Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Capsules product photo Primary L

Fluorodyne® EX EDF Membrane in Mini Kleenpak™ 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..

Mini Kleenpak™ capsules are compact filters used in the laboratory for volumes of 2 L to 50 L in process development, and in pilot and manufacturing scale operations if processing requirements do not demand a large filter. These filters are the smallest capsule filters in the UpScaleSM Program range to utilize a pleated membrane, 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 scaling trials
  • Asymmetric, built-in prefilter layer for highest dirt-holding capacity
  • Validated for retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm² EFA
  • High flow rate
  • Low protein and preservative binding
  • Low extractables
  • Designed for autoclaving or SIP under wet or dry conditions

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

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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Fluorodyne® EX EDF membrane in Mini Kleenpak™ capsules, 0.2 µm removal rating, 240 cm² EFA, ¼-½ in. hose barb connections, suitable for gamma irradiation, box of 3 product photo

Fluorodyne® EX EDF membrane in Mini Kleenpak™ capsules, 0.2 µm removal rating, 240 cm² EFA, ¼-½ in. hose barb connections, suitable for gamma irradiation, box of 3

Product ID: KA02EDFP2G
Unit of Measure
1/EA
Min Order Qty
1
Removal Rating
0.2 µm
Membrane Material
Polyvinylidene fluoride (PVDF)
Maximum Batch Volume
50 L
See All Attributes
Fluorodyne® EX EDF membrane in Mini Kleenpak™ capsules, 0.2 µm removal rating, 240 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation, box of 3 product photo

Fluorodyne® EX EDF membrane in Mini Kleenpak™ capsules, 0.2 µm removal rating, 240 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation, box of 3

Product ID: KA02EDFP2S
Unit of Measure
1/EA
Min Order Qty
1
Removal Rating
0.2 µm
Membrane Material
Polyvinylidene fluoride (PVDF)
Maximum Batch Volume
50 L
See All Attributes

Documents

Datasheets

Download: English

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..

Mini Kleenpak™ capsules are compact filters used in the laboratory for volumes of 2 L to 50 L in process development, and in pilot and manufacturing scale operations if processing requirements do not demand a large filter. These filters are the smallest capsule filters in the UpScaleSM Program range to utilize a pleated membrane, 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 scaling trials
  • Asymmetric, built-in prefilter layer for highest dirt-holding capacity
  • Validated for retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm² EFA
  • High flow rate
  • Low protein and preservative binding
  • Low extractables
  • Designed for autoclaving or SIP under wet or dry conditions

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

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
Capsule Shell, Core and Endcaps  Polypropylene
Filling Bell Polycarbonate
 Sealing Technology Thermal bonding without adhesives
 

 

Operating Parameters¹

 
Maximum Operating Temperature 40 °C
 Maximum Operating Pressure  4.1 bar (60 psi) at 38 °C
 
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

 

Sterilization²

 
 Autoclave  3 x 30 minutes at 135 °C
 Gamma Irradiation  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 °C

 
 < 5 mg for the non-irradiated filter capsule
 

 

Nominal Dimensions

 
Maximum diameter including valves  53 mm (2.1 in.)
 Length - Code 2
 Length - Code 8
 105 mm (4.1 in.)
73 mm (2.9 in)
 

 

Nominal Effective Filter Area (EFA)

 
240 cm2 (0.26 ft2)
 

Removal Rating³

 
0.2 micron
 
³ Validated retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm2 effective filtration area. Please contact Pall for integrity test values.

Type

Filter Capsules

Use

Sterilizing-Grade Liquid Filtration

Ordering Information

 
Item Part Number*
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied non sterile, gamma irradiatable/autoclavable

KA02EDFP2G
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied pre-sterilized using gamma irradiation
 
KA02EDFP2S
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied non sterile, gamma irradiatable/autoclavable
 
KA02EDFP8G
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied pre-sterilized using gamma irradiation
 
KA02EDFP8S
 
* Minidisc capsules are supplied in boxes of 3

Product Summary

For smaller scale production Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Capsules maintains the high efficiency standard of other filters in larger scale range. Compact with asymmetric construction allows the capsule to minimize hold up volume and increase protein transmission. Complying with cGMP regulation the capsules are integrity tested. The products are the smallest components in Pall's UpScale Program line.

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