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CVGL01TP3 | Durapore® Cartridge Filter 10 in. 0.22 µm Code 0

CVGL01TP3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberCVGL01TP3
      Trade Name
      • Durapore®
      DescriptionDurapore® Cartridge Filter 10 in. 0.22 µm Code 0
      References
      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
      Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 25 °C
      Cartridge CodeCode 0 (2-222) O-rings
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      Sterilization30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Air Diffusion at 23 °C≤13.3 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate50 L/min @ 1.4 bar ΔP
      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).
      TOC/ConductivityAfter sterilization and a controlled water flush of 5.5 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      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 Length10 in. (25 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.69 m²
      Device Size10 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Durapore Cartridge
      Durapore Cartridge - C2PA14748
      Durapore Cartridge - C2SA19577
      Durapore Cartridge - C3AA40088
      Durapore Cartridge - C3BA46727
      Durapore Cartridge - C3BA49939
      Durapore Cartridge - C3BA52236
      Durapore Cartridge - C3CA78956
      Durapore Cartridge - C3CA88638
      Durapore Cartridge - C3DA92727
      Durapore Cartridge - C3DA98682
      Durapore Cartridge - C3EA06905
      Durapore Cartridge - C3EA25598
      Durapore Cartridge - C3JA73140
      Durapore Cartridge - C3KA95340
      Durapore Cartridge - C3MA15779
      Durapore Cartridge - C3PA43409
      Durapore Cartridge - C3SA80013
      Durapore Cartridge - C4AA12701
      Durapore Cartridge - C4BA89691
      Durapore Cartridge - C4CA31514
      Durapore Cartridge - C4DA38277
      Durapore Cartridge - C4DA50894
      Durapore Cartridge - C4EA60629
      Durapore Cartridge - C6BA14289
      Durapore Cartridge - C6DA40028
      Durapore Cartridge - C6DA59991
      Durapore Cartridge C4JA66593
      Durapore Cartridge C4NA07492
      Durapore Cartridge C4NA32098
      Durapore Cartridge C5CA74144
      Durapore Cartridge C5DA83599
      Durapore Cartridge C5EA93730
      Durapore Cartridge C5HA13033
      Durapore Cartridge C5JA35808
      Durapore Cartridge C5KA52709
      Durapore Cartridge C5NA62479
      Durapore Cartridge C5PA84438
      Durapore Cartridge C6JA80668
      Durapore Cartridge C6KA91365
      Durapore Cartridge/C4SA47256
      Durapore Cartridge/C5BA64476
      Durapore Hydrophilic Cartridge Filter - C0AA85128
      Durapore Hydrophilic Cartridge Filter - C0BA90553
      Durapore Hydrophilic Cartridge Filter - C0CA05449
      Durapore Hydrophilic Cartridge Filter - C0DA17795
      Durapore Hydrophilic Cartridge Filter - C0EA29860
      Durapore Hydrophilic Cartridge Filter - C0EA39088
      Durapore Hydrophilic Cartridge Filter - C0HA49061
      Durapore Hydrophilic Cartridge Filter - C0JA57631
      Durapore Hydrophilic Cartridge Filter - C0KA65174
      Durapore Hydrophilic Cartridge Filter - C0KA70485
      Durapore Hydrophilic Cartridge Filter - C0MA78182
      Durapore Hydrophilic Cartridge Filter - C0NA85918
      Durapore Hydrophilic Cartridge Filter - C0SA13663
      Durapore Hydrophilic Cartridge Filter - C1AA30888
      Durapore Hydrophilic Cartridge Filter - C1BA39616
      Durapore Hydrophilic Cartridge Filter - C1CA60679
      Durapore Hydrophilic Cartridge Filter - C1EA67267
      Durapore Hydrophilic Cartridge Filter - C1EA77335
      Durapore Hydrophilic Cartridge Filter - C1HA82793
      Durapore Hydrophilic Cartridge Filter - C1HA89045
      Durapore Hydrophilic Cartridge Filter - C1KA04243
      Durapore Hydrophilic Cartridge Filter - C1KA09737
      Durapore Hydrophilic Cartridge Filter - C1MA16686
      Durapore Hydrophilic Cartridge Filter - C1PA43296
      Durapore Hydrophilic Cartridge Filter - C1SA52204
      Durapore Hydrophilic Cartridge Filter - C1SA59827
      Durapore Hydrophilic Cartridge Filter - C2CA91400
      Durapore Hydrophilic Cartridge Filter - C2EA11252
      Durapore Hydrophilic Cartridge Filter - C2EA16669
      Durapore Hydrophilic Cartridge Filter - C2HA26567
      Durapore Hydrophilic Cartridge Filter - C2HA34775
      Durapore Hydrophilic Cartridge Filter - C2JA45106
      Durapore Hydrophilic Cartridge Filter - C2KA60074
      Durapore Hydrophilic Cartridge Filter - C9MN39873
      Durapore Hydrophilic Cartridge Filter - C9MN40475
      Durapore Hydrophilic Cartridge Filter - C9NN45593
      Durapore Hydrophilic Cartridge Filter - C9NN49417
      Durapore Hydrophilic Cartridge Filter - C9PN58613
      Durapore Hydrophilic Cartridge Filter - C9PN67372
      Durapore Hydrophilic Cartridge Filter - C9SN71135
      Durapore® Cartridge C6EA51600
      Durapore® Cartridge C5MA42480
      Durapore® Cartridge - C2SA20621
      Durapore® Cartridge - C4CA23405
      Durapore® Cartridge - C4KA85816
      Durapore® Hydrophilic Cartridge Filter - C0PA10147
      Durapore® Hydrophilic Cartridge Filter - C0PA98140
      Durapore® Hydrophilic Cartridge Filter - C1NA23149
      Durapore® Hydrophilic Cartridge Filter - C2BA84670
      Durapore® Hydrophilic Cartridge Filter - C2DA00136
      Durapore® Hydrophilic Cartridge Filter - C2DA04799
      Durapore® Hydrophilic Cartridge Filter - C2JA39788

      Data Sheet

      Title
      Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Hydrophilic Filters

      FAQ

      QuestionAnswer
      Can Durapore 0.22 micron cartridges be used in the reverse direction? Durapore filters are bidirectionally supported. If the filter is inadvertently used in the reverse direction, a post-use integrity test will identify whether or not the filter cartridge was integral during processing. The specification for theis filter is > 50.0 psi for a water bubble point test and < 13.3 ml/minute per 10"element for a diffusion test. If the filter passes this test, no damage occured during use.

      Please note that the maximum allowable pressure specification is different in the reverse direction - 50 psid vs. 80 psid in the forward direction.

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore