Fluorodyne® II DJL Filters

Mycoplasma Removal Filters for Applications That Demand Enhanced Sterilization Assurance

Offered in a range of scalable formats, Fluorodyne II DJL polyvinylidene fluoride (PVDF) membrane filters have been designed to sterilize fluids when a level of safety beyond a 0.2 µm-rated filter is required. Rated at 0.1 µm, these filters are recommended for the following applications:

  • Upstream processing applications with mycoplasma contamination risk (growth media, bioreactor additions)
  • Formulation and filling applications (filtration of drug product under process conditions where a 0.2 µm filter cannot be validated)

Superior Performance

A serial layer (0.2/0.1 µm) PVDF membrane construction produces high flow rates with low-fouling feeds.

Benefits From Using Fluorodyne II DJL Filters

  • Hydrophilic PVDF membrane ensures maximum transmission of active ingredients and other fluid components
  • 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 PVDF membranes used in Fluorodyne II DJL filter discs, capsules, and cartridges. All Fluorodyne II DJL filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

Fluorodyne II DJL filters are validated to have a sterilizing grade claim through bacterial challenge using Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2. Fluorodyne II DJL filters are further validated for reliable removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical titer reduction (TR) > 8 LRV.



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설명

Mycoplasma Removal Filters for Applications That Demand Enhanced Sterilization Assurance

Offered in a range of scalable formats, Fluorodyne II DJL polyvinylidene fluoride (PVDF) membrane filters have been designed to sterilize fluids when a level of safety beyond a 0.2 µm-rated filter is required. Rated at 0.1 µm, these filters are recommended for the following applications:

  • Upstream processing applications with mycoplasma contamination risk (growth media, bioreactor additions)
  • Formulation and filling applications (filtration of drug product under process conditions where a 0.2 µm filter cannot be validated)

Superior Performance

A serial layer (0.2/0.1 µm) PVDF membrane construction produces high flow rates with low-fouling feeds.

Benefits From Using Fluorodyne II DJL Filters

  • Hydrophilic PVDF membrane ensures maximum transmission of active ingredients and other fluid components
  • 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 PVDF membranes used in Fluorodyne II DJL filter discs, capsules, and cartridges. All Fluorodyne II DJL filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

Fluorodyne II DJL filters are validated to have a sterilizing grade claim through bacterial challenge using Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2. Fluorodyne II DJL filters are further validated for reliable removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical titer reduction (TR) > 8 LRV.

규격사양

Available Formats

Discs

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

Capsules

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume (L) Sterilization Conditions
Mini Kleenpak™ 20 Filter Capsules 20 0.05 – 2 Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation
Mini Kleenpak Filter Capsules 200 2 – 50 Autoclave: 3 x 60 minutes at 125 °C
Gamma irradiation: maximum of 50 kGy
Kleenpak Filter Capsules 400 – 3,300 30 – 1,000 Autoclave: 5 x 60 minutes at 140 °C
Gamma irradiation: maximum of 50 kGy
Kleenpak Nova Filter Capsules 2,700 – 5,500 100 – 1,000 Autoclavable: 3 x 60 minutes at 125 °C
Gamma irradiation: maximum of 50 kGy

Steam-in-Place Capsules

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume (L) Sterilization Conditions
Novasip Capsules 400 – 1,500 30 – 500 Autoclave or In Situ steam: 30 x 60 minutes at 125 °C ; 5 x 60 minutes at 140 °C

Filter Cartridges

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume (L) Sterilization Conditions
Junior Filter Cartridges (MCY Style) 400 – 1,500 30 – 500 Autoclave and In Situ steam: 30 x 60 minutes at 125 °C ; 5 x 60 minutes at 140 °C
Filter Cartridges 2,700 – 11,000 100 – 1,000 Autoclave and In Situ Steam: 30 x 60 minutes at 125°C ; 5 x 60 minutes at 140°C

Quality Release Criteria

47 mm Discs Mini Kleenpak 20 Capsules Mini Kleenpak Capsules Kleenpak Capsules Kleenpak Nova Capsules Novasip Capsules Junior Filter Cartridges (MCY Style) Filter Cartridges
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System
Process development
Manufacturing scale – cGMP
Quantitative bubble point of the 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

Mycoplasma Removal