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Merck
CN

CVEP72TE3

Millipore Express® SHR 0.1µm Cartridge 20

Code 7 EPDM, Autoclavable and SIP

别名:

Millipore Express® SHR，小柱

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UNSPSC Code:
23151806
eCl@ss:
32031690

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产品名称

Millipore Express SHR 筒式过滤器 20 in.0.1 µm 7 号 EPDM, pore size 0.1 μm, Code 7, EPDM rubber O-ring

material

polypropylene support
EPDM rubber O-ring
polyethersulfone membrane
polypropylene housing

Quality Level

400

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

Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

0.34 bar max. differential pressure (5 psi) at 135 °C
1 bar max. differential pressure (15 psi) at 135 °C
1.7 bar max. differential pressure (25 psi) at 80 °C
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse)
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
69 mbar max. differential pressure (1 psi) at 135 °C

device L

50.8 cm (20 in.)

filter diam.

13.8 cm (5.4 in.)

filtration area

1.2 m2 (13.0 ft2)

impurities

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

matrix

Millipore Express® SHR

pore size

0.1 μm pore size

input

sample type liquid

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C

cartridge code

Code 7

相关类别

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

General description

Device Configuration: Cartridge

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.

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).

Legal Information

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

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