pall,颇尔,配 Fluorodyne EX EDF 膜的小型Kleenpak针头过滤器,KM2EDFS

pall,颇尔,配 Fluorodyne EX EDF 膜的小型Kleenpak针头过滤器

Fluorodyne EX grade EDF filters are high capacity, low protein binding sterilizing grade filters.Incorporating a built-in prefiltration layer and validated to retain Brevundimonas diminuta (ATCC 19146) at a concentration of 10⁷CFU/ cm², Fluorodyne EX EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

小型 Kleenpak 针头过滤器囊式过滤器旨在用于实验室。Featuring the lowest surface area in 颇尔’s UpScale range and a very small hold-up volume, they are ideal for filtering the smallest quantities of fluids (up to 100 mL) with minimal losses.

Key Features and Benefits

Ideal for screening trials
Built-in, MachV asymmetric prefilter layer for long-life and low filtration costs
Low protein and preservative binding
Low extractables
Supplied pre-sterilized using gamma irradiation

Quality Standards

Meet USP Biological reactivity tests in-vivo in accordance with USP Class VI 121 °C for Biological safety
Endotoxin Level < 0.25 EU/mL using Limulus Amoebocyte Lysate (LAL) test
Cleanliness per USP Particulates in injectables
Non fiber releasing per CFR 211.72 and CFR 210.3(b)(6)

延伸阅读

海报：Scale Up of Direct Flow Membrane Filters

文章：Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier:A Comparison of Data

材料成分


Filter Membrane	Prefilter Layer:Hydrophilic asymmetric PES Final Filter Layer: Hydrophilic PVDF
Housing, Vent Plug and Support Material	聚丙烯
Sealing Technology	Insert molding

Operating Parameters¹


Maximum Operating Temperature and Pressure	5.4 bar (80 psi) at 20 °C 2.1 bar (30 psi) at 60 °C

¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization²

Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation

² Pre-sterilized Mini Kleenpak syringe filters must not be re-sterilized.Mini Kleenpak syringe filters must not be sterilized in-situ by passing steam under pressure