Pharmaceutical
Home Industries Pharmaceutical FluoroPV Filter Cartridges
FluoroPV Filter Cartridges
Hydrophilic PVDF Membrane · Sterilizing Grade

Cobetter FluoroPV Filter Cartridges are made of hydrophilic polyvinylidene fluride (PVDF) membrane characterized by low extractable and protein binding. They are suitable for the sterilized filtration of pharmaceutical liquids such as ophthalmic liquids, biological and other diluted preservative solutions.


Features and Benefits

  • Low extractable and protein binding

  • Broad chemical compatibility and temperature resistance

  • Great durability proven by testing forward/reverse pulse up to 100x



Quality Standards:

  • Bacterial quantitative retention of 107 CFU/cm2 Brevundimonas Diminuta (ATCC 19146) according to ASTM F838 methodology .
  • 100% Integrity testing in manufacturing .
  • Each filter is fully traceable with serial number .

  • Manufactured in a facility which adheres to ISO 9001: 2015 Practices .

  • Full Regulatory Compliance with following :
    • 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].


Typical Applications

  • Antibiotics

  • Aggressive Solvents

  • Biologicals Agents

  • Blood Products

  • Cold and Hot WFI

  • Chemicals

  • Ophthalmic Solutions

  • Sanitizing Agents

  • Specification
  • Performance
  • Ordering Information

Materials of Construction


Filter Media

LHPVND Single-Layer Hydrophilic PVDF Membrane

DLHPVNDR Double-Layer Hydrophilic PVDF 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 Area0.58m² / Φ 69-10 inch




Sterilization


Inline Steam Sterilization

up to 100 forward cycles and 50 reverse cycles

( 135 °C for 30 min < 0.3 bar per cycle )

Autoclaveup to 400 cycles (130°C for 30min per cycle)

 



Integrity Test Data


Bubble Point

BP: ≥ 0.32 MPa(water), LHPVND(0.22 μm)

Diffusion FlowDF: ≤ 20 ml/min/10”@ 0.28 MPa, LHPVND(0.22 μm)

 





 



Flow Rate Characteristics



Ordering Infomation


TypeRemoval RatingsEnd CapNominal LengthSeal MaterialIndustry

LHPVND 








DLHPVNDR

0010=0.1μm

0022=0.22μm

0045=0.45μm

0065=0.65μm

0100=1.0μm




2222=0.22+0.22μm

2245=0.22+0.45μm

6545=0.64+0.45μm

2210=0.22+0.1μm

4545=0.45+0.45μm

6522=0.65+0.22μm

6510=0.65+0.1μm

4510=0.45+0.1μm


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






Contact Form
Corporate name* Department*
Name*
E-mail address*
Tel
Address
Leaving a message