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MPGL20CF3 Gamma Compatible Millipak®-200 Filter Unit 0.22 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MPGL20CF3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

概述

Replacement Information
Description
Catalogue NumberMPGL20CF3
Trade Name
  • Millipak®
DescriptionGamma Compatible Millipak®-200 Filter Unit 0.22 µm 3/4 in. TC/TC
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)5.2 bar (75 psi) @ 25 °C
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 90 min @ 123°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 ConnectionSanitary Flange
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Flow Rate19 L/min @ 3.2 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 5 mg per device after 24 hours in water at controlled room temperature.
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
Length13.0 cm (5.1 in.)
Diameter7.6 cm (3.0 in.)
Filtration Area1000 cm²
Process Volume100 L
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polycarbonate
Support MaterialPolycarbonate
Vent Cap MaterialPolyvinylidene fluoride (PVDF)
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
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Global Trade Item Number
产品目录编号 GTIN
MPGL20CF3 04053252456183

Documentation

Operational Excellence Dossier

Title

质量证书

标题
Millipak 200 Capsule Durapor Membrane C1BB08108Z
Millipak 200 Capsule Durapore Membrane C0AB87104
Millipak 200 Capsule Durapore Membrane C0EB74426
Millipak 200 Capsule Durapore Membrane C0KB03167
Millipak 200 Capsule Durapore Membrane C0NB33018
Millipak 200 Capsule Durapore Membrane C0PB46619
Millipak 200 Capsule Durapore Membrane C1EB04444Z
Millipak 200 Capsule Durapore Membrane C1EB85738Z
Millipak 200 Capsule Durapore Membrane C2JB28490Z
Millipak 200 Capsule Durapore Membrane C2PB36915Z
Show more

技术信息

标题
Best Practices for Managing Reverse Pressure Filter Impact
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest
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
Wetting Instructions for Filter Units with Durapore Membrane