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MFSL06GH3 MilliporeNon-sterilized Millipak^® Final Fill 60 Filter Unit 5.0 µm 1/4 in. HB/HB

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Aperçu

Replacement Information

Description
Catalogue Number	MFSL06GH3
Trade Name	Millipak^®
Description	Non-sterilized Millipak^® Final Fill 60 Filter Unit 5.0 µm 1/4 in. HB/HB

References

Product Information
HS Code	8421 29 90
Device Configuration	Capsule
Connections, Inlet/Outlet	6 mm (¼ in.) stepped hose barb inlet and outlet
Maximum Differential Pressure, bar (psid)	Foward:80 psi (5.5 bar) at 25 °C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm); Reverse: 10 psi (0.7 bar) at 25 °C
Maximum Inlet Pressure, bar (psi)	80 psi (5.5 bar) at 25 °C
Good Manufacturing Practices	These products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
Quality Level	MQ400

Applications

Biological Information
Bacterial Endotoxins	Aqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
Media	Durapore^®
Sterility	non-sterilized
Sterilization	Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 °C. Devices can withstand a dose ≤ 40 kGy gamma exposure.
Wettability	Hydrophilic

Physicochemical Information
Pore Size	5.0 µm
Inlet Connection	Stepped Hose Barb
Outlet Connection	Stepped Hose Barb
Bubble Point at 23 °C	≥ 2.0 psi (138 mbar) air with water
Flow Rate	4.5 L/min @ 0.69 bar ∆P
Non-Fiber Releasing	This 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), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections
USP Bacterial Endotoxins	Aqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.

Dimensions
Filtration Area	300 cm²
Process Volume	60 L
Inlet Connection Diameter	1/4 in.
Outlet Connection Diameter	1/4 in.

Materials Information
Chemistry	Polyvinylidene Fluoride (PVDF)
Device Material	Polysulfone
Support Material	Polysulfone

Toxicological Information

Safety Information according to GHS

Safety Information

Product Usage Statements

Storage and Shipping Information

Packaging Information
Material Size	3
Material Package	Double Easy-Open bag

Transport Information

Supplemental Information

Specifications

Global Trade Item Number
Référence	GTIN
MFSL06GH3	04054839378409

Documentation

Material Qualification Dossier

Titre	Version
EMPROVE® Material Qualification Dossier - MFSL06GH3	1.0

Operational Excellence Dossier

Title
Non-sterilized Millipak® Final Fill 60 Filter Unit 5.0 µm 1/4 in. HB/HB

Certificats de qualité

Titre
Millipak Final Fill Capsule Durapore Membrane C0HB68834
Millipak Final Fill Capsule Durapore Membrane C2EB66424
Millipak Final Fill Capsule Durapore Membrane C4HB35148

Informations techniques

Titre
Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest
Reduce Contamination Risks and Simplify Filtration System Design and Operation

Fiche technique

Titre
Durapore® Family Guide

Manuels d'utilisation

Titre
Wetting Instructions for Filter Units with Durapore Membrane

Produits & Applications associés

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