Cytiva, KA02DFLP8G, Fluorodyne™ II DFL membrane in Kleenpak™ capsules

Fluorodyne II DFL membrane in Kleenpak capsule, 0.2 µm sterilizing grade, 200 cm² EFA, ½ - ¾ in. sanitary flange connections, suitable for gamma irradiation
Fluorodyne™ II DFL membrane in Kleenpak™ capsules, a Pall Life Sciences product, are 0.2 micron-rated sterilizing grade filters that feature low extractable levels and high protein transmissions.
These filters retain Brevundimonas diminuta (ATCC 19146) at 10 7 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.
Kleenpak capsules are rugged and compact, can be supplied with a broad range of filter media, and can be offered in up to four different filter area sizes designed for a variety of applications in pharmaceutical manufacturing environments (volumes of 30 L to 1000 L) from small to large-scale. These in-line single-use assemblies are available with sanitary or hose barb inlet/outlet fittings. Key features and benefits Encapsulated format for higher flexibility, minimized cleaning and low installation costs Built in prefiltration Minimal hold up volume Low extractables High protein transmission Rapid preservative recoveries Easy integrity testing Compatible with organic solvents, acids and chemicals ¹ Resin and surfactant-free Melt-sealed, non shedding ¹ Except ketones and amides Quality standards Manufactured for use in conformance with cGMP 100 % integrity tested 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 Material of Construction Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens