MFGL04GF3

Millipak^® Final Fill 40 Durapore^®

Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange Vent: 1/8 in. Hose Barb

• Synonim(y): Millipak^® Final Fill 40, Durapore^® 0.22 µm, Millipak^® Final Fill Capsule
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: Millipak^® Final Fill 40 Durapore^®, Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange Vent: 1/8 in. Hose Barb
• Quality Segment: 400
• material: PVDF membrane, polysulfone device, polysulfone support, silicone O-ring
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: gamma compatible; x-ray compatible
• product line: Millipak^® Final Fill
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• packaging: bag of 3 × double easy-open bag
• parameter: 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
• technique(s): sterile filtration: suitable
• L: 3.4 in.
• W: 3.0 in.
• filter diam.: 7.6 cm (3.0 in.)
• filtration area: 200 cm²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Durapore^®
• pore size: 0.22 μm pore size
• bubble point: ≥50 psi (3450 mbar), air with water at 23 °C
• fitting: 19 mm (3/4 in.) inlet sanitary flange, 19 mm (3/4 in.) outlet sanitary flange

Opis

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 <nbsp/>°C. Devices can withstand a dose ? 40<nbsp/> kGy gamma exposure.

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.

Analysis Note

Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per AST F838 methodology.

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 general guidelines section of user guide shipped with this product
• Storage Statement: Please refer user guide shipped with this product
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.

Legal Information

ATCC is a registered trademark of American Type Culture Collection

Durapore 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.