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Fluorodyne™ II DFL membrane in Kleenpak™ Nova capsules

PVDF sterilizing grade filters with low extractables and high protein transmission

Fluorodyne™ II DFL membrane in Kleenpak™ Nova capsules, a Pall Life Sciences product, are 0.2 micron-rated sterilizing grade filters that are well suited for medium- to large-scale biopharmaceuticals production.

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.

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (100 L to > 1000 L), and are often selected by the end user following scaling studies using the smaller Kleenpak capsule formats. Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings. With the AB-style filter cartridge at their core, Kleenpak Nova filter capsules can be supplied with the most comprehensive range of filter media among all of Pall’s single-use capsules.

Key Features and Benefits

Encapsulated format for higher flexibility, minimized cleaning and low installation costs
Incorporated prefiltration layer
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

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
Materials of Construction
Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

mRNA Manufacture Solution

主讲嘉宾:刘静

课程分类:线上应用课程, 线上专题课程 – 细胞治疗名家课堂

  1. mRNA 市场概览和展望
  2. 质粒的制备工艺
  3. mRNA制备工艺

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