Fluorodyne® II DJL Membrane in Kleenpak™ Nova Capsules product photo Primary L

Fluorodyne® II DJL Membrane in Kleenpak™ Nova Capsules

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.

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (100 L to > 1000 L), and are often selected by the end user following scaling studies using the smaller Kleenpak capsule formats. Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings. 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 Pall’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
  • 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
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens


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Description
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.

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (100 L to > 1000 L), and are often selected by the end user following scaling studies using the smaller Kleenpak capsule formats. Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings. 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 Pall’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
  • 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
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
Specifications

Materials of Construction

Filter Membrane  Hydrophilic modified PVDF
Support/Drainage  Polypropylene
Core/End Caps  Polypropylene
Cage  Polypropylene with TiO2 whitener¹
O-rings  Silicone elastomer
Sealing Technology  Thermal bonding without adhesives
Housing Bowl  Polypropylene
 Housing Head  Polypropylene
¹ TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters²

 Maximum Temperature 40 °C
 Maximum Operating Pressure 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

In-Line  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 N/A 240 mm
(9.5 in.)
240 mm
(9.5 in.)
240 mm
(9.5 in.)
 Length N/A  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 
29 mL/min at 4475 mbar (65 psi)
** Contact Pall for multi-element integrity test values and recommended test procedures


Application
Filters - Liquid - Mycoplasma Removal (0.1 micron)