MILLIPAK 200 0.22UM 3/PK

Code: MPGL20CA3 D2-231

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Bacterial RetentionSamples were quantitatively retentive of a minimum

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€938.60 EACH
Discontinued
€1,154.48 inc. VAT

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.

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

General description

Device Configuration: Capsule

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

Other Notes

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

Directions for Use Organism Retention: Microorganism Mode of Action: Filtration (size exclusion) Application: BioProcessing Intended Use: Reduction or removal of microorganism/bioburden Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide Storage Statement: Store in dry location Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable

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).

bubble point≥3450 mbar (50 psig), air with water at 23 °C
diam.7.6 cm (3.0 in.)
featurehydrophilic, gamma compatible
filtration area1000 cm2
fitting14 mm (9/16 in.) inlet/outlet hose barb, outlet hose barb, inlet hose barb
gravimetric extractables≤5 mg/device
impurities≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), ﹤0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
inlet connection diam.9/16 in.
L13.0 cm (5.1 in.)
manufacturer/tradenameMillipak®
materialpolycarbonate support, polycarbonate, PVDF vent cap, PVDF
matrixDurapore®
outlet connection diam.9/16 in.
parameter0.35 bar max. differential pressure (5 psid) at 123 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 100 L process volume, 19 L/min flow rate at 2.8 bar (δP), 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 5.2 bar max. inlet pressure (75 psi) at 25 °C, 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
pore size0.22 µm pore size, 0.22 µm nominal pore size
product lineEMPROVE® Filter
Quality Level400
This product has met the following criteria to qualify for the following awards:



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