pall,颇尔,配Fluorodyne EX EDF 膜的小型 Kleenpak 20 囊式过滤器,KM5EDFP2S

pall,颇尔,配Fluorodyne EX EDF 膜的小型 Kleenpak 20 囊式过滤器

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 10⁷ CFU/cm², Fluorodyne EX EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.

Key Features and Benefits

• Ideal for screening trials
• Asymmetric built-in prefilter for higher dirt-holding capacity
• Low protein and preservative binding
• Low extractables

Quality Standards

• 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 lot tested during manufacture
• Test correlated to microbial retention
• Certificate of Test provided includes:
  • Fabrication Integrity
  • Bacterial Retention
  • 材料成分
  • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

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	Polypropylene (Filling Bell is polycarbonate)
Sealing Technology	Thermal bonding without adhesives

Operating Parameters ¹ ²

Maximum Operating Temperature and Pressure	1.4 bar (20 psi) at 20 °C

¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
² For continuous operation.May be exceeded during Bubble Point integrity testing.Please contact 上海羽令 for further details

Sterilization³

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

³ Pre-sterilized Mini Kleenpak 20 capsules must not be re-sterilized.Mini Kleenpak 20 capsules must not be sterilized in-situ by passing steam under pressure

Typical Hold up Volume

< 2.5 毫升

Nominal Dimensions

Capsule Length	83 mm (3.3 in.)
Capsule Diameter	67 mm (2.7 in.)

Nominal Effective Filter Area (EFA)

20 cm² (3.1 in.²)

连接

¼ – ½ in. (6 – 13 mm) stepped hose barb.Inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet

项目	Part Number
配Fluorodyne EX EDF 膜的小型 Kleenpak 20 囊式过滤器	KM5EDFP2S*

* supplied as 1 box of 3 filters

pall,颇尔,配Fluorodyne EX EDF 膜的小型 Kleenpak 20 囊式过滤器