pall,颇尔,配Fluorodyne II DFL 膜的 Kleenpak Nova 囊式过滤器,

pall,颇尔,配Fluorodyne II DFL 膜的 Kleenpak Nova 囊式过滤器

These validated 0.2 micron-rated sterilizing grade 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 囊式过滤器专为中等至大规模（100 升至 1000 升以上）生产环境应用而设计，通常使用较小 Kleenpak 囊式过滤器型号进行规模研究之后的终端用户会选择使用这类过滤器。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。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 颇尔’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
不含树脂和表面活性剂
Melt-sealed, non shedding
¹Except 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
- 材料成分
- Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

材料成分


Filter Membrane	Hydrophilic modified 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	聚丙烯

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

Operating Parameters²


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


Autoclavable (G option only)	3 x 60 minutes at 125 °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*


G option	< 10 mg per 254 mm (10 in.) capsule
S option	< 20 mg per 254 mm (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		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.)