Supor EX grade ECV filters are high capacity, high flow rate 0.2um sterilizing grade filters validated for the retention of B.diminuta (ATCC 19146) at a challenge level of 107 cfu per cm2 membrane.A unique polyethersulfone (PES) membrane pairing ensures Supor EX grade ECV filters deliver highly efficient filtration of cell harvest material, process intermediates, growth media, buffers and final bulk biological process fluids.Supor EX grade ECV filters also deliver unrivalled efficiency with more viscous process streams.
颇尔's AB-style filters are replaceable cartridges sized for medium-to-large-scale manufacturing operations (100 L to > 1000 L).They feature a double 226 O-ring (颇尔 Code 7) adapter as for use with standard “Code 7” sanitary stainless steel housing assemblies.
Supor EX grade ECV filters are also available in the 颇尔 Kleenpak™ Nova filter capsule format.
A validation package for Supor EX grade ECV filters supports the assurance of safety within your process.
Key Features and Benefits
- Available in 5 inch, 10 inch, 20 inch and 30 inch configurations for coverage of a broad range of fluid volumes
- Asymmetric PES membrane for excellent flow rates and high capacity per unit membrane area
- Laid-over pleat filter construction with narrow core design maximizes available area for high device throughputs
- Low protein and preservative binding
- Fluid compatibility over a broad pH range for use in multiple applications
- 2D data matrix marking for electronic traceability using a hand-held scanner
Quality Standards
A Certificate of Test provided with every filter documents the following:- Filters are manufactured in a controlled environment
- Filter elements are manufactured for use in conformance with cGMP
- Filters’ materials of construction meet USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
-
Q.C. lot release tests
- Fabrication Integrity - each filter has successfully passed a Forward Flow integrity test correlated to bacterial retention per modified ASTM F838-05
- Lot sample bacterial retention tests with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 CFU/cm2
- Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens per USP standard methods
- EP 0 667 800
- EP 0 982 061
- EP 1 380 331
- US 5,543,047
- US 5,690,765
- US 5,725,784
- US 6,113,784
- US 7,083,564
- US 7,318,800
材料成分
| Filter Membrane | Dual Layer PES membrane |
| Support/Drainage | 聚丙烯 |
| Core/End Caps/ Fin/Adaptor | 聚丙烯 |
| Cage | Polypropylene with TiO2 whitener¹ |
| O 型圈 | Silicone elastomer |
| Sealing Technology | Thermal bonding without adhesives |
1 TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables
Operating Parameters2
| Maximum Differential Pressure (Forward Direction) |
5.0 bar (72.5 psi) at 40 °C |
2 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Sterilization
| Autoclave | 5 x 60 minute cycles at 125°C |
| In Situ Steam³ |
5 x 60 minute cycles at 125°C |
3Maximum differential pressure 300 mbar in forward direction
Typical Non Volatile Residue (NVR) Extractables in Water at 20°C*4
| < 150 mg NVR after 24 hours extraction (per 10 in. cartridge) | |
4Tested on elements without pre-flushing after one 60 minute autoclave cycle at 125°C
Nominal Effective Filter Area (EFA) and Clean Water Flow Rates
| Filter Length (inches) (mm) | EFA (ft2) (m2) | Clean Water Flow at 100 mbar DP – L/min |
| 5 (125) | 5.6 (0.52) | 8.5 |
| 10 (254) | 11.2 (1.04) | 17 |
| 20 (508) | 22.4 (2.08) | 34 |
| 30 (762) | 33.6 (3.12) | 51 |
Integrity Test Values (Air test gas, water wet)**
| Values for 10 in. cartridge at 20°C | |
| Max. allowable Forward Flow (air test gas) |
21 mL/min at 2760 mbar (40 psi) |
** Contact us for integrity test values for other filter sizes or other fluid values and recommended test procedures
| 项目 | Nominal Length | Part Number |
|
Supor® EX grade ECV Membrane Filter Cartridge 颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock* and flat top |
125 mm (5 in.) | AB05UECV2PH4 |
|
Supor® EX grade ECV Membrane Filter Cartridge 颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock* and fin |
254 mm (10 in.) | AB1UECV7PH4 |
|
Supor EX grade ECV Membrane Filter Cartridge 颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock* and fin |
508 mm (20 in.) | AB2UECV7PH4 |
|
Supor EX grade ECV Membrane Filter Cartridge 颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock* and fin |
762 mm (30 in.) | AB3UECV7PH4 |
* Please contact us for availability of product with alternative adaptor fittings and o-ring materials
