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KW19A3TTT1 Opticap® XLT30 Milligard® 1.2 µm 1-1/2 in. TC/TC

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KW19A3TTT1
1  Double Easy-Open bag
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      概述

      Replacement Information
      Description
      Catalogue NumberKW19A3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT30 Milligard® 1.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Filter GradeStandard Milligard® Media
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMilligard®
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size1.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 165 mg per capsule 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.
      Maximum Inlet Pressure (psig)80 psig
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a media combination 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 Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Filtration Area2.4 m²
      Inlet to Outlet Width15.2 cm (6.0 in.)
      Device Size30 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size1.2 µm
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥15 L
      Global Trade Item Number
      产品目录编号 GTIN
      KW19A3TTT1 04053252491528

      Documentation

      Opticap® XLT30 Milligard® 1.2 µm 1-1/2 in. TC/TC MSDS

      职位

      物料安全数据表 (MSDS) 

      质量证书

      标题
      Opticap XLT 30 Capsule Milligard Media C7PA89825
      Opticap XLT 30 Capsule Milligard Media C8DA35231
      Opticap XLT 30 Capsule Milligard Media C0AB79845
      Opticap XLT 30 Capsule Milligard Media C9MA86749
      Opticap XLT 30 Capsule Milligard Media - C8AA85147
      Opticap XLT 30 Capsule Milligard Media - C9DA20192
      Opticap XLT 30 Capsule Milligard Media - C9PA25981
      Opticap XLT 30 Capsule Milligard Media C1EB01510
      Opticap XLT 30 Capsule Milligard Media C1KB33356
      Opticap XLT 30 Capsule Milligard Media C2NB30269

      技术信息

      标题
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

      用户指南

      标题
      Opticap® XL Capsules and Opticap® XLT Capsules

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      种类

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard