pall,颇尔,配Fluorodyne EX EDT 膜的 Kleenpak Nova 囊式过滤器,

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配Fluorodyne EX EDT 膜的 Kleenpak Nova 囊式过滤器
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产品介绍

pall,颇尔,配Fluorodyne EX EDT 膜的 Kleenpak Nova 囊式过滤器,
pall,颇尔,配Fluorodyne EX EDT 膜的 Kleenpak Nova 囊式过滤器

配Fluorodyne EX EDT 膜的 Kleenpak Nova 囊式过滤器

颇尔's Fluorodyne EX grade EDT filter is a 0.1 micron rated, validated, highly retentive mycoplasma control filter to be used where the sterility assurance and economical filtration of growth media or other hard-to-filter fluids is paramount.

A unique triple membrane layer construction contributes to outstanding throughput, high flow rates and the superior retention of bacteria and mycoplasma during the filtration of process fluids.

The 颇尔 patented laid-over pleat modular cartridge pleating construction in combination with a narrow core design ensures high effective filtration area per filter assembly, resulting in small foot-print filter systems with improved process efficiencies.A complete validation package supports the assurance of safety within your process.

颇尔's range of Kleenpak™ Nova capsules are designed for use in medium to large scale production environments (100 L > 1000 L), often selected by the end user following scaling studies using smaller Kleenpak capsule formats.

Key Features and Benefits

  • 100% retentive for B. diminuta as per ASTM838-05
  • Laid-over pleat filter construction allows for high flow rates and smaller filtration systems
  • Narrow core design for more area
  • Asymmetric built-in prefilter for highest dirt-holding capacity
  • Typically > 10 log A.laidlawii and M. orale retention
  • High flow rate
  • Low protein and preservative binding
  • Low extractables
  • Designed for autoclaving or SIP under wet or dry conditions

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 
    • Materials of constructions
    • Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

延伸阅读

  海报:A. laidlawii Filtration Through a 0.1-micron Rated Filter at Elevated Pressures

  Poster: Scale Up of Direct Flow Membrane Filters

  文章:Effect of Prefiltration on Scalability of 0.1-µm rated Membrane Filters
 
  文章:A New Direction In Mycoplasma Removal

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

  文章:Contamination Costs - Current Trends in Process Economics for Mycoplasma-Retentive Filtration of Cell Culture Media ¹

文章:Evaluating Performance of 0.1 µm Filters for Mammalian Cell Culture Media Filtration ²

文章:Evaluating the Scalability of 0.1 µm-rated Membrane Filters - Part 1 ³

¹ Reproduced with the kind permission of European Biopharmaceutical Review magazine
² ³ External link

 
 

材料成分

 

 
 Filter Membrane

 Prefilter Layer:      Hydrophilic asymmetric PES
 Final Filter Layers: Hydrophilic PVDF

 Support/Drainage  聚丙烯
 Core/End Caps  聚丙烯
 Cage  Polypropylene with TiO2 (white colored)
 O 型圈  Silicone elastomer
 Sealing Technology  Thermal bonding without adhesives
 Housing Bowl  聚丙烯
 Housing Head*  聚丙烯
 

*Formulated with TiO2 whitener which does not contribute to organic extractables

Operating Parameters(1)

 

 
 Maximum 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
 

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

Sterilization(2)

 
 Autoclave 'G' version  3 x 30 minutes at 135 °C
 Gamma irradiation ' G version'  Maximum of 50 kGy
 

(2) • 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 254 mm module)  
 

*Tested on elements without pre-flushing

Nominal Dimensions


 
连接 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.)
 

 

Nominal Effective Filter Area (EFA)

 
9500 cm2 (10.2 ft2) per 254 mm (10 in.) module
4600 cm2 (4.9 ft2 ) per 125 mm (5 in.) module
 

Typical Flow Characteristics

连接

T Style

Part Number:例如:NP5LUEDTP1G

N

 
Code Module Type
P 同轴的
T T-style
 


UEDT P

 
Code Filter Size
5L1 125 mm (5 in.)
6 254 mm (10 in.)
7 508 mm (20 in.)
8 762 mm (30 in.)
 


 
Code Inlet/Outlet Connections
1 1 - 11/2 in. sanitary flange inlet and outlet
9 1 in. (25 mm) single barb hose barb inlet and outlet
19 1 - 11/2 in. sanitary flange inlet and 1 in. (25 mm) single barb hose barb outlet
62 1/2 in. (13 mm) single barb hose barb inlet and outlet
162 1 - 11/2 in. sanitary flange inlet and 1/2 in. (13 mm) single barb hose barb outlet
1H3 1 - 11/2 in. sanitary flange inlet and outlet, with 1/2 in. sanitary port on outlet
1H93 1 - 11/2 in. sanitary flange inlet and 1 in. (25 mm) single barb hose barb outlet with 1/2 in. sanitary port on inlet
 


 
Code Shipping Format
G Non-sterile gamma
irradiatable/autoclavable
S Pre-sterilized using
gamma irradiation
 


 
Code Vent/Drain
Blank Staubli* vent and
stepped hose barb drain
A Staubli vent and drain
 


1Currently available only with in-line capsule format
2For In-line (code P) only
3For T-style (code T) only
*Staubli is a trademark of Staubli AG.

 


pall,颇尔,配Fluorodyne EX EDT 膜的 Kleenpak Nova 囊式过滤器
上一条pall,颇尔,配Fluorodyne II DBL 膜的 Kleenpak Nova 囊式过滤器,
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