MFGL06ST3

Millipak^® Final Fill 60 Durapore^®

Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb

• Synonym(e): Durapore^® 0.22 µm, Millipak^® Final Fill Capsule
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Durapore^®, 0,22 µm, Millipak^®-Kapsel für Endabfüllung, Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb
• Quality Segment: 400
• material: PVDF membrane, polysulfone housing, polysulfone support, silicone O-ring
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: sterile
• product line: Millipak^® Final Fill
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• 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
• filter diam.: 7.6 cm (3.0 in.)
• filter filtration area: 300 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: 38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

Beschreibung

General description

Device Configuration: Gamma Gold 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  °C. Devices can withstand a dose ≤40  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

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® 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

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

Legal Information

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

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