes at 125 °C
Gamma Irradiation (G option only) Maximum of 50 kGy
 
² Pre-sterilized Mini Kleenpak capsules must not be re-sterilized. Mini Kleenpak capsules must not be sterilized in-situ by passing steam under pressure

Typical Extractables in Water at 20 °C³

 
G option only  < 1 mg
S option only < 5 mg
 
³ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Nominal Dimensions

 
Maximum diameter including valves  41 mm (1.6 in.)
Length - Code 2 105 mm (4.1 in.)
Length - Code 8 73 mm (2.9 in.)
 

Nominal Effective Filter Area (EFA)

 
200 cm² (0.22 ft²)
 



pall,颇尔,配Fluorodyne II DJL 膜的小型 Kleenpak 囊式过滤器
上一条pall,颇尔,配Fluorodyne II DJL 膜的小型Kleenpak 20 囊式过滤器,
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