It appears that your browser has JavaScript disabled.

This Website requires your browser to be JavaScript enabled.

Please enable JavaScript and reload this page.

Attention: We have moved. Merck Millipore products are no longer available for purchase on MerckMillipore.com.

MFVL02SH3 MilliporeGamma sterilized Millipak^® Final Fill 20 Filter Unit 0.1 µm 1/4 in. HB/HB

Produits recommandés

Aperçu

Replacement Information

Description
Catalogue Number	MFVL02SH3
Trade Name	Millipak^®
Description	Gamma sterilized Millipak^® Final Fill 20 Filter Unit 0.1 µm 1/4 in. HB/HB

References

Product Information
Device Configuration	Gamma Gold Capsule
Connections, Inlet/Outlet	6 mm (¼ in.) stepped hose barb inlet and outlet
Maximum Differential Pressure, bar (psid)	Forward:60 psi (4.1 bar) at 25 °C; 50 psi(3.5 bar) at 25 °C; (5 µm) 25 psi (1.7 bar) at 80 °C; Reverse: 10 psi (0.7 bar) at 25 °C
Maximum Inlet Pressure, bar (psi)	60 psi (4.1 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	sterilized by gamma irradiation
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.
Bacterial Retention	Quantitative retention of 10⁷CFU/cm² Brevundimonas diminuta ATCC^® 19146 per AST^® F838 methodology.
Wettability	Hydrophilic

Physicochemical Information
Pore Size	0.1 µm
Inlet Connection	Stepped Hose Barb
Outlet Connection	Stepped Hose Barb
Bubble Point at 23 °C	Please see Data Sheet
Flow Rate	0.17 L/min @ 0.86 bar ΔP
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	100 cm²
Process Volume	20 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
MFVL02SH3	04054839378447

Documentation

Material Qualification Dossier

Titre	Version
EMPROVE® Material Qualification Dossier - MFVL02SH3	1.0

Operational Excellence Dossier

Title
Gamma sterilized Millipak® Final Fill 20 Filter Unit 0.1 µm 1/4 in. HB/HB

Certificats de qualité

Titre
Millipak Final Fill Capsule Durapore Membrane C2HB31991
Millipak Final Fill Capsule Durapore Membrane C4EB43366
Millipak Final Fill Capsule Durapore Membrane- C3HB27860

Informations techniques

Titre
Integrity Test Troubleshooting - Beyond Rewet and Retest
Reduce Contamination Risks and Simplify Filtration System Design and Operation

Manuels d'utilisation

Titre
Wetting Instructions for Filter Units with Durapore Membrane

Produits & Applications associés

Familles de produits

Récemment consultés