CVGL72TP3 CTGR71TP1默克Millipore密理博Durapore滤芯CVHL72TP3

2024-07-30

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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。

Description
Catalogue NumberCVHL72TP3
Trade Name
  • Durapore®

DescriptionDurapore® Cartridge Filter with prefilter 20 in. 0.45 µm Code 7

Product Information
Device ConfigurationCartridge
Maximum 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 °C
Cartridge CodeCode 7 (2-226) O-rings w/locking-tabs
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Prefilter MaterialMixed Cellulose Esters (MCE)
Quality LevelMQ400

Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore® w/Prefilter
SterilityOther
Sterilization10 SIP cycles of 30 min or 10 autoclave cycles of 60 min @ 121 °C
WettabilityHydrophilic

Physicochemical Information
Pore Size0.45 µm
Air Diffusion at 23 °C≤30 mL/min @ 1.5 bar (22 psig) in water
Bubble Point at 23 °C≥1930 mbar (28 psig) air with water
Gravimetric 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.

Dimensions
Cartridge Nominal Length20 in. (50 cm)
Diameter6.9 cm (2.7 in.)
Filtration Area1.38 m²
Device Size20 in.

Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)

Device Material
  • Polypropylene

Seal MaterialSilicone (SI)
Support MaterialPolypropylene

Packaging Information
Material Size3
Material PackageDouble Easy-Open bag

Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

规格
OptiScale® and Millipak® Capsules
OptiScale® 25 CapsulesOptiScale® 47 CapsulesMillipak® 100Millipak® 200
Nominal Dimensions
Maximum 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 Construction
Filter membrane:Hydrophilic polyvinylidene fluoride (PVDF)
Structural components:PolypropylenePolycarbonate
Supports:PolypropylenePolycarbonate
Vent 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 °C
Maximum Differential Pressure
Forward: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 °C
Reverse:0 bar (0 psig)0.7 bar (10 psig) at 25 °C690 mbar (10 psid) at 25 °C
Bubble Point at 23 °C≥ 1790 mbar (26 psig) air with water
Gravimetric ExtractablesAfter autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:
≤ 2.5 mg≤ 5.0 mg
Bacterial EndotoxinAqueous extraction containsAqueous extraction contains
Oxidizable SubstancesMeets the requirements of the USP Oxidizable Substance Test after a water flush of:
≤ 100 mL200 mL200 mL
TOC/ConductivityThis product exhibited less than 500 ppb TOC per USP<643>and less than 1.3 µS per USP<645>after 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 USP<88>Reactivity Test for Class VI Plastics. This product is non-toxic per the current USP<88>Safety 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 Filters
Opticap® XL 2Opticap® XL 4Opticap® XL 5Opticap® XL 10Cartridge (per 10-inch element)
Nominal Dimensions
Maximum 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 Construction
Filter membrane:Hydrophilic PVDF
Prefilter media:Mixed esters of cellulose
Film edge:Polypropylene
Structural components:Polypropylene
Supports:Polypropylene
Vent O-rings:Silicone
O-rings:Silicone
Vent/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 °C
Maximum Differential Pressure
Forward: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 °C
Reverse:3.4 bar (50 psid) at 25 °C, intermittent3.5 bar (50 psid) at 25 °C, intermittent
Bubble Point at 23 °C≥ 1930 mbar (28 psig) air with water
Air 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/min
Gravimetric ExtractablesAfter autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:
With prefilter:≤ 50 mg≤ 45 mg
Without prefilter:≤ 10 mg≤ 15 mg≤ 25 mg≤ 20 mg
Bacterial 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 mL
Sterilization (with Prefilter)
Autoclaved:3 cycles of 60 minutes at 121 °C.10 cycles of 60 minutes at 121 °C
Steam Sterilization:Cannot be steam sterilized in-line.10 cycles of 30 minutes at 121 °C
Hot Water Sanitization:30 cycles of 30 minutes at 80 °C
Sterilization (without Prefilter)
Autoclaved:3 cycles of 60 minutes at 126 °C30 cycles of 60 minutes at 126 °C
Steam Sterilization:Cannot be steam sterilized in-line.30 cycles of 30 minutes at 135 °C
Hot Water Sanitization:30 cycles of 30 minutes at 80 °C
Total Organic Carbon (TOC)/ConductivityAutoclaved filter effluent meets the WFI requirement of USP<643>, for Total Organic Carbon and USP<645>for Water Conductivity at 25 ºC after a WFI flush of 11.5 L
Good 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 USP<88>Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters are non-toxic per the current USP<88>Safety 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.

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默克Millipore密理博Durapore滤芯CVHL72TP3 CVGL72TP3 CTGR71TP1

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