MFGL10SL3

Durapore^®, 0,22 µm, Millipak^®-Kapsel für Endabfüllung

Millipak^® Final Fill 100, sterile; γ-irradiated

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: polysulfone device; polysulfone support
• Qualitätsniveau: 400
• Agentur: meets EP 2.6.14; meets JP 4.01; meets USP 85
• Sterilität: irradiated; sterile; γ-irradiated
• Produktlinie: Millipak^® Final Fill 100
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipak^®
• Parameter: 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 100 L process volume; 3.81 L/min flow rate at 1.1 bar (ΔP); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• Methode(n): sterile filtration: suitable
• Filtrationsfläche des Filters: 500 cm²
• Verunreinigungen: <0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
• Matrix: Durapore^®
• Porengröße: 0.22 μm pore size
• Blasenpunkt: ≥50 psi (3450 mbar), air with water
• Fitting: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Gamma Gold Capsule

Verpackung

Double Easy-Open bag

Angaben zur Herstellung

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

Hinweis zur Analyse

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

Sonstige Hinweise

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.

Rechtliche Hinweise

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