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PCC300C01 Pellicon® Capsule with Ultracel® Membrane, 300 kDa, C Screen, 0.1 m2

PCC300C01
1  
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Overview

Replacement Information
Description
Catalogue NumberPCC300C01
Trade Name
  • Pellicon®
DescriptionPellicon® Capsule with Ultracel® Membrane, 300 kDa, C Screen, 0.1 m2
References
Product Information
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.
NMWL300 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 Volume28 mL in feed channel
60 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 Area0.1 m2
Length13.9 in (35.3 cm)
Diameter1.5 in (3.8 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
Catalogue Number GTIN
PCC300C01 04065268798201

Documentation

Material Qualification Dossier

TitleVersion
6.0

Quality Management Dossier (Open Access)

Title

Certificates of Quality

Title
Pellicon Capsule Ultracel Membrane C2NB25755
Pellicon Capsule Ultracel Membrane C3DB13302
Pellicon Capsule Ultracel Membrane C3EB20440
Pellicon Capsule Ultracel Membrane C3HB30921
Pellicon Capsule Ultracel Membrane C3KB48205
Pellicon Capsule Ultracel Membrane C3PB52759
Pellicon Capsule Ultracel Membrane C3SB91975
Pellicon Capsule Ultracel Membrane C4BB05120
Pellicon Capsule Ultracel Membrane C4DB38790
Pellicon Capsule Ultracel Membrane C4EB49293