A unique three-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 Ultipleat® modular cartridge pleating design in combination with a narrow core ensures high effective filtration areas, small foot-print filter systems and 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.With the AB style cartridge format at its core, this capsule filter style can be supplied with the most comprehensive range of filter media.
Key Features and Benefits
- Encapsulated format for higher flexibility, minimized cleaning and low installation costs
- Ultipleat® filter construction allows for high flow rates and smaller filtration systems
- Small Core design for more area
- Asymmetric built-in prefilter for highest dirt-holding capacity
- > 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
- 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
- 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 |
| 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 |
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 |
Sterilization(2)
| Autoclave 'G' version | 3 x 30 minutes at 135 °C |
| Gamma irradiation ' G version' | Maximum of 50 kGy |
• 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 | NP6 | NP7 | NP8 |
| Maximum Diameter including valves | 154 mm (6.1 in.) | 154 mm (6.1 in.) | 154 mm (6.1 in.) |
| Length with hose barb inlet/outlet | 397 mm (15.6 in.) | 644 mm (25.4 in.) | 895 mm (35.2 in.) |
| Length with sanitary inlet/outlet | 335 mm (13.2 in.) | 584 mm (23.0 in.) | 834 mm (32.8 in.) |
| T Style | NT6 | NT7 | NT8 |
| Maximum Diameter including valves | 240 mm (9.5 in.) | 240 mm (9.5 in.) | 240 mm (9.5 in.) |
| Length | 349 mm (13.7 in.) | 598 mm (23.5 in.) | 848 mm (33.4 in.) |
Nominal Effective Filter Area (EFA)
|
0.95 m2 per 254 mm module (9.7 ft2 per 10 in. module) |
Typical Flow Characteristics
连接
T Style
