CVGL72TP3 CTGR71TP1 |
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默克Millipore密理博Durapore滤芯CVHL72TP3 CVGL72TP3 CTGR71TP1 有效去除胶体和颗粒污染物。Durapore滤芯在制造过程中进行了100%的完整性测试，以确保完整性。Durapore亲水滤芯由聚偏氟乙烯(PVDF)膜与纤维素酯(RW06)预过滤层制造，更大的通量和聚丙烯组件，广泛的化学相容性。 DescriptionCatalogue NumberCVHL72TP3Trade NameDurapore® DescriptionDurapore® Cartridge Filter with prefilter 20 in. 0.45 µm Code 7Product InformationDevice ConfigurationCartridgeMaximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °CCartridge CodeCode 7 (2-226) O-rings w/locking-tabsGood Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.Prefilter MaterialMixed Cellulose Esters (MCE)Quality LevelMQ400Biological InformationBacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) TestMediaDurapore® w/PrefilterSterilityOtherSterilization10 SIP cycles of 30 min or 10 autoclave cycles of 60 min @ 121 °CWettabilityHydrophilicPhysicochemical InformationPore Size0.45 µmAir Diffusion at 23 °C≤30 mL/min @ 1.5 bar (22 psig) in waterBubble Point at 23 °C≥1930 mbar (28 psig) air with waterGravimetric ExtractablesThe extractables level was equal to or less than 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.DimensionsCartridge Nominal Length20 in. (50 cm)Diameter6.9 cm (2.7 in.)Filtration Area1.38 m²Device Size20 in.Materials InformationChemistryPolyvinylidene Fluoride (PVDF) Device MaterialPolypropylene Seal MaterialSilicone (SI)Support MaterialPolypropylenePackaging InformationMaterial Size3Material PackageDouble Easy-Open bagSpecificationsOxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L规格OptiScale® and Millipak® CapsulesOptiScale® 25 CapsulesOptiScale® 47 CapsulesMillipak® 100Millipak® 200Nominal DimensionsMaximum length:39 mm (1.52 in.) with female Luer-Lok inlet/male Luer-Lok outlet82 mm (3.24 in.) with flange inlet/hose barb outlet74 mm (2.91 in.) with flange inlet/flange outlet94 mm (3.70 in.) with hose barb inlet/hose barb outlet13 cm (5.1 in.)15.5 cm (6.1 in.)Diameter:31 mm (1.21 in)69 mm (2.75 in.)7.6 cm (3.0 in.)Weight:0.19 oz (5.5 g)2.3 oz (67 g)——Filtration Area3.5 cm²17.7 cm²500 cm² (0.54 ft²)1000 cm² (1.08 ft²)Materials of ConstructionFilter membrane:Hydrophilic polyvinylidene fluoride (PVDF)Structural components:PolypropylenePolycarbonateSupports:PolypropylenePolycarbonateVent caps:PolypropylenePolyvinylidene fluoride (PVDF)Internal seal rings:Fluoroelastomers—Housing VentCapped Vent with female Luer connections on inlet side of device.Adjustable vent with male luer and female Luer-Lok connections on inlet side of device.Maximum Inlet Pressure4.1 bar (60 psig) at 25 °C5.5 bar (80 psig) at 25 °C5.2 bar (75 psig) at 25 °CMaximum Differential PressureForward:4.1 bar (60 psig) at 25 °C5.5 bar (80 psig) at 25 °C4.1 bar (60 psid) at 25 °C1.7 bar (25 psid) at 80 °C345 mbar (5 psid) at 123 °CReverse:0 bar (0 psig)0.7 bar (10 psig) at 25 °C690 mbar (10 psid) at 25 °CBubble Point at 23 °C——≥ 1790 mbar (26 psig) air with waterGravimetric Extractables——After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:≤ 2.5 mg≤ 5.0 mgBacterial EndotoxinAqueous extraction contains—Aqueous extraction containsOxidizable Substances—Meets the requirements of the USP Oxidizable Substance Test after a water flush of:≤ 100 mL200 mL200 mLTOC/ConductivityThis product exhibited less than 500 ppb TOC per USPand less than 1.3 µS per USPafter autoclave and a WFI water flush of 15 mL.—SterilizationMay be autoclaved for 1 cycle of 60 minutes at 123 °CMay be autoclaved for 3 cycles of 60 minutes at 126 °CMay be autoclaved for 3 cycles of 90 minutes at 123 °C. Capable of 45 kilogray (4.5 Megarad) gamma exposure (cannot be steam sterilized in-line).Good Manufacturing PracticesThese products are manufactured in a Millipore facility which adheres to FDA Device Good Manufacturing Practices.Non-Fiber ReleasingDurapore membrane meets the criteria for a “non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).Component Material ToxicityComponent materials meet the requirements of USPReactivity Test for Class VI Plastics. This product is non-toxic per the current USPSafety Test.Indirect Food AdditiveThe Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.Opticap® XL Capsules and Cartridge FiltersOpticap® XL 2Opticap® XL 4Opticap® XL 5Opticap® XL 10Cartridge (per 10-inch element)Nominal DimensionsMaximum length:14.2 cm (5.6 in.)19.6 cm (7.7 in.)21.6 cm (8.5 in.)33.5 cm (13.2 in.)—Diameter:8.4 cm (3.3 in.)10.7 cm (4.2 in.)6.9 cm (2.7 in.)Filtration Area0.09 m² (0.93 ft²)0.19 m² (2.09 ft²)0.35 m² (3.7 ft²)0.69 m² (7.4 ft²)Materials of ConstructionFilter membrane:Hydrophilic PVDFPrefilter media:Mixed esters of celluloseFilm edge:—PolypropyleneStructural components:PolypropyleneSupports:PolypropyleneVent O-rings:Silicone—O-rings:—SiliconeVent/Drain¼ in. hose barb with double O-ring seal—Maximum Inlet Pressure5.5 bar (80 psi) at 23 °C2.8 bar (40 psi) at 60 °C1.0 bar (15 psi) at 80 °CMaximum Differential PressureForward:5.5 bar (80 psid) at 25 °C (with prefilter)1.0 bar (15 psid) at 80 °C (with prefilter)3.4 bar (50 psid) at 25 °C (without prefilter)5.5 bar (80 psid) at 25 °C1.8 bar (25 psid) at 80 °C345 mbar (5 psid) at 135 °CReverse:3.4 bar (50 psid) at 25 °C, intermittent3.5 bar (50 psid) at 25 °C, intermittentBubble Point at 23 °C≥ 1930 mbar (28 psig) air with waterAir DiffusionThrough a water wet membrane at ambient temperature at 1.5 bar (22 psi):Through a water wet membrane at 23 °C at 1.5 bar (22 psi):—≤ 4.5 cc/min≤ 7.5 cc/min≤ 15 cc/minGravimetric ExtractablesAfter autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:With prefilter:———≤ 50 mg≤ 45 mgWithout prefilter:≤ 10 mg≤ 15 mg≤ 25 mg≤ 20 mgBacterial EndotoxinAqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.Oxidizable SubstancesMeets the requirements of the USP Oxidizable Substance Test after a water flush of:500 mL1000 mLSterilization (with Prefilter)Autoclaved:3 cycles of 60 minutes at 121 °C.10 cycles of 60 minutes at 121 °CSteam Sterilization:Cannot be steam sterilized in-line.10 cycles of 30 minutes at 121 °CHot Water Sanitization:—30 cycles of 30 minutes at 80 °CSterilization (without Prefilter)Autoclaved:3 cycles of 60 minutes at 126 °C30 cycles of 60 minutes at 126 °CSteam Sterilization:Cannot be steam sterilized in-line.30 cycles of 30 minutes at 135 °CHot Water Sanitization:—30 cycles of 30 minutes at 80 °CTotal Organic Carbon (TOC)/ConductivityAutoclaved filter effluent meets the WFI requirement of USP, for Total Organic Carbon and USPfor Water Conductivity at 25 ºC after a WFI flush of 11.5 LGood Manufacturing PracticesThese products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices.Non-Fiber ReleasingDurapore membrane meets the criteria for a “non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).Component Material ToxicityComponent materials were tested and meet the criteria of the USPReactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters are non-toxic per the current USPSafety Test.Indirect Food AdditiveDurapore membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.European Pressure Equipment DirectiveMillipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Equipment Directive, this product does not bear the CE mark.—CVHL01TP3 CVHL02TP3 CVHL03TP3 CVHL01PP3 CVHL02PP3 CVHL03PP3 CVHL51TP3 CVHL52TP3 CVHL53TP3 CVHL51PP3 CVHL52PP3 CVHL53PP3 CVHL71TP3 CVHL72TP3 CVHL73TP3 CVHL71PP3 CVHL72PP3 CVHL73PP3 CVHL75PP1 CTGR01TP1 CTGR02TP1 CTGR03TP1 CTGR71TP1 CTGR72TP1 CTGR73TP1 CTGR75S01 KTGRA02FF3 KTGRA02HH3 KTGRA02TT3 KTGRA04FF3 KTGRA04HH3 KTGRA04TT3 KTGRA05HH1 KTGRA05TT1 KTGRA10FF1 KTGRA10HH1 KTGRA10TT1 CVGL01TP3 CVGL02TP3 CVGL03TP3 CVGL51TP3 CVGL52TP3 CVGL53TP3 CVGL71TP3 CVGL73TP3 CVGL75S01 CVVL01TP3 CVVL02TP3 CVVL03TP3 CVVL51TP3 CVVL52TP3 CVVL53TP3 CVVL71TP3 CVVL72TP3 CVVL72TP3 CVVL75S01 CVDI01TPE CVDI02TPE CVDI03TPE CVDI71TPE CVDI72TPE CVDI73TPE CVDI01TPS CVDI02TPS CVDI03TPS CVDI71TPS CVDI72TPS CVDI73TPS 默克Millipore密理博Durapore滤芯CVHL72TP3 CVGL72TP3 CTGR71TP1 |
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