Fluorodyne® EX EDF - Kleenpak™ Nova Capsules product photo Primary L

Fluorodyne® EX EDF - Kleenpak™ Nova Capsules

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (50 L to > 1000 L). Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings.

Kleenpak Nova filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (> 1 m2 per 10” assembly) for outstanding throughput performance.

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 chemicals
  • Resin and surfactant-free 
  • Melt-sealed, non shedding
    1 Except ketones and amides

Quality Standards

  • Manufactured for use in conformance with cGMP 
  • Individual filter elements are 100% integrity tested - test correlated to microbial retention
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C Plastics
  • Certificate of Test provided includes:
    • Fabrication Integrity 
    • Bacterial Retention 
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

Further Reading

 Poster: Scale Up of Direct Flow Membrane Filters

 Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data


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Description

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (50 L to > 1000 L). Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings.

Kleenpak Nova filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (> 1 m2 per 10” assembly) for outstanding throughput performance.

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 chemicals
  • Resin and surfactant-free 
  • Melt-sealed, non shedding
    1 Except ketones and amides

Quality Standards

  • Manufactured for use in conformance with cGMP 
  • Individual filter elements are 100% integrity tested - test correlated to microbial retention
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C Plastics
  • Certificate of Test provided includes:
    • Fabrication Integrity 
    • Bacterial Retention 
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

Further Reading

 Poster: Scale Up of Direct Flow Membrane Filters

 Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data
Specifications

Materials Of Construction

 
Filter Membrane Prefilter Layer: Hydrophilic asymmetric PES
Final Filter Layer: Hydrophilic 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 with TiO2 whitener¹
 
¹ TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables


Operating Parameters²

 
Maximum Operating Temperature  40 °C 
Maximum Operating Pressure 3 bar (44 psi) at 40 °C
Maximum Differential Pressure 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

 
Autoclave (G option only)  1 x 60 minutes at 135 °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*

 
< 50 mg after 4 hours extraction (per 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 NP5 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)

 
1.1 m² per 254 mm capsule (11.8 ft² per 10 in. capsule)
0.53 m² per 125 mm cartridge (5.7 ft² per 5 in. cartridge)
 


Integrity Test Values (Air test gas, water wet)**

 
Values for 10 in. capsule at 20°C  
Max. allowable Forward Flow (air test gas) Water wet 30 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