Fluorodyne® II DFL Filter Cartridges

Description

These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm2 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.

Pall’s 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), featuring 226 O-rings as standard. 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 chemicals¹
Resin and surfactant-free
Melt-sealed, non shedding
¹ 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

Specification

Materials of Construction

Filter Membrane

Hydrophilic modified PVDF

Support/Drainage

Polypropylene

Core/End Caps

Polypropylene

Cage

Polypropylene with TiO2 whitener1

O-rings

Silicone elastomer

Sealing Technology

Thermal bonding without adhesives

1 TiO 2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters 2

Maximum Temperature

80 ºC

Maximum Differential Pressure (Forward Direction)

5.3 bar (77 psi) at 50 °C
3.4 bar (49 psi) at 80 °C

Maximum Differential Pressure (Reverse Direction)

0.3 bar (4 psi)

2 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 ºC. 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 °C³

< 5 mg per 254 mm (10 in.) cartridge

3 Tested on elements without pre-flushing

Nominal Effective Filter Area (EFA)

5500 cm2 (5.9 ft2) per 254 mm (10 in.) cartridge

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

Max. allwable forward flow values
for 254 mm (10 in.) cartridge at 20°C

12 mL/min at 2760 mbar (40 psi)

Document

Download Here

Ask A Question

Would you like to receive more information about our products and services? Don't hesitate to contact us

Point of Product

Description

Specification

Document