pall,颇尔,Fluorodyne EX Grade EDF Membrane in Kleenpak Nova 囊式滤器,

pall,颇尔,Fluorodyne EX Grade EDF Membrane in Kleenpak Nova 囊式滤器

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters.Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 10⁷ cfu/ cm² of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (50 L to > 1000 L).Kleenpak Nova 囊式过滤器通常可提供使用清洁型法兰或软管倒钩配件的“在线型”(NP) 或“T”型 (NT) 入口/出口配置。

Kleenpak Nova filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (> 1 m² per 10” assembly) for outstanding throughput performance.

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 chemicals ¹
不含树脂和表面活性剂
Melt-sealed, non shedding
¹ Except ketones and amides

Quality Standards

Manufactured for use in conformance with cGMP
Individual filter elements are 100% integrity tested - test correlated to microbial retention
ISO 9000 Certified Quality System
Meets USP Biological Reactivity Test in vivo for Class VI-121 °C Plastics
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
Support/Drainage	聚丙烯
Core/End Caps	聚丙烯
Cage	Polypropylene with TiO₂ whitener¹
O 型圈	Silicone elastomer
Sealing Technology	Thermal bonding without adhesives
Housing Bowl	聚丙烯
Housing Head	Polypropylene with TiO₂ whitener¹

¹ TiO₂ is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters²


Maximum Operating Temperature	40 °C
最大操作压力	3 bar (44 psi) at 40 °C
Maximum Differential Pressure	3 bar (44 psi) at 40 °C

² In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization³


Autoclave (G option only)	1 x 60 minutes at 135 °C
Gamma Irradiation (G option only)	Maximum of 50 kGy

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

Typical Extractables in Water at 20 °C^*

< 50 mg after 4 hours extraction (per 10 in. capsule)

* Tested on elements without pre-flushing

Nominal Dimensions


同轴的	NP5	NP6	NP7	NP8
Maximum Diameter including valves	154 mm (6.1 in.)	154 mm (6.1 in.)	154 mm (6.1 in.)	154 mm (6.1 in.)
Length with hose barb inlet/outlet	275 mm (10.8 in.)	397 mm (15.6 in.)	644 mm (25.4 in.)	895 mm (35.2 in.)
Length with sanitary inlet/outlet	213 mm (8.4 in.)	335 mm (13.2 in.)	584 mm (23.0 in.)	834 mm (32.8 in.)
T-style	NP5	NT6	NT7	NT8
Maximum Diameter including valves	不可用	240 mm (9.5 in.)	240 mm (9.5 in.)	240 mm (9.5 in.)
Length	不可用	349 mm (13.7 in.)	598 mm (23.5 in.)	848 mm (33.4 in.)