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Merck
CN

MPVL20CF3

可γ辐照 Millipak -200 过滤单元 0.1 µm 3/4 in.TC/TC

Millipak® 200, filtration area 1000 cm2, matrix Durapore®

别名:

Millipak®囊式过滤器，带Durapore® 0.1 µm滤膜

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UNSPSC Code:
23151806

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产品名称

可γ辐照 Millipak -200 过滤单元 0.1 µm 3/4 in.TC/TC, Millipak® 200, filtration area 1000 cm2, matrix Durapore®

material

PVDF
PVDF vent cap
polycarbonate
polycarbonate support

sterility

irradiated
non-sterile

sterilization compatibility

gamma compatible
gamma compatible

product line

Millipak® 200

feature

gamma compatible
hydrophilic

manufacturer/tradename

Millipak®

parameter

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward)
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
100 L process volume
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
5.2 bar max. inlet pressure (75 psi) at 25 °C
8.5 L/min flow rate at 2.45 bar (ΔP)

technique(s)

sterile filtration: suitable

L

6.0 in.

W

3.0 in.

diam.

7.6 cm (3.0 in.)

filtration area

1000 cm2

inlet connection diam.

3/4 in.

outlet connection diam.

3/4 in.

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

≤5 mg/device

matrix

Durapore®

pore size

0.1 μm

bubble point

≥4830 mbar (70 psig), air with water at 23 °C

fitting

inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Quality Level

400

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.
使用 ≥200 mL 水冲洗后，将符合“USP 氧化物检测”要求
Gravimetric Extractables: after 24 hours in water at controlled room temperature

General description

Device Configuration: 取样皿滤膜

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.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
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).

Legal Information

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

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