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SGEPA25NB6

Millipore Express® SHF 0.2µm, OptiScale® 25mm Capsule

Fittings NB, Autoclavable

Synonym(s):

Millipore Express SHF Optiscale 25mm 0.2 μm NB

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690
NACRES:
NB.24
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Product Name

Millipore Express® SHF, OptiScale® Capsule, OptiScale®, filtration area 3.5 cm2

Quality Segment

400

material

polyethersulfone membrane, polypropylene support, polypropylene vent cap, polypropylene housing

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

OptiScale®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

0 bar max. differential pressure (0 psi) (Reverse), 4.1 bar max. inlet pressure (60 psi) at 25 °C, 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)

technique(s)

sterile filtration: suitable

cartridge nominal length

1.52 in. (39 mm)

device L

39 mm (1.52 in.)

filter diam.

31 mm (1.2 in.)

filtration area

3.5 cm2

impurities

<0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Millipore Express® SHF

pore size

0.2 μm

fitting

female Luer-Lok® inlet connection, male Luer-Lok® outlet connection, (Female Luer-Lok® Inlet/Male Luer Slip Outlet)

General description

Device Configuration: Capsule

Preparation Note

Sterilization Method
1 autoclave cycle of 60 min @ 123 °C
This product was manufactured with a Millipore Express membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
This product was tested and passes the USP <78> test for particulates in injectables.

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 installation and wetting sections of OPTISCALE®-25 user guide
  • Storage Statement: Please refer to OPTISCALE®-25 user guide
  • 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

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany

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’.

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