默克Millipore密理博Durapore滤芯CVHL72TP3

作者：张馨予

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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。

【详细说明】

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 Number CVHL72TP3
Trade Name

Durapore®

Description Durapore® Cartridge Filter with prefilter 20 in. 0.45 µm Code 7
Product Information
Device Configuration Cartridge
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 Code Code 7 (2-226) O-rings w/locking-tabs
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Prefilter Material Mixed Cellulose Esters (MCE)
Quality Level MQ400
Biological Information
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Durapore® w/Prefilter
Sterility Other
Sterilization 10 SIP cycles of 30 min or 10 autoclave cycles of 60 min @ 121 °C
Wettability Hydrophilic
Physicochemical Information
Pore Size 0.45 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 Extractables The 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 Additive All 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 Releasing This 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 Endotoxins A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length 20 in. (50 cm)
Diameter 6.9 cm (2.7 in.)
Filtration Area 1.38 m²
Device Size 20 in.
Materials Information
Chemistry

Polyvinylidene Fluoride (PVDF)

Device Material

Polypropylene

Seal Material Silicone (SI)
Support Material Polypropylene
Packaging Information
Material Size 3
Material Package Double Easy-Open bag
Specifications
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
规格

OptiScale® and Millipak® Capsules
OptiScale® 25 Capsules OptiScale® 47 Capsules Millipak® 100 Millipak® 200
Nominal Dimensions
Maximum length: 39 mm (1.52 in.) with female Luer-Lok inlet/male Luer-Lok outlet 82 mm (3.24 in.) with flange inlet/hose barb outlet
74 mm (2.91 in.) with flange inlet/flange outlet
94 mm (3.70 in.) with hose barb inlet/hose barb outlet 13 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 Area 3.5 cm² 17.7 cm² 500 cm² (0.54 ft²) 1000 cm² (1.08 ft²)
Materials of Construction
Filter membrane: Hydrophilic polyvinylidene fluoride (PVDF)
Structural components: Polypropylene Polycarbonate
Supports: Polypropylene Polycarbonate
Vent caps: Polypropylene Polyvinylidene fluoride (PVDF)
Internal seal rings: Fluoroelastomers —
Housing Vent Capped 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 Pressure 4.1 bar (60 psig) at 25 °C 5.5 bar (80 psig) at 25 °C 5.2 bar (75 psig) at 25 °C
Maximum Differential Pressure
Forward: 4.1 bar (60 psig) at 25 °C 5.5 bar (80 psig) at 25 °C 4.1 bar (60 psid) at 25 °C
1.7 bar (25 psid) at 80 °C
345 mbar (5 psid) at 123 °C
Reverse: 0 bar (0 psig) 0.7 bar (10 psig) at 25 °C 690 mbar (10 psid) at 25 °C
Bubble Point at 23 °C — — ≥ 1790 mbar (26 psig) air with water
Gravimetric Extractables — — After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:
≤ 2.5 mg ≤ 5.0 mg
Bacterial Endotoxin Aqueous extraction contains — Aqueous extraction contains
Oxidizable Substances — Meets the requirements of the USP Oxidizable Substance Test after a water flush of:
≤ 100 mL 200 mL 200 mL
TOC/Conductivity This 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. —
Sterilization May be autoclaved for 1 cycle of 60 minutes at 123 °C May be autoclaved for 3 cycles of 60 minutes at 126 °C May 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 Practices These products are manufactured in a Millipore facility which adheres to FDA Device Good Manufacturing Practices.
Non-Fiber Releasing Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Component Material Toxicity Component 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 Additive The 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.