Fluorodyne® II DBL Filters

Bioburden Reduction Filters With High Flow Rates and Low Extractables Suitable for Viscous Fluids

Offered in a range of scalable formats, Fluorodyne II DBL membrane filters are effective in prefiltration and viscous fluid filtration applications including:

  • Filtration of viscous fluids
  • Liquid bioburden reduction
  • Pre-filtration
  • Applications where validated sterilizing-grade filters are not essential but reliable bioburden control is

Superior Performance

Fluorodyne II DBL filters have a 0.45 µm removal rating and incorporate a serial layer (0.65/0.45 µm) membrane construction. This unique construction ensures high flow rates and high throughputs compared with other 0.45 µm filters.

Benefits From Using Fluorodyne II DBL Filters

  • Hydrophilic PVDF membrane ensures maximum transmission of active ingredients
  • Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
  • Low extractables
  • Easy integrity testing
  • Resin- and surfactant-free

Security of Supply and Reliability of Performance

Pall manufactures the PVDF membrane used in Fluorodyne II DBL filter capsules and cartridges. All Fluorodyne II DBL filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

With a removal rating of 0.45 µm in liquids, Fluorodyne II DBL filters are validated for removal of Serratia marcescens (ATCC 14756) with a typical titer reduction (TR) of > 106, which makes these membrane filters suitable for bioburden control. This rating is supported with comprehensive validation data.



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Description

Bioburden Reduction Filters With High Flow Rates and Low Extractables Suitable for Viscous Fluids

Offered in a range of scalable formats, Fluorodyne II DBL membrane filters are effective in prefiltration and viscous fluid filtration applications including:

  • Filtration of viscous fluids
  • Liquid bioburden reduction
  • Pre-filtration
  • Applications where validated sterilizing-grade filters are not essential but reliable bioburden control is

Superior Performance

Fluorodyne II DBL filters have a 0.45 µm removal rating and incorporate a serial layer (0.65/0.45 µm) membrane construction. This unique construction ensures high flow rates and high throughputs compared with other 0.45 µm filters.

Benefits From Using Fluorodyne II DBL Filters

  • Hydrophilic PVDF membrane ensures maximum transmission of active ingredients
  • Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
  • Low extractables
  • Easy integrity testing
  • Resin- and surfactant-free

Security of Supply and Reliability of Performance

Pall manufactures the PVDF membrane used in Fluorodyne II DBL filter capsules and cartridges. All Fluorodyne II DBL filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

With a removal rating of 0.45 µm in liquids, Fluorodyne II DBL filters are validated for removal of Serratia marcescens (ATCC 14756) with a typical titer reduction (TR) of > 106, which makes these membrane filters suitable for bioburden control. This rating is supported with comprehensive validation data.

Specifications

Capsules

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Kleenpak™ Filter Capsules 400 – 3,300 30 – 1,000 Autoclave:
30 x 60 minutes at 125 °C
10 x 60 minutes at 140 °C
Gamma irradiation:
maximum of 50 kGy
Kleenpak Nova Filter Capsules 5,500 – 16,500 100 – 1,000 Autoclave:
3 x 60 minutes at 125 °C
Gamma irradiation:
maximum of 50 kGy

Cartridges

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Junior Filter Cartridges (MCY) 1,500 30 – 500 Autoclave and In Situ steam:
30 x 60 minutes at 125 °C ;
10 x 60 minutes at 140 °C
Junior Filter Cartridges (Sealkleen) 1,900 30 – 500 Autoclave and In Situ steam:
30 x 60 minutes at 125 °C
Filter Cartridges 5,500 – 16,500 100 – 1000 Autoclave and In Situ steam:
30 x 60 minutes at 125°C ;
10 x 60 minutes at 140°C

Quality Release Criteria

Kleenpak Capsules Kleenpak Nova Capsules Junior Filter Cartridges
(MCY)
Junior Filter Cartridges
(Sealkleen)
Filter Cartridges
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System
Process development
Manufacturing scale – cGMP
Integrity testing protocol during manufacture – each filter 100% tested
Test correlated to microbial retention
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Provided with a Pharmaceutical Certificate of Test

Type

Liquid Filters

Use

Bioburden Filtration