MPGL1GCF3

Durapore^® 0.22 µm, Millipak^® Capsule

sterile

• Synonym(s): Sterile Millipak -100 Filter Unit 0.22 μm 3/4 in. TC/TC
• UNSPSC Code: 23151806

Properties

• material: PVDF ; PVDF vent cap; polycarbonate ; polycarbonate support
• Quality Level: 400
• sterility: irradiated; sterile
• product line: EMPROVE^® Filter; Millipak^®
• 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); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 11 L/min flow rate at 2.8 bar (ΔP); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 50 L process volume
• technique(s): sterile filtration: suitable
• filtration area: 500 cm²
• inlet connection diam.: 3/4 in.
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤2.5 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)

Description

General description

Device Configuration: Gamma Gold Capsule

Packaging

Blister

Other Notes

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

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.

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

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