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PCC100C05 Pellicon® Capsule with Ultracel® Membrane, 100 kDa, C Screen, 0.5 m2

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PCC100C05
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      Overview

      Replacement Information
      Description
      Catalogue NumberPCC100C05
      Trade Name
      • Pellicon®
      DescriptionPellicon® Capsule with Ultracel® Membrane, 100 kDa, C Screen, 0.5 m2
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/OutletFeed: 3/4" Sanitary Flange
      Retentate: 3/4" Sanitary Flange
      Permeate: 3/4" Sanitary Flange
      Filter TypeUltrafiltration
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to Good Manufacturing Practices.
      NMWL100 kDa
      Quality LevelMQ400
      Applications
      Key Applications
      • Viral Gene Therapies
      • Vaccines
      • Concentration
      • Diafiltration
      • Buffer Exchange
      • mRNA
      Biological Information
      MediaUltracel®
      Sterilitysterilized by gamma irradiation
      Physicochemical Information
      Flow Rate RangeFeed: 4 – 6 L/min per m2
      pH RangepH 2 - 13
      Hold-up Volume118 mL in feed channel
      133 mL in permeate channel
      Screen TypeType C screen (coarse screen)
      Maximum Operating Temperature and PressureInlet Pressure: 80 psi (5.5 bar) at 4-30°C
      Forward Transmembrane Pressure (TMP): 45 psi (3.1 bar) at 4-30°C
      Dimensions
      Membrane Area0.5 m2
      Length13.9 in (35.3 cm)
      Diameter2.3 in (5.7 cm)
      Materials Information
      Chemistry
      • Composite Regenerated Cellulose (CRC)
      Device Material
      • Housing/Core: PPO/PS Blend
        Potting: BPA-free Epoxy, Polyurethane
      Screen Material
      • Polypropylene (PP)
      • Polyester
      Seal MaterialEPDM, Thermoplastic Elastomer
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Storage Temperature15-30°C
      Packaging Information
      Material Size1
      Transport Information
      Supplemental Information
      Specifications
      TOCMeets TOC ≤ 5 ppm in retentate effluent, after a WFI flush of 20 L/m2
      Global Trade Item Number
      Catalog Number GTIN
      PCC100C05 04065268796597

      Documentation

      Material Qualification Dossier

      TitleVersion
      6.0

      Quality Management Dossier (Open Access)

      Title

      Certificates of Quality

      Title
      Pellicon Capsule Ultracel Membrane C3MB52758
      Pellicon Capsule Ultracel Membrane C2NB25762
      Pellicon Capsule Ultracel Membrane C3HB31839
      Pellicon Capsule Ultracel Membrane C4JB68041
      Pellicon Capsule Ultracel Membrane C4KB76432
      Pellicon Capsule Ultracel Membrane C4NB99522