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MFGL10SB3 MilliporeGamma sterilized Millipak^® Final Fill 100 Filter Unit 0.22 µm 1/2 in. HB/HB

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Overview

Replacement Information

Description
Catalogue Number	MFGL10SB3
Trade Name	Millipak^®
Description	Gamma sterilized Millipak^® Final Fill 100 Filter Unit 0.22 µm 1/2 in. HB/HB

References

Product Information
HS Code	8421 29 90
Device Configuration	Gamma Gold Capsule
Connections, Inlet/Outlet	13 mm (½ 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	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	0.22 µm
Inlet Connection	Stepped Hose Barb
Outlet Connection	Stepped Hose Barb
Bubble Point at 23 °C	≥ 50 psi (3450 mbar) air with water
Flow Rate	3.81 L/min @ 1.1 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	500 cm²
Process Volume	100 L
Inlet Connection Diameter	1/2 in.
Outlet Connection Diameter	1/2 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
Catalogue Number	GTIN
MFGL10SB3	04054839378546

Documentation

Material Qualification Dossier

Title	Version
EMPROVE® Material Qualification Dossier - MFGL10SB3	1.0

Quality Management Dossier (Open Access)

Title
Gamma sterilized Millipak® Final Fill 100 Filter Unit 0.22 µm 1/2 in. HB/HB

Operational Excellence Dossier

Title
Gamma sterilized Millipak® Final Fill 100 Filter Unit 0.22 µm 1/2 in. HB/HB

Certificates of Quality

Title
Millipak Final Fill Capsule Durapore Membrane C3PB71295
Millipak Final Fill Capsule Durapore Membrane - C0AB19525
Millipak Final Fill Capsule Durapore Membrane C2JB31929
Millipak Final Fill Capsule Durapore membrane C4NB02232

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