Duredunty Filter Cartridges use a double-layer PES membrane which provides great reliability in filtration and sterilization. They are designed for the filtration of a broad range of pharmaceutical products and the removal of particles, cysts, oocysts and bacteria in aqueous filtration filtration application, while providing superior low rates and high particle removal efficiency when compared to other sterilizing grade filter cartridges.
Manufactured in a facility which adheres to ISO 9001: 2015 Practices .
? Bacterial Endotoxin : Aqueous extraction of autocalved filter contains <0.25 EU/ml as determined by Limulus Amebcyte Lysate (LAL),USP<85>.
? Non-fiber Releasing : Component materials meet the criteria for a "Non-fiber-releasing filter" as defined in 21 CFR 210.3(b)(6).
? Component Material Toxicity :Meet the requirement of USP <87> In Vitro Cytotoxicity Test ; Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121℃ plastics
? TOC/Conductivity at 25 ℃：Autoclaved filter effluent meet the USP<643> for Total Organic Carbon and USP<645> for
? Water Conductivity per WFI requirements after a UPW flush of specified volume .
? Particle Shedding : Autoclaved filter effluent meet the USP<788>for large volume Injections .
? Indirect Food Additive：All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 , and EU framework regulation [1935/2004/EC].
Biological Vaccines
Blood Products
LVP and SVP
Lyophilization Freeze-dried Powder
Ophthalmic Solutions
Sterile API
Materials of Construction
| Filter Media | Double-Layer PES Membrane |
Support | Polypropylene |
| Core/Cage/End Caps | Polypropylene |
Operating Conditions
| Max. Operating Pressure | 6.9 bar (100 psi) at 25 °C 4.0 bar (58 psi) at 60 °C 2.4 bar (35 psi) at 80 °C |
Max. Differential Pressure | Forward 6.9 bar (100 psi) at 25 °C 4.0 bar (58 psi) at 60 °C 2.4 bar (35 psi) at 80 °C Reverse 3.0 bar (44 psi) at 25 °C 1.0 bar (15 psi) at 80 °C |
| Effective Filtration Area | 0.6m2 / Φ 69-10 inch |
Sterilization
Inline Steam Sterilization | up to 100 cycles (135°C for 30min< 0.3 bar per cycle) |
| Autoclave | up to 200 cycles (130°C for 30min per cycle) |
Integrity Test Data
Bubble Point | ≥ 0.34 MPa(water), 0.45+0.22μm |
| Diffusion Flow | ≤ 25 ml/min/10”@ 0.275MPa (water), 0.45+0.22μm |
Food and Biological Safety
| Extractables | < 30mg per 10 inch |
| Endotoxins | < 0.25EU/mL |
Meets the requirements for food contact: European Regulation (EC) Number 1935/2004
Integrity Test Parameters
| 2210 =0.22+0.1μm | 2222 =0.22+0.22μm | 4522 =0.45+0.22μm | 4545 =0.45+0.45μm | 6545 ＝0.65+0.45μm | |
| Diffusional Flow (10″Cartridge) | ≤25ml/min @3000mbar | ≤15ml/min @2750mbar | ≤25ml/min @2750mbar | ≤15ml/min @1600mbar | ≤25ml/min |
| Bubble Point (in water@ 23°C) | ≥ 3.8 bar | ≥ 3.4 bar | ≥ 3.4 bar | ≥ 2.0 bar | ≥ 2.0 bar |
The Integrity Test is a non-destructive test that can be performed by the user to ensure the filter is installed correctly and ready for operation.
Ordering Infomation
| Type | Removal Ratings | End Cap | Nominal Length | Seal Material | Industry |
DPSDDT | 2210=0.22+1.0μm 2222=0.22+0.22μm 4522=0.45+0.22μm 6522=0.65+0.45μm | HSF=226 /Fin (PBT Insert) HSC=226 /Flat (PBT Insert) HTF=222 /Fin (PBT Insert) HTC=222 /Flat (PBT Insert) DOE=Double Open End | 05= 5" 10=10" 20=20" 30=30" 40=40" | S=Silicone E=EPDM V=Viton P=PFA/Viton | P=Pharmaceutical |
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