Skip to Content
Merck
CN

Key Documents

View All Documentation

MFGL10GL3

Millipak® Final Fill 100 Durapore®

Inlet: 1.5 in. Sanitary Flange Outlet: 1/2 in. Hose Barb Vent: 1/8 in. Hose Barb

Synonym(s):

Durapore® 0.22 µm, Millipak® Final Fill Capsule

Sign In to View Organizational & Contract Pricing.

Select a Size

Change View

About This Item

UNSPSC Code:
23151806
Technical Service
Need help? Our team of experienced scientists is here for you.
Let Us Assist

Product Name

Millipak® Final Fill 100 Durapore®, Inlet: 1.5 in. Sanitary Flange Outlet: 1/2 in. Hose Barb Vent: 1/8 in. Hose Barb

Quality Level

400

material

PVDF membrane, polysulfone device, polysulfone housing, polysulfone support, silicone O-ring

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

gamma compatible
x-ray compatible

product line

Millipak® Final Fill

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

filter diam.

8.1 cm (3.2 in.)

filter filtration area

500 cm2

impurities

<0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction)

matrix

Durapore®

pore size

0.22 μm pore size

bubble point

≥50 psi (3450 mbar), air with water at 23 °C

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet hose barb

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

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

Analysis Note

Bacterial Grow-Through: Quantitative retention of 1 x 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® F838 methodology.

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 general guidelines section of user guide shipped with this product
  • Storage Statement: Please refer user guide shipped with this product
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
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

Still not finding the right product?

Explore all of our products under Millipak® Final Fill 100 Durapore®

Regulatory Information

新产品

This item has

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
MFGL10GL304054839379697