Fluorodyne™ II DJL membrane in Kleenpak™ capsules

VDF enhanced sterile liquid filtration with mycoplasma removal for low extractables and high protein transmission

SKU： N/A 分类：直流过滤, 直流过滤, 直流过滤, 生物工艺过滤, 过滤, 支原体过滤, 支原体过滤, 支原体过滤, 过滤, mRNA&脂质纳米递送系统, 病毒载体

入口/出口连接

1-1½ in (25-38 mm) sanitary flange
1 ½ in. (25-38 mm) sanitary flange
¼-½ in (6-13 mm) hose barb
½ in (13 mm) single hose barb

有效过滤面积

400 cm²
800 cm²
1500 cm²
3300 cm²

清除

Fluorodyne™ II DJL membrane in Kleenpak™ capsules, a Pall Life Sciences product, are 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction that deliver high flow rates and mycoplasma removal.

Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 23206) with a typical T_R >10¹¹ and retention of B. diminuta (ATCC 19146) at 10⁷ CFU/cm² EFA. This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

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