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Fluorodyne® II DFL Filters

Sterilizing-Grade Filters With Low Extractables and High Protein Transmission

Offered in a range of scalable formats, Fluorodyne II DFL polyvinylidene fluoride (PVDF) membrane filters are recommended for sterilizing filtration of low-fouling pharmaceutical process fluids including:

  • Final drug product
  • Bulk drug substance
  • Bioprocess intermediates

Superior Performance With Final Drug Product

Fluorodyne II DFL filters have a 0.2 µm removal rating and incorporate a dual-layer PVDF membrane validated to produce sterile effluent. The inert dual-layer membrane pairing ensures high protein transmission, low extractables, and efficient filtration of low-fouling protein feeds, small molecule drug formulations, and intermediate fluids.

Benefits From Using Fluorodyne II DFL 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 amount of leachables in filtrate

Security of Supply and Reliability of Performance

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

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Fluorodyne II DFL filters are validated by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a level of 107 cfu/cm2, supported with comprehensive validation data.

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설명

Sterilizing-Grade Filters With Low Extractables and High Protein Transmission

Offered in a range of scalable formats, Fluorodyne II DFL polyvinylidene fluoride (PVDF) membrane filters are recommended for sterilizing filtration of low-fouling pharmaceutical process fluids including:

  • Final drug product
  • Bulk drug substance
  • Bioprocess intermediates

Superior Performance With Final Drug Product

Fluorodyne II DFL filters have a 0.2 µm removal rating and incorporate a dual-layer PVDF membrane validated to produce sterile effluent. The inert dual-layer membrane pairing ensures high protein transmission, low extractables, and efficient filtration of low-fouling protein feeds, small molecule drug formulations, and intermediate fluids.

Benefits From Using Fluorodyne II DFL 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 amount of leachables in filtrate

Security of Supply and Reliability of Performance

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

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Fluorodyne II DFL filters are validated by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a level of 107 cfu/cm2, supported with comprehensive validation data.

규격사양

Discs

Format Effective Filtration Area
(EFA) (cm2)		 Typical Batch Volume
(L)		 Sterilization Conditions
47 mm Discs 14 0.05 – 2 Autoclave

Capsules

Format Effective Filtration Area
(EFA) (cm2)		 Typical Batch Volume
(L)		 Sterilization Conditions
Mini Kleenpak 20 Capsules 20 0.05 – 2 Pre-sterilized, subject to a minimum of 25 kGy
Mini Kleenpak Capsules 200 2 – 50 Autoclave: 3 x 60 minutes at 125 °C
Gamma irradiation: maximum of 50 kGy
Kleenpak Capsules 400 – 3,300 5 – 500 Autoclave (G and blank option only): 30 x 60 minutes at 125 °C ; 10 x 60 minutes at 140 °C
Gamma irradiation: maximum of 50 kGy
Kleenpak Nova Capsules 2,700 – 16,500 100 – 1000 Autoclave (G option only): 3 x 60 minutes at 125 °C
Gamma irradiation (G option only): maximum of 50 kGy

Steam-In-Place Capsules

Format Effective Filtration Area
(EFA) (cm2)		 Typical Batch Volume
(L)		 Sterilization Conditions
Novasip™ Filter Capsules 400 – 1,500 30 – 500 Autoclave or In Situ Steam: 30 x 60 minutes at 125 °C ; 10 x 60 minutes at 140 °C

Cartridges

Format Effective Filtration Area
(EFA) (cm2)		 Typical Batch Volume
(L)		 Sterilization Conditions
Junior Filter Cartridges (MCY & SBF Style) MCY: 400 – 1,500
SBF: 400		 MCY Style: 30 – 500
SBF Style: 2 – 50		 Autoclave and In Situ Steam: 30 x 60 minutes at 125 °C ; 10 x 60 minutes at 140 °C
Junior Filter Cartridges (Sealkleen™ Style) 900 – 1,900 30 – 500 Autoclave and In Situ Steam: 30 x 60 minutes at 125 °C
Filter Cartridges 2,700 – 16,500 100 – 1000 Autoclave and In Situ Steam: 30 x 60 minutes at 125 °C ; 10 x 60 minutes at 140 °C


47 mm Discs Mini Kleenpak 20 Capsules Mini Kleenpak Capsules Kleenpak Capsules Kleenpak Nova Capsules Novasip Filter Capsules Junior Filters (Sealkleen Style) Junior Filter Cartridges (MCY & SBF Styles) Filter Cartridges
Designed, developed, manufactured in accordance with an
ISO 9000-certified Quality Management System		 ● ● ● ● ● ● ● ● ●
Process development ● ● ● ●
Manufacturing scale – cGMP ● ● ● ● ● ● ● ●
Quantitative bubble point
of membrane		 ● ● ● ● ● ● ● ● ●
Integrity testing protocol
during manufacture – lot only		 N/A ●
Integrity testing protocol
during manufacture –
each filter 100% tested		 N/A ● ● ● ● ● ● ●
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 ● ● ● ● ● ● ● ●

종류

Liquid Filters

사용

Sterilizing-Grade Liquid Filtration

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