These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption.They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.
颇尔’s standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L), featuring 226 O-rings as standard.These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.
特点
- Low extractables
- High protein transmission
- Rapid preservative recoveries
- Easy integrity testing
- Compatible with organic solvents, acids and chemicals¹
- 不含树脂和表面活性剂
-
Melt-sealed, non shedding
¹ Except ketones and amides
Quality Standards
- 100% integrity tested
- Manufactured for use in conformance with cGMP
- 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
- 材料成分
- Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
材料成分
Filter Membrane | Hydrophilic modified PVDF |
Support/Drainage | 聚丙烯 |
Core/End Caps | 聚丙烯 |
Cage | Polypropylene with TiO2 whitener¹ |
O 型圈 | Silicone elastomer |
Sealing Technology | Thermal bonding without adhesives |
Operating Parameters²
Maximum Temperature | 80 ºC |
Maximum Differential Pressure (Forward Direction) |
5.3 bar (77 psi) at 50 °C 3.4 bar (49 psi) at 80 °C |
Maximum Differential Pressure (Reverse Direction) | 0.3 bar (4 psi) |
Sterilization
Autoclave and In Situ Steam |
30 x 60 minutes at 125°C 10 x 60 minutes at 140°C |
Typical Extractables in Water at 20 °C³
< 5 mg per 254 mm (10 in.) cartridge |
Nominal Effective Filter Area (EFA)
5500 cm² (5.9 ft²) per 254 mm (10 in.) cartridge |
Integrity Test Values (Air test gas, water wet)*
Max. allowable forward flow values for 254 mm (10 in.) cartridge at 20°C |
12 mL/min at 2760 mbar (40 psi) |
项目 | Part Number |
Fluorodyne® II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 125 mm (5 in.);颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock and fin |
AB05DFL7PH4 |
Fluorodyne® II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 125 mm (5 in.);颇尔 Code 2 double O-ring (silicone elastomer), bayonet lock, no fin |
AB05DFL2PH4 |
Fluorodyne® II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 254 mm (10 in.);颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock and fin |
AB1DFL7PH4 |
Fluorodyne® II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 508 mm (20 in.);颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock and fin |
AB2DFL7PH4 |
Fluorodyne® II DFL Membrane Filter Cartridge 0.2 micron sterilizing grade, nominal length 762 mm (30 in.);颇尔 Code 7 double O-ring (silicone elastomer), bayonet lock and fin |
AB3DFL7PH4 |