설명
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 Pall 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 in these0.1 micron capsule filters. A complete validation package supports the assurance of safety within your process.
Pall’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
Further Reading
Poster: A. laidlawii Filtration Through a 0.1-micron Rated Filter at Elevated Pressures Poster: Scale Up of Direct Flow Membrane Filters Article: Effect of Prefiltration on Scalability of 0.1-µm rated Membrane Filters
Article: A New Direction In Mycoplasma Removal Article: Bacterial Penetration of 0.2 μm Sterilizing- Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data
Article: Contamination Costs - Current Trends in Process Economics for Mycoplasma-Retentive Filtration of Cell Culture Media ¹
¹ Reproduced with the kind permission of European Biopharmaceutical Review magazine
² ³ External link
규격사양
Materials of Construction
| Filter Membrane |
Prefilter Layer: Hydrophilic asymmetric PES |
| Support/Drainage | Polypropylene |
| Core/End Caps | Polypropylene |
| Cage | Polypropylene with TiO2 (white colored) |
| O-rings | Silicone elastomer |
| Sealing Technology | Thermal bonding without adhesives |
| Housing Bowl | Polypropylene |
| Housing Head* | Polypropylene |
*Formulated with TiO2 whitener which does not contribute to organic extractables
Operating Parameters(1)
| Maximum Temperature | 40 °C |
| Maximum Operating Pressure | 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
| In Line | 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
In Line
T Style
관련 문서
Regulatory/Quality Documentation
주문정보
N
| Code | Module Type |
| P | In-line |
| 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 |
