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

Fluorodyne® II DBL Membrane in Kleenpak™ Capsules

These 0.45 micron-rated filters are predominantly used in pre-filtration applications or viscous fluid filtrations. Validated removal of Serratia marcescens (ATCC 14756)
with a typical titer reduction (TR) of > 106 ensures that they are also suitable for bioburden control. A serial layer (0.65/0.45 micron) membrane construction allows for high throughputs and high flow rates compared with other 0.45 micron-rated filters.

Kleenpak capsules are rugged and compact, can be supplied with a broad range of filter media, and can be offered in up to four different filter area sizes designed for a variety of applications in pharmaceutical manufacturing environments (volumes of 30 L to 1000 L) from small to large-scale. These in-line single-use assemblies are available with sanitary or hose barb inlet/outlet fittings.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Built in prefiltration
  • Minimal hold up volume
  • 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 0.45 micron-rated filters are predominantly used in pre-filtration applications or viscous fluid filtrations. Validated removal of Serratia marcescens (ATCC 14756)
with a typical titer reduction (TR) of > 106 ensures that they are also suitable for bioburden control. A serial layer (0.65/0.45 micron) membrane construction allows for high throughputs and high flow rates compared with other 0.45 micron-rated filters.

Kleenpak capsules are rugged and compact, can be supplied with a broad range of filter media, and can be offered in up to four different filter area sizes designed for a variety of applications in pharmaceutical manufacturing environments (volumes of 30 L to 1000 L) from small to large-scale. These in-line single-use assemblies are available with sanitary or hose barb inlet/outlet fittings.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Built in prefiltration
  • Minimal hold up volume
  • 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
End Cap, Core and Cage
Capsule Shell

Polypropylene
Polypropylene
Polypropylene
Sealing Technology Thermal bonding without adhesives

Operating Parameters¹
Maximum Operating Temperature  40 °C 
Maximum Operating Pressure 5.2 bar (75 psi) at 20 °C
4.0 bar (58 psi) at 40 °C
Maximum Differential Pressure (Forward Direction) 4.0 bar (58 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 and blank option only)  30 x 60 minutes at 125 °C
10 x 60 minutes at 140 °C
Gamma Irradiation (G option only) Maximum of 50 kGy

² Pre-sterilized Kleenpak capsules must not be re-sterilized. Kleenpak capsules must not be sterilized in-situ by passing steam under pressure

Typical Extractables in Water at 20 °C³
< 5 mg per capsule

³ Tested on capsules without pre-flushing

Nominal Dimensions

KA1 KA2 KA3 KA4
Diameter incl. Valves 94 mm (3.7 in.) 94 mm (3.7 in.) 105 mm (4.1 in.) 105 mm (4.1 in.)
Length - Code 1 117 mm (4.6 in.) 157 mm (6.2 in.) 174 mm (6.8 in.) 287 mm (11.3 in.)
Length - Code 2 158 mm (6.2 in.) 198 mm (7.8 in.) - -
Length - Code 6 157 mm (6.2 in.) 197 mm (7.7 in.) 210 mm (8.3 in.) 327 mm (12.8 in.)
Length - Code 12 137 mm (5.4 in.) 177 mm (7.0 in.) -   -
Length - Code 16 137 mm (5.4 in.) 177 mm (7.0 in.) 192 mm (7.6 in.) 305 mm (12.0 in.)

Nominal Effective Filter Area (EFA)
KA1 400 cm² (0.4 ft²)
KA2  800 cm² (0.9 ft²)
KA3 1500 cm² (1.6 ft²)
KA4 3300 cm² (3.6 ft²)









Application
Filters - Liquid - Bioburden Reduction (0.45 micron)