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 |
| 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
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.
