フロロダイン® II DFL ミニ・クリーンパック™ カプセルフィルター product photo Primary L

フロロダイン® II DFL ミニ・クリーンパック™ カプセルフィルター

These validated 0.2 micron-rated sterilizing-grade filters retain Brevundimonas diminuta (ATCC 19146) at 107CFU/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 capsules are used in the laboratory for process development and in pilot and manufacturing scale operations if processing requirements do not demand a large filter (process volumes from 2 L to 50 L). They are the smallest capsule filters with a pleated membrane in Pall’s UpScale 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
  • Resin and surfactant-free 
  • 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


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フィルター KAタイプ product photo
製品ID:
KA02DFLP2S
Removal Rating
0.2 µm
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
200 cm²
Maximum Batch Volume
50 L
Sterilization Option(s)
Provided Pre-Sterilized by Gamma Irradiation
販売単位
EA
最少受注数量
1
価格
Removal Rating
0.2 µm
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
200 cm²
Maximum Batch Volume
50 L
Sterilization Option(s)
Suitable for Gamma Irradiation
販売単位
PAC
最少受注数量
1
価格
  • «

Capsules

カタログ・技術資料

シリーズカタログ

ダウンロード: 英語

概要

These validated 0.2 micron-rated sterilizing-grade filters retain Brevundimonas diminuta (ATCC 19146) at 107CFU/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 capsules are used in the laboratory for process development and in pilot and manufacturing scale operations if processing requirements do not demand a large filter (process volumes from 2 L to 50 L). They are the smallest capsule filters with a pleated membrane in Pall’s UpScale 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
  • Resin and surfactant-free 
  • 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

仕様

Materials Of Construction

 
Filter Membrane Hydrophilic modified PVDF

Support/Drainage
Capsule Shell
Filling Bell

Polypropylene
Polypropylene
Polycarbonate
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters¹

 
Maximum Operating Temperature  40 °C 
Maximum Operating Pressure 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)
 


製品カテゴリー

カプセルフィルター

型式

 
Part Number Description
KA02DFLP2G 0.2 micron sterilizing grade and mycoplasma control, ¼ - ½ in. (6-13 mm) hosebarb, Non-sterile, Gamma irradiatable/autoclavable
KA02DFLP2S 0.2 micron sterilizing grade and mycoplasma control, ¼ - ½ in. (6-13 mm) hosebarb, Pre-sterilized using gamma irradiation
KA02DFLP8G 0.2 micron sterilizing grade and mycoplasma control, ½ - ¾ in. (13-19 mm) sanitary flange, Gamma irradiatable/autoclavable
KA02DFLP8S 0.2 micron sterilizing grade and mycoplasma control, ½ - ¾ in. (13-19 mm) sanitary flange, Pre-sterilized using gamma irradiation
 

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