Supor EAV 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. Supor EAV filters are also effective prefilters for protection and extended life of 0.2 µm sterilizing grade and finer membrane filters where required.
颇尔 Kleenpak™ capsules are rugged and compact filter capsules available with a broad range of filter media and in 4 different sized formats designed for a variety of small to large scale pharmaceutical manufacturing applications with volumes of 30 L to 1000 L.
Features and Benefits of Supor EAV Filters
- 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 bacterial loading
- pH 兼容性广,可处理多种缓冲液和流体
- Kleenpak™ capsule format eliminates housing cleaning and associated validation, for ease of use and integration into single use disposable systems
- 低结合性聚醚砜膜可最大限度的传输蛋白质
Quality Standards
- 100% integrity tested
- Manufactured for use in conformance with cGMP
- Each filter is fully traceable by individual marked lot and serial number
- 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 includes:
- Fabrication Integrity
- Materials of constructions
- Effluent quality for cleanliness, TOC , water conductivity, pH and pyrogens
材料成分
膜 | Hydrophilic polyethersulfone |
Support and Drainage Layers | 聚丙烯 |
End Cap, Core and Cage | 聚丙烯 |
Outer Shell | 聚丙烯 |
Physical Dimensions
Diameter incl.Valves | 109 mm (4.2 in.) |
Total Length (Code 1) | 174 mm (6.8 in.) |
Total Length (Code 6) | 210 mm (8.3 in.) |
Total Length (Code 16) | 192 mm (7.5 in.) |
Effective Surface Area | 0.21 m2 (1.6 ft2) |
Operating Parameters1
Maximum Temperature | 40 °C |
最大操作压力 | 5.2 bar (75 psi) |
Maximum Differential Pressure | 4.1 bar (59 psi) |
Sterilization2
Autoclave | 10 cycles x 60 minutes at 125 °C, slow exhaust |
Gamma Irradiation | Maximum dose:50 kGy |
Please refer to service instructions or contact 上海羽令 for more details.
Extractables
Typical Extractables in water at 20 °C | < 10 mg per capsule |