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 Millidisk® Cartridge 10-stack 0.22 µm Hydrophilic


MCGL10S03 MilliporeMillidisk® Cartridge 10-stack
0.22 µm Hydrophilic
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MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other
available documents.

 Material Qualification Dossier


 Quality Management Dossier (Open Access)
 Technical Information
 Data Sheet
 CoQ
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MCGL10S03
3  Double Easy-Open bag
EUR 327.00
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«»
 Overview
 Supporting Documentation
 Related Products & Applications

Overview

 Description
 Product Information
 Biological Information
 Physicochemical Information
 Dimensions
 Materials Information
 Packaging Information
 Specifications
Description

Catalogue MCGL10S03
Number

Trade Name  Millidisk®

Description Millidisk® Cartridge 10-stack 0.22 µm Hydrophilic

Product Information

Device Cartridge
Configuration

Maximum Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C;
Differential Reverse: 0.7 bar (10 psid) @ 25 °C
Pressure, bar
(psid)

Maximum Inlet Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C;
Pressure, bar Reverse - 0.7 bar (10 psi) @ 25 °C
(psi)

Stack Design 10 Stak

Cartridge Code Not Applicable

Good These products are manufactured in a facility which adheres to FDA Good
Manufacturing Manufacturing Practices.
Practices

Quality Level MQ400


Biological Information

Bacterial Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte


Endotoxins Lysate (LAL) Test

Media Durapore®

Sterility Other

Sterilization 5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C

Bacterial Samples were quantitatively retentive of a minimum Brevundimonas


Retention diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.

Wettability Hydrophilic

Physicochemical Information

Pore Size 0.22 µm

Bubble Point at ≥3450 mbar (50 psig) air with water


23 °C

Flow Rate 15 L/min @ 3.5 bar ΔP

Gravimetric The extractables level was equal to or less than 2.5 mg per sterilized device after
Extractables 24 hours in water at controlled room temperature.

Non-Fiber This product was manufactured with a Durapore ® membrane which meets the criteria
Releasing for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Physicochemical Information

USP Bacterial A sample aqueous extraction contains less than 0.5 EU/mL as determined by the
Endotoxins Limulus Amebocyte Lysate (LAL) test.

Dimensions

Filtration Area 500 cm²

Materials Information

Chemistry  Polyvinylidene Fluoride (PVDF)

Device Material  Polysulfone

Seal Material Silicone (SI)

Support Polysulfone
Material

Packaging Information

Material Size 3

Material Double Easy-Open bag


Package

Specifications

Oxidizable Will meet the USP Oxidizable Substances Test requirements after a water flush of
Substances ≥200 mL

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