Fluorodyne® II DFL - Kleenpak™ Nova Capsules product photo Primary L

Fluorodyne® II DFL - Kleenpak™ Nova Capsules

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.

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


* Required
Description
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.

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 
12 mL/min at 2760 mbar (40 psi)
** Contact Pall for multi-element integrity test values and recommended test procedures


Application
Filters - Liquid - Sterile (0.2 micron)
Segment
Filtration