DESCRIPTION
Fluorodyne™ II DFL membrane filter cartridges, a Pall Life Sciences product, are 0.2 micron-rated sterilizing grade filters.
These 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.
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
+852-3069 6950
sales@gugent.com.hk
