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KVGLA05TH1 Opticap® XL5 Durapore® 0.22 µm 1-1/2 in. TC-9/16 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KVGLA05TH1
1  Double Easy-Open bag
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      概述

      Replacement Information
      Description
      Catalogue NumberKVGLA05TH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Durapore® 0.22 µm 1-1/2 in. TC-9/16 in. HB
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 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; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.4 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.
      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 ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤6.6 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 15 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 Length5 in. (12.5 cm)
      Length21.3 cm (8.4 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.35 m²
      Inlet to Outlet Width21.3 cm (8.4 in.)
      Device Size5 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter9/16 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 ≥500 mL
      Global Trade Item Number
      产品目录编号 GTIN
      KVGLA05TH1 04053252573538

      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 5 Capsule Durapore Membrane C2AB22951Z
      Opticap XL 5 Capsule Durapore Membrane C7MA35316
      Opticap XL 5 Capsule Durapore Membrane C8JA94055
      Opticap XL 5 Capsule Durapore Membrane C0AB41139
      Opticap XL 5 Capsule Durapore Membrane C0CB48239
      Opticap XL 5 Capsule Durapore Membrane C1SB07672Z
      Opticap XL 5 Capsule Durapore Membrane C3EB05893
      Opticap XL 5 Capsule Durapore Membrane C3JB35157
      Opticap XL 5 Capsule Durapore Membrane C7AA62051
      Opticap XL 5 Capsule Durapore Membrane C7EA94260
      Show more

      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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      0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes for sterile liquid filtration
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      种类

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