Documents
Datasheets
Download:Description
Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.
Kleenpak capsules with Fluorodyne EX grade EDF membrane are rugged and compact, and are designed for use in pharmaceutical manufacturing and pilot scale filter evaluation.
Further Reading
Poster: Scale Up of Direct Flow Membrane Filters
Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data
Specifications
Materials Of Construction
Filter Membrane | Prefilter Layer: Hydrophilic asymmetric PES Final Filter Layer: Hydrophilic PVDF |
Support/Drainage |
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 | 4.0 bar (58 psi) at 40 °C |
Sterilization²
Autoclave (G option only) | 5 x 60 minutes at 125 °C |
Gamma Irradiation (G option only) | Maximum of 50 kGy |
Typical Extractables in Water at 20 °C
< 10 mg per capsule |
Nominal Dimensions
Capsule Length | 157 mm (6.2 in.) |
Capsule Diameter including valves | 94 mm (3.7 in.) |
Nominal Effective Filter Area (EFA)
750 cm² (0.8 ft²) |
Type
Filter Capsules
Use
Sterilizing-Grade Liquid Filtration
Related Documents
Application Note: Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
Regulatory/Quality Documentation
Ordering Information
Item | Part Number |
Kleenpak™ Capsule with Fluorodyne® EX Grade EDF Membrane 1½ in. sanitary flange, non-sterile, gamma irradiatable/autoclavable |
KA2EDFP1G |
Kleenpak™ Capsule with Fluorodyne® EX Grade EDF Membrane 1½ in. sanitary flange, pre-sterilized using gamma irradiation |
KA2EDFP1S |
Product Summary
Fluorodyne® EX Grade EDF Membrane in Kleenpak™ Capsules are built for biopharmaceutical purpose with their durable and compact design. Using Fluorodyne EX grade EDF filters it promotes higher protein transmission and a sterile cell harvest. Its prefiltration layers and main filter system prove efficient purification in intermediate and final biological process solutions.
Reviews
We'd like your opinion! Rate and review this item