설명
Supor EAV bioburden PES capsule filter allows for reduced sizing of filter systems with improved process efficiencies when the 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.
Pall Kleenpak™ capsules are a rugged and compact bioburden PES capsule filter 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
- Broad pH compatibility for processing a wide range of buffers and other fluids
- Kleenpak™ capsule format eliminates housing cleaning and associated validation for ease of use and integration into 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
- ISO 9001 Certified Quality System
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
- Certificate of Test provided includes:
- Fabrication Integrity
- Materials of constructions
- Effluent quality for cleanliness, TOC , water conductivity, pH and pyrogens
규격사양
Materials of Construction
Membrane | Hydrophilic polyethersulfone |
Support and Drainage Layers | Polypropylene |
End Cap, Core and Cage | Polypropylene |
Outer Shell | Polypropylene |
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 |
Maximum Operating Pressure | 5.2 bar (75 psi) |
Maximum Differential Pressure | 4.1 bar (59 psi) |
1 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Sterilization2
Autoclave | 10 cycles x 60 minutes at 125 °C, slow exhaust |
Gamma Irradiation | Maximum dose: 50 kGy |
2 For Code G version only. Membrane has to be wet for autoclave sterilization
Please refer to service instructions or contact Pall for more details.
Extractables
Typical Extractables in water at 20 °C | < 10 mg per capsule |