Fluorodyne® EX Grade EDT Filters

Mycoplasma Removal Filters for Applications That Demand Enhanced Sterilization Assurance

Offered in a range of scalable formats, Fluorodyne EX grade EDT membrane filters are validated 0.1 µm-rated filters to be used where sterility assurance and economical filtration are paramount. These filters are recommended for applications with an increased risk of mycoplasma contamination, such as:

  • Growth media
  • Bioreactor additions

Superior Performance

Fluorodyne EX grade EDT filters have a 0.1 µm removal rating and feature a unique three-layer membrane with a hydrophilic asymmetric polyethersulfone (PES) prefilter layer and hydrophilic polyvinylidene fluoride (PVDF) final filter layers. This construction enables high flow rates, outstanding throughput, and superior retention of mycoplasma and bacteria.

Benefits From Using Fluorodyne EX Grade EDT Filters

  • Inert membrane combination ensures maximum transmission of fluid components
  • Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
  • Asymmetric built-in prefilter provides exceptional throughput
  • Exceptional throughput due to unique cartridge construction results in compact filter systems

Security of Supply and Reliability of Performance

Pall manufactures the PES and PVDF membranes used in Fluorodyne EX EDT filter capsules and cartridges. All Fluorodyne EX EDT filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

Fluorodyne EX grade EDT filters are validated to have a sterilizing-grade claim by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2. With > 10 log Acholeplasma laidlawii and Mycoplasma orale retention, Fluorodyne EX grade EDT filters are further validated for reliable mycoplasma removal.



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설명

Mycoplasma Removal Filters for Applications That Demand Enhanced Sterilization Assurance

Offered in a range of scalable formats, Fluorodyne EX grade EDT membrane filters are validated 0.1 µm-rated filters to be used where sterility assurance and economical filtration are paramount. These filters are recommended for applications with an increased risk of mycoplasma contamination, such as:

  • Growth media
  • Bioreactor additions

Superior Performance

Fluorodyne EX grade EDT filters have a 0.1 µm removal rating and feature a unique three-layer membrane with a hydrophilic asymmetric polyethersulfone (PES) prefilter layer and hydrophilic polyvinylidene fluoride (PVDF) final filter layers. This construction enables high flow rates, outstanding throughput, and superior retention of mycoplasma and bacteria.

Benefits From Using Fluorodyne EX Grade EDT Filters

  • Inert membrane combination ensures maximum transmission of fluid components
  • Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
  • Asymmetric built-in prefilter provides exceptional throughput
  • Exceptional throughput due to unique cartridge construction results in compact filter systems

Security of Supply and Reliability of Performance

Pall manufactures the PES and PVDF membranes used in Fluorodyne EX EDT filter capsules and cartridges. All Fluorodyne EX EDT filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

Fluorodyne EX grade EDT filters are validated to have a sterilizing-grade claim by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2. With > 10 log Acholeplasma laidlawii and Mycoplasma orale retention, Fluorodyne EX grade EDT filters are further validated for reliable mycoplasma removal.

규격사양

Capsules

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Mini Kleenpak™ Filter Capsules 200 2 – 50 Autoclavable: 3 x 30 minutes at up to 135 °C
Gamma irradiation: maximum of 50 kGy
Kleenpak Nova Filter Capsules 4,600 – 28,500 100 – 1,000 Autoclave: 3 x 30 minutes at 135 °C
Gamma irradiation: maximum of 50 kGy

Cartridges

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Filter Cartridges 4,600 – 28,500 100 – 1,000 Autoclave: 3 x 60 minutes at 135°C
In Situ Steam: 5 x 60 minutes at 135°C

Quality Release Criteria

Mini Kleenpak Filter Capsules Kleenpak Nova Filter Capsules 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 – 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