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CHGE71TS

Millipore Express® SHC 0.5/0.2µm Cartridge 10

Code 7 Silicone, Autoclavable and SIP

Synonym(s):

Millipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690
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Product Name

Millipore Express® SHC, Cartridge, pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal

Quality Segment

400

material

polyethersulfone , polypropylene , polypropylene support, polysulfone , silicone seal

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible
steam-in-place compatible

product line

EMPROVE® Filter, Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤28.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water), 0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse), 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward), 1700 bar max. differential pressure (25 psi) at 80 °C (Forward), 2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse), 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse), 340 mbar max. differential pressure (5 psi) at 135 °C (Forward), 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse), 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward), 7 bar max. inlet pressure (100 psi) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

diam.

6.9 cm (2.7 in.)

filtration area

0.49 m2

impurities

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

matrix

Millipore Express® SHC

pore size

0.5/0.2 μm pore size

input

sample type liquid

bubble point

≥4000 mbar (58 psig), air with water at 23 °C

cartridge code

Code 7

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 autoclave cycles of 60 min @ 126 °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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 20 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

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 of Filters with MILLIPORE EXPRESS® Membrane user guide
  • Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane 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

ASTM is a registered trademark of American Society for Testing and Materials
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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Certificates of Analysis (COA)

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