pall,颇尔,配Fluorodyne II DFL 膜的小型 Kleenpak 20 囊式过滤器,

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配Fluorodyne II DFL 膜的小型 Kleenpak 20 囊式过滤器
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pall,颇尔,配Fluorodyne II DFL 膜的小型 Kleenpak 20 囊式过滤器,
pall,颇尔,配Fluorodyne II DFL 膜的小型 Kleenpak 20 囊式过滤器

配Fluorodyne II DFL 膜的小型 Kleenpak 20 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.

Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.

Key Features and Benefits

  • Ideal for screening trials
  • Highest flow of  PVDF 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 
    • Material of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
 
 

材料成分

 
Filter Membrane Hydrophilic modified PVDF
Housing, Vent Plug and Support Material Polypropylene (Filling Bell is polycarbonate)
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters¹


 
Maximum Operating Temperature and Pressure 1.4 bar (20 psi) at 20 °C
 
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction


Sterilization²


 
Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation
 
² Pre-sterilized Mini Kleenpak 20 capsules must not be re-sterilized.Mini Kleenpak 20 capsules must not be sterilized in-situ by passing steam under pressure

Typical Hold up Volume


 
< 2.5 毫升 
 


Nominal Dimensions


 
Capsule Length 83 mm (3.3 in.)
Capsule Diameter 67 mm (2.7 in.)
 

Nominal Effective Filter Area (EFA)


 
20 cm² (3.1 in.²)
 


连接


 
¼ – ½ in. (6 – 13 mm) stepped hose barb.Inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet
 


 
项目 Part Number
配Fluorodyne II DFL 膜的小型 Kleenpak 20 囊式过滤器 KM5DFLP2S*
 

* supplied as 1 box of 3 filters

 


pall,颇尔,配Fluorodyne II DFL 膜的小型 Kleenpak 20 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,KM5DJLP2S
下一条pall,颇尔,配Fluorodyne EX EDF 膜的小型 Kleenpak 20 囊式过滤器,KM5EDFP2S

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