MPGL02GF2

Millipak^® 20 Gamma Gold Capsule Media: Sterile Durapore^® 0.22 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange

• Synonim(y): Sterile Millipak-20 Filter Unit 0.22 μm 3/4 in. TC/TC, Durapore^® 0.22 µm, Millipak^® Capsule
• UNSPSC Code: 23151806
• NACRES: NB.24
• eCl@ss: 32031690

Właściwości

• Nazwa produktu: Millipak^® 20 Gamma Gold Capsule Media: Sterile Durapore^® 0.22 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange
• material: PVDF membrane, PVDF vent cap, polycarbonate , polycarbonate support
• product line: EMPROVE^® Filter
• feature: hydrophilic
• manufacturer/tradename: Millipak^®
• parameter: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward), 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.5 L/min flow rate at 1.75 bar (ΔP), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 10 L process volume, 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward), 5.2 bar max. inlet pressure (75 psi) at 25 °C
• technique(s): sterile filtration: suitable
• filtration area: 100 cm²
• inlet connection diam.: 3/4 in.
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤1 mg/device
• matrix: Durapore^®
• pore size: 0.22 μm
• bubble point: ≥3450 mbar (50 psig), air with water at 23 °C
• fitting: inlet sanitary flange, outlet sanitary flange, (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
• shipped in: ambient
• Quality Level: 400
• sterility: irradiated, sterile

Opis

General description

Device Configuration: Gamma Gold Capsule

Packaging

Blister

Preparation Note

Sterilization Method
3 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).

Analysis Note

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

Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature

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

Other Notes

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.

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

Legal Information

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

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

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

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

Ta strona może zawierać tekst przetłumaczony maszynowo.