Millipore Sigma Vibrant Logo

MFGL02SC3 Gamma sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 3/4  in. TC - 1/4   in. HB

MFGL02SC3
3  Double Easy-Open bag
価格を検索中…
価格が見つかりません
Minimum Quantity needs to be mulitiple of
Maximum Quantity is
弊社照会 詳細を表示　
値引
()
 
—
弊社照会
—
現在国内在庫なし 現在国内在庫なし
現在国内在庫有り 
販売中止
在庫僅少
現在国内在庫あり
    Remaining : Will advise
      Remaining : Will advise
      注文対象外
      お問合せください
      Contact Customer Service

       

      お問合せください

      概要

      Replacement Information
      Description
      Catalogue NumberMFGL02SC3
      Trade Name
      • Millipak®
      DescriptionGamma sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 3/4  in. TC - 1/4   in. HB
      References
      Product Information
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet19  mm (¾  in.) sanitary flange inlet and 6  mm (¼  in.) hose barb outlet
      Maximum Differential Pressure, bar (psid)Forward:60 psi (4.1 bar) at 25 °C; 50 psi(3.5 bar) at 25 °C; (5 µm) 25 psi (1.7 bar) at 80 °C; Reverse: 10 psi (0.7 bar) at 25 °C
      Maximum Inlet Pressure, bar (psi)60 psi (4.1 bar) at 25 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      MediaDurapore®
      Sterilitysterilized by gamma irradiation
      SterilizationDevice integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤ 40  kGy gamma exposure.
      Bacterial RetentionQuantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate0.51 L/min @ 0.69 bar ΔP
      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), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections
      USP Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      Dimensions
      Filtration Area100 cm²
      Process Volume20 L
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter1/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polysulfone
      Support MaterialPolysulfone
      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
      Global Trade Item Number
      カタログ番号 GTIN
      MFGL02SC3 04054839378768

      Documentation

      Material Qualification Dossier

      タイトルバージョン
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      品質証明書

      タイトル
      Millipak Final Fill Capsule Durapore Membrane - C0EB52658
      Millipak Final Fill Capsule Durapore Membrane C3PB67070
      Millipak Final Fill Capsule Durapore membrane C3HB26330
      Millipak Final Fill Capsule Durapore membrane C4CB93433

      技術情報

      タイトル
      Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Reduce Contamination Risks and Simplify Filtration System Design and Operation

      データシート

      タイトル
      Durapore® Family Guide

      ユーザーガイド

      タイトル
      Wetting Instructions for Filter Units with Durapore Membrane

      関連製品＆アプリケーション

      製品ファミリー

      Millipak® Final Fill Filters

      Stacked disc filters designed to maximize recovery and enhance protection of your high value product
      詳細はこちら >>