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MSP000812

Durapore® Cartridge

Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 10 in. Code 7

别名:

Durapore® 0.22 µm，小柱

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eCl@ss:
27293007
UNSPSC Code:
23151806
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产品名称

Durapore 筒式过滤器 10 in.0.22 µm 7 号, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 10 in. Code 7

material

PVDF

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

Durapore®, EMPROVE® Filter

feature

hydrophilic

manufacturer/tradename

Durapore®

technique(s)

sterile filtration: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

filtration area

0.69 m2

impurities

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

gravimetric extractables

≤20 mg/cartridge

matrix

Durapore®

pore size

0.22 μm

input

sample type liquid

cartridge code

Code 7 (2-226; O-rings w/locking-tabs)

General description

Device Configuration: Cartridge

Preparation Note

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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature

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

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

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全球贸易项目编号

货号GTIN
MSP00081204053252562839