MFGL04GF3

Millipak^® Final Fill 40

non-sterile (non-sterilized), pore size 0.22 μm

• Synonym(s): Millipak-40 Capsule Filter Unit

Properties

• material: PVDF membrane; polysulfone device; polysulfone support
• Quality Level: 400
• Agency: certified by the ISO 9001:2015 (Quality Management Systems); meets requirements for EP 2.6.14; meets requirements for JP 4.01; meets requirements for USP 85
• sterility: non-sterile (non-sterilized)
• feature: hydrophilic
• packaging: bag of 3 × double easy-open bag
• parameter: 1.0 L/min flow rate at 0.69 bar; 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 25 °C (Forward); 50 psi max. differential pressure (3.5 bar) at 25 °C (Forward); 60 psi max. differential pressure (4.1 bar) at 25 °C (Forward); 60 psi max. inlet pressure (4.1 bar) at 25 °C; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward); 80 psi max. inlet pressure (5.5 bar) at 25 °C
• filtration area: 200 cm²
• impurities: <0.25 EU/mL bacterial endotoxins (LAL test)
• matrix: Durapore^®
• pore size: 0.22 μm pore size
• bubble point: ≥50 psi (3450 mbar), air with water at 23 °C
• fitting: 3/4 in. inlet connection; 19 mm (3/4 in.) inlet/outlet connection (sanitary flange)

Description

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

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.

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.

Analysis Note

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

Other Notes

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