默克Millipore密理博Durapore濾芯CVHL72TP3 CVGL72TP3 CTGR71TP1
有效去除膠體和顆粒污染物。Durapore濾芯在制造過程中進(jìn)行了100%的完整性測試，以確保完整性。Durapore親水濾芯由聚偏氟乙烯(PVDF)膜與纖維素酯(RW06)預(yù)過濾層制造，更大的通量和聚丙烯組件，廣泛的化學(xué)相容性。
| Description | |
|---|---|
| Catalogue Number | CVHL72TP3 |
| Trade Name |
|
| 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 |
|
| Device Material |
|
| 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 |
規(guī)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. | |||
| Opticap® XL Capsules and Cartridge Filters | |||||
| Opticap® XL 2 | Opticap® XL 4 | Opticap® XL 5 | Opticap® XL 10 | Cartridge (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 Area | 0.09 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/Drain | ? in. hose barb with double O-ring seal | — | |||
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 23 °C 2.8 bar (40 psi) at 60 °C 1.0 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 °C 1.8 bar (25 psid) at 80 °C 345 mbar (5 psid) at 135 °C | |||
| Reverse: | 3.4 bar (50 psid) at 25 °C, intermittent | 3.5 bar (50 psid) at 25 °C, intermittent | |||
| Bubble Point at 23 °C | ≥ 1930 mbar (28 psig) air with water | ||||
| Air Diffusion | Through 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 Extractables | After 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 Endotoxin | Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||||
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substance Test after a water flush of: | ||||
| 500 mL | 1000 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 °C | 30 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)/Conductivity | Autoclaved 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 Practices | These products are manufactured in a Millipore facility which adheres to FDA 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 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 Additive | Durapore 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 Directive | Millipore 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濾芯CVHL72TP3 CVGL72TP3 CTGR71TP1
