默克Millipore密理博Durapore滤芯CVHL72TP3


品牌 其他品牌

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.
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 ¼ 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.

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