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CVSS72TP3

Multimedia Durapore® 0.5/0.2/0.22 µm, Cartridge

pore size 0.5/0.2/0.22 μm, cartridge nominal length 20 in. (50 cm), Code 7 (2-226; O-rings w/locking-tabs)

别名:

多介质Durapore® 0.5/0.2/0.22 µm，筒式

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eCl@ss:
32031690
UNSPSC Code:
23151806
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产品名称

Durapore 多介质筒式过滤器 20 in.0.5+0.2+0.22 µm 7 号, Chemistry: 0.5 / 0.2 / 0.22 µm Hydrophilic Mixed Cellulose Esters / Polyvinylidene Fluoride (MCE / PVDF)Configuration: 20 in. Code 7

Quality Level

400

material

PVDF , mixed cellulose esters (MCE) , mixed cellulose esters (MCE) prefilter, polypropylene , polypropylene support, 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

Durapore®

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

≤21.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward), 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent), 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse; Intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

L

20 in.

W

2.7 in.

cartridge nominal length

20 in. (50 cm)

diam.

6.9 cm (2.7 in.)

filtration area

1.12 m2

impurities

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

gravimetric extractables

≤140 mg/cartridge

matrix

Multimedia Durapore®

pore size

0.5/0.2/0.22 μm pore size

input

sample type liquid

bubble point

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

cartridge code

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

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
6 autoclave or SIP cycles of 30 min @ 123 °C
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
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥10 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 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

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存储类别

11 - Combustible Solids

wgk

WGK 2

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全球贸易项目编号

货号GTIN
CVSS72TP304053252340154