Rev.

Date: 28-Jun-2011

Fluorodyne II DFL Membrane Filter Cartridges Description These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm effective filter area (EFA) and ensure very low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions. Palls standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L). With Code 7 fittings as standard, these cartridges are the most versatile filtration units in Palls product range, and are available with a broader range of filtration media than any other filter type. These cartridges are also available encapsulated in the Kleenpak Nova capsule format.

Features

Low extractables High protein transmission Rapid preservative recoveries Easy integrity testing Compatible with organic solvents, acids and chemicals Resin and surfactant-free Melt-sealed, non shedding
Except ketones and amides

Quality Standards

100% integrity tested Manufactured for use in conformance with cGMP ISO 9000 Certified Quality System Meets USP Biological Reactivity Test in vivo for Class VI-121 C plastics Every filter tested during manufacture Test correlated to microbial retention Certificate of Test provided includes Fabrication integrity Bacterial retention Materials of Construction Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

Specifications

Materials of Construction

Filter Membrane Support/Drainage Core/End Caps Cage O-rings Sealing Technology

Hydrophilic modified PVDF Polypropylene Polypropylene Polypropylene with TiO2 whitener Silicone elastomer Thermal bonding without adhesives

TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters
Maximum Temperature Maximum Differential Pressure (Forward Direction) Maximum Differential Pressure (Reverse Direction) 80 C 5.3 bar (77 psi) at 50 C 3.4 bar (49 psi) at 80 C 0.3 bar (4 psi)

In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction. DFL filter media may be used at 90 C. Contact Pall for further details

Sterilization
Autoclave and In Situ Steam 30 x 60 minutes at 125 C 10 x 60 minutes at 140 C

Typical Extractables in Water at 20 C

< 5 mg per 254 mm (10 in.) cartridge
Tested on elements without pre-flushing

Nominal Effective Filter Area (EFA)

5500 cm (5.9 ft) per 254 mm (10 in.) cartridge

Integrity Test Values (Air test gas, water wet)*

Max. allowable forward flow values for 254 mm (10 in.) cartridge at 20 C 12 mL/min at 2760 mbar (40 psi)

* Contact Pall for multi-element integrity test values and recommended test procedures

Ordering Information Item Fluorodyne II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 125 mm (5 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin Fluorodyne II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 125 mm (5 in.); Pall Code 2 double O-ring (silicone elastomer), bayonet lock, no fin Fluorodyne II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 254 mm (10 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin Fluorodyne II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 508 mm (20 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin Fluorodyne II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 762 mm (30 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin Part Number AB05DFL7PH4

AB05DFL2PH4

AB1DFL7PH4

AB2DFL7PH4

AB3DFL7PH4

Contact Information Copyright Pall Corporation Visit us on the Web at www.pall.com

This information is accurate as of the revision date indicated.