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KVGLA1THH1 Opticap® XLT10 Durapore® 0.22 µm 5/8 in. HB/HB

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KVGLA1THH1
1  Double Easy-Open bag
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      概述

      Replacement Information
      Description
      Catalogue NumberKVGLA1THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT10 Durapore® 0.22 µm 5/8 in. HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 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.
      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
      MediaDurapore®
      SterilityOther
      Sterilization3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
      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
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      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
      Gravimetric ExtractablesThe extractables level was equal to or less than 25 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 Durapore® membrane 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)
      Length37.6 cm (14.8 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size10 in.
      Inlet Connection Diameter5/8 in.
      Outlet Connection Diameter5/8 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      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 ≥1 L
      Global Trade Item Number
      产品目录编号 GTIN
      KVGLA1THH1 04053252570940

      Documentation

      Material Qualification Dossier

      标题版本
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      质量证书

      标题
      OPTICAP XL 10 Capsule Durapore Membrane C4KB68174
      OPTICAP XLT 10 Capsule Durapore Membrane C4MB84514
      Opticap XLT 10 Capsule Durapore Membrane C9KA75678
      Opticap XLT 10 Capsule Durapore Membrane - C0BB00248Z
      Opticap XLT 10 Capsule Durapore Membrane - C7DA97618
      Opticap XLT 10 Capsule Durapore Membrane - C7DA98022
      Opticap XLT 10 Capsule Durapore Membrane -C8NA15553
      Opticap XLT 10 Capsule Durapore Membrane C0KB01782Z
      Opticap XLT 10 Capsule Durapore Membrane C1HB13459
      Opticap XLT 10 Capsule Durapore Membrane C2AB23446

      技术信息

      标题
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      数据表

      标题
      Durapore® Family Guide

      用户指南

      标题
      Opticap® XL Capsules and Opticap® XLT Capsules

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      种类

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