Supor grade EAV membrane filters allow for reduced sizing of filter systems with improved process efficiencies when use of validated sterilizing grade filters is not essential, but reliable bioburden control is required. Supor grade EAV membrane filters are also effective prefilters for protection and extending the life of 0.2 µm sterilizing-grade and finer membrane filters where required.
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.
特色及优点
- Hydrophilic, controlled asymmetric polyethersulfone (PES) membrane ensures high microbial and particulate reduction with outstanding service life
- Bacterial titer reduction in excess of 6 log for Brevundimonas diminuta ensures low bioburden levels in filtrate, regardless of bacteria or particle loading
- pH 兼容性广，可处理多种缓冲液和流体
- High membrane area featuring 颇尔-patented cresent-shaped laid-over pleat construction combined with a narrow diameter core guarantees high flow rates, robustness and smaller multi-cartridge assemblies
- Kleenpak™ capsule formats eliminate housing cleaning and associated validation, for ease of use and integration into Allegro single-use disposable systems
- Low-binding polyethersulfone membrane for maximum transmission of proteins
Quality Standards
- 100% integrity tested
- Manufactured for use in conformance with cGMP
- Each filter is fully traceable by individual marked lot and serial number
- Manufactured under an ISO 9001 Certified Quality System
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
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Certificate of Test provided confirms:
- Fabrication Integrity
- Bacterial Retention
- Materials of construction
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Effluent quality for cleanliness, TOC, water conductivity, pH and pyrogens
材料成分
| Filter Membrane | Hydrophilic asymmetric PES |
| 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 | Polyetherimide with TiO2 whitener |
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 |
Sterilization³
| Autoclave (G option only) | 1 x 60 minutes at 135 °C |
| Gamma irradiation (G option only) | Maximum of 50 kGy |
Typical Extractables in Water at 20 °C4
| < 50 mg per 254 mm (10 in.) module |
Nominal Effective Filter Area (EFA)
| 1.06 m2 per 254 mm module (11.4 ft2 per 10 in. module) |
Integrity Test Values (air test gas, water wet)5
| Max. allowable Forward Flow | Water wet 50 mL/min at 2060 mbar (30 psi) |
Nominal Dimensions
| 同轴的 | 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.) |
Kleenpak Nova In-line Capsules (NP) Typical Liquid Flow vs.Differential Pressure
Kleenpak Nova T-Style Capsules (NT) Typical Liquid Flow vs.Differential Pressure
