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KWSCA10FF1 Opticap® XL10 Milligard® 1.2/0.5 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWSCA10FF1
1  Double Easy-Open bag
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      概述

      Replacement Information
      Description
      Catalogue NumberKWSCA10FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Milligard® 1.2/0.5 µm 3/4 in. TC/TC
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 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
      European Pressure Equipment DirectiveEMD 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 Vessel Directive, this product does not bear the CE mark.
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      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 / 0.5 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 55 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 Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size1.2 / 0.5 µm
      Outlet Connection Diameter3/4 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 ≥5 L
      Global Trade Item Number
      产品目录编号 GTIN
      KWSCA10FF1 04053252491627

      Documentation

      Opticap® XL10 Milligard® 1.2/0.5 µm 3/4 in. TC/TC MSDS

      职位

      物料安全数据表 (MSDS) 

      质量证书

      标题
      Opticap XL 10 Capsule Milligard Media C7CA86650
      Opticap XL 10 Capsule Milligard Media C7EA07319
      Opticap XL 10 Capsule Milligard Media C7PA89838
      Opticap XL 10 Capsule Milligard Media - C0DB60701
      Opticap XL 10 Capsule Milligard Media C1KB51476
      Opticap XL 10 Capsule Milligard Media C2PB43514
      Opticap XL 10 Capsule Milligard Media C8SA65313
      Opticap XL 10 Capsule Milligard Media C9KA63417

      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

      相关产品和应用

      产品族

      Milligard® Capsule Filters

      Provide ease of use and convenience by eliminating the need for cartridge housing manipulations, and provide high retention efficiency.
      详细了解 >>

      Milligard® Capsule Filters

      Opticap® XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
      详细了解 >>

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      种类

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