Millipak® Gold Filter MPGL04GK2

eCl@ss:	33050190
NACRES:	JA.14

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.
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.

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, and is considered to be a pesticide device under FIFRA . 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 10 CFU/cm using ASTM® F838 methodology.
Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature
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

Quality Level	400,
material	PVDF membrane
sterility	sterile
product line	EMPROVE® Filter
feature	hydrophilic
Торговая марка	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