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    17-18 LHPVND PDF

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    OPAZOSC

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    17-18 LHPVND PDF

    Uploaded by

    OPAZOSC
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    17-18 LHPVND.pdf

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    18 views1 page

    17-18 LHPVND PDF

    Uploaded by

    OPAZOSC

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    FluoroPV Filter Cartridges

    ® M aterials of Construction
    PVDF Membrane · Sterile Liquid Filter Filter Media
    LHPVND: Single-Layer Hydrophilic PVDF Membrane
    DLHPVNDR: Double-Layer Hydrophilic PVDF Membrane
    Support Polypropylene

    ® Cage/Core/End Caps Polypropylene


    FluoroPV Filter Cartridges are composed of a
    unique hydrophilic polyvinylidene fluoride (PVDF) mem-
    brane characterized by low extractable and protein
    Operating Conditions Flow Rate Characteristics
    binding. They are suitable for the sterilized filtration of
    Max. Operating Pressure 6.9 bar (100 psi) at 25 °C 150

    Differential Pressure (kPa)


    pharmaceutical liquids including ophthalmic liquids, 4.0 bar (58 psi) at 60 °C
    2210
    2222
    120
    biological and other diluted preservative solutions. 2.4 bar (35 psi) at 80 °C
    4522
    Max. Differential Pressure Forward 6.9 bar (100 psi) at 25 °C 90
    Forward 4.0 bar (58 psi) at 60 °C
    60
    Forward 2.4 bar (35 psi) at 80 °C
    Reverse 3.0 bar (44 psi) at 25 °C 30
    Forward 1.0 bar (15 psi) at 80 °C
    Features and Benefits
    0.58m²/ Φ 69-10 inch
    0
    Low extractable and protein binding Effective Filtration Area 0 10 20 30 40 50 60 70
    Water Flow Rate (L/min)10" @20°C,1.005cP
    Broad chemical compatibility and temperature resistance

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


    Sterilization

    Inline Steam Sterilization Up to 100 forward cycles and 50 reverse cycles


    Quality Standards (LHPVND & DLHPVNDR) (135 °C for 30 min < 0.3 bar per cycle)

    Bacterial quantitative retention of 107 CFU/cm2 Brevundimonas Autoclave up to 400 cycles (130°C for 30min per cycle)
    (LHPVND & DLHPVNDR)
    Diminuta (ATCC 19146) according to ASTM F838 methodology .
    Sterile Filtration

    100% Integrity testing in manufacturing .

    Each filter is fully traceable with unique serial number . Integrity Test Data
    Manufactured in a facility which adheres to ISO 9001:2015 Practices .
    Bubble Point BP : ≥ 0.32 MPa(water), LHPVND (0.22 µm)
    Full Regulatory Compliance with following :
    Bio-burden Reduction

    Diffusion Flow DF : ≤ 20 ml/min/10"@ 0.28 MPa, LHPVND (0.22 µm)


    · 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: Ordering Information
    Meet the requirement of USP <87> In Vitro Cytotoxicity Test ;
    Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121°C plastics
    · TOC/Conductivity at 25 °C：Autoclaved filter effluent meet the USP<643> for Total Organic
    LHPVND Removal Ratings End Cap Nominal Length Seal Material -P
    Pre-Filtration

    Carbon and USP<645> for Water Conductivity per WFI requirements after a UPW flush of [Single-Layer]
    0010 = 0.10μm HSF = 226/Fin (PBT Insert) 05 = 5" S = Silicone
    specified volume.
    · Particle Shedding: Autoclaved filter effluent meet the USP<788>for large volume Injections . 0022 = 0.22μm HSC = 226/Flat (PBT Insert) 10 = 10" E = EPDM
    · Indirect Food Additive: All component materials meet the FDA Indirect Food Additive requirements
    cited in 21 CFR 177-182.
    0045 = 0.45μm HTF = 222/Fin (PBT Insert) 20 = 20" V = Viton
    0065 = 0.65μm HTC = 222/Flat (PBT Insert) 30 = 30" P = PFA/Viton
    All-Fluorine Filters

    0100 = 1.0μm DOE = Double Open End 40 = 40"

    Typical Applications DLHPVNDR 2222 = 0.22+0.22μm


    [Double-Layer] 2245 = 0.22+0.45μm
    Antibiotics Chemicals
    Aggressive Solvents Cold and Hot WFI 6545 = 0.65+0.45μm
    Capsule Filters

    Biological Agents Ophthalmic Solutions 2210 = 0.22+0.1μm


    Blood Products Sanitizing Agents 4545 = 0.45+0.45μm
    6522 = 0.65+0.22μm
    6510 = 0.65+0.1μm
    Pharmaceutical Industry
    4510 = 0.45+0.1μm Filtration Solutions 17 - 18

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