Skip to Content
Merck
CN

Key Documents

View All Documentation

MPHL02GF2

Millipak® 20 Gamma Gold Capsule Media: Sterile Durapore® 0.45 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange

Synonym(s):

Sterile Millipak-20 Filter Unit 0.45 μm 3/4 in. TC/TC, Durapore® 0.45 µm, Millipak® Capsule

Sign In to View Organizational & Contract Pricing.

Select a Size

Change View

About This Item

UNSPSC Code:
23151806
NACRES:
NB.24
eCl@ss:
32031690
Technical Service
Need help? Our team of experienced scientists is here for you.
Let Us Assist

Product Name

Millipak® 20 Gamma Gold Capsule Media: Sterile Durapore® 0.45 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange

Quality Level

400

material

PVDF membrane, PVDF vent cap, polycarbonate , polycarbonate support

sterility

irradiated, sterile

product line

Millipak® 20

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), 10 L process volume, 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward), 5.2 bar max. inlet pressure (75 psi) at 25 °C, 6.4 L/min flow rate at 2.45 bar (ΔP)

technique(s)

bioburden reduction: suitable

filtration area

100 cm2

inlet connection diam.

3/4 in.

outlet connection diam.

3/4 in.

impurities

≤0.5 EU/mL (LAL test, Aqueous extraction), <0.5  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤1 mg/device

matrix

Durapore®

pore size

0.45 μm

bubble point

≥1790 mbar (26 psig), air with water at 23 °C

fitting

inlet sanitary flange, outlet sanitary flange, (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

shipped in

ambient

General description

Device Configuration: Gamma Gold Capsule
Number of stacked discs: 20 discs

Packaging

Blister

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

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

Other Notes

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.

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

Legal Information

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

Still not finding the right product?

Explore all of our products under Millipak® 20 Gamma Gold Capsule Media: Sterile Durapore® 0.45 µm

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library

Global Trade Item Number

SKUGTIN
MPHL02GF204053252246579