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

PCC100C05
1  
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概述

Replacement Information
Description
Catalogue NumberPCC100C05
Trade Name
  • Pellicon®
DescriptionPellicon® Capsule with Ultracel® Membrane, 100 kDa, C Screen, 0.5 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.
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
产品目录编号 GTIN
PCC100C05 04065268796597

Documentation

Material Qualification Dossier

标题版本
6.0

Quality Management Dossier (Open Access)

Title

质量证书

标题
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

用户指南

标题
User Guide Pellicon® Capsule and Pellicon® Capsule Stand