MPGL04GK2

Millipak^® Gold Filter

Sterile 0.22 μm membrane filter for particulate-free and bacteria-free water at the point of dispense, For use with Alpha-Q, Milli-DI^® and Milli-Q^® Academic / Biocel / Element / Synthesis / Plus / Gradient systems

• Synonym(s): Millipak^® 40 Gamma Gold Filter
• UNSPSC Code: 41104212
• eCl@ss: 33050190
• NACRES: JA.14

Properties

• material: PVDF membrane
• Quality Level: 300
• sterility: sterile
• product line: EMPROVE^® Filter
• feature: hydrophilic
• packaging: pkg of 2 units
• manufacturer/tradename: Millipak^®
• parameter: 0.35 bar max. differential pressure at 123 °C (Forward); 0.7 bar max. differential pressure at 25 °C (Reverse); 1.7 bar max. differential pressure at 80 °C (Forward); 4.1 bar max. differential pressure at 25 °C (Forward); 5.2 bar max. inlet pressure at 25 °C
• inlet connection diam.: 1/4 in.
• outlet connection diam.: 1/4 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤1.5 mg/device
• matrix: Durapore^®
• pore size: 0.22 μm pore size
• fitting: male NPT inlet connection; outlet stepped hose barb (with bell)
• compatibility: for use with Alpha-Q; for use with Milli-DI^®; for use with Milli-Q^® Academic; for use with Milli-Q^® Biocel; for use with Milli-Q^® Direct; for use with Milli-Q^® Element; for use with Milli-Q^® Gradient; for use with Milli-Q^® Plus; for use with Milli-Q^® Reference; for use with Milli-Q^® Synthesis
• shipped in: ambient

Description

General description

Millipak^® membrane products are designed for routine filtration applications in the laboratory. Millipak^® filters are best-in-class proven products, used in lab water purification systems to provide particulate-free and bacteria-free water to benefit the stringent requirements of scientific applications.

Application

Provides bacteria- and particulate-free water suitable for techniques used in the laboratory where bacteria control is crucial (cell culture, microbiology media preparation, etc.).

Features and Benefits

• Millipak^® membrane filters are made with Durapore^® PVDF membranes to provide high flow rates and throughputs, low extractable and broad chemical compatibility.
• Gamma-irradiated for additional bacteria control.
• The membrane is supported by a rigid plastic disc with channels that ensures high water flow and resistance to pressure variations without the risk of membrane rupture.
• Millipak^® membrane filters use the unique, clean stacked disc design, allowing minimal hold-up volume and particle shedding.
• Connects to the outlet of the water delivery point, such as the PODs of Milli-Q^® water purification systems.The protective bell protects against intrusion of airborne bacteria contamination during dispensing.
• The protective bell protects against intrusion of airborne bacteria contamination during dispensing.
• Care-free maintenance: the filter is easily fitted and replaced.
• Device configuration: Gamma Gold Capsule.
• Sterile unit.
• Delivered hermetically sealed, with its Certificate of Quality.

Other Notes

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

Directions for Use

• Organism Retention: Microorganisms
• Mode of Action: Filtering
• Application: General laboratory analysis
• Intended Use: Water purification
• Instructions for Use: This item provides water filtered through 0.22 μm sterilizing-grade membranes. Refer to system equipment user guide section "Using the System" (available on USB key in the system box).
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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).

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

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

MILLI-DI is a registered trademark of Merck KGaA, Darmstadt, Germany

MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

Milli-Q is a registered trademark of Merck KGaA, Darmstadt, Germany