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Merck
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CPGE71TP

Millipore Express® PHF 0.2µm Cartridge 10

Code 7 Silicone, Autoclavable and SIP

别名:

Millipore Express® PHF Cartridge Filter 10 in. 0.2 µm Code 7 Silicone

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UNSPSC Code:
23151806
eCl@ss:
32031690

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产品名称

Millipore Express® PHF，小柱, pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal

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

Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤30 mL/min air diffusion at 2.76 bar (40 psig) and 23 °C (in water), 0.07 bar max. differential pressure (1 psid) at 135 °C (Reverse), 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 1.0 psi max. differential pressure (69 mbar) at 135 °C (Reverse), 1.4 bar max. differential pressure (20 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 20 psi max. differential pressure (1.4 bar) at 25 °C (Reverse), 25 psi max. differential pressure (1.7 bar) at 80 °C (Forward), 5.0 psi max. differential pressure (340 mbar) at 135 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

technique(s)

bioburden reduction: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

diam.

6.9 cm (2.7 in.)

filtration area

0.54 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® PHF

pore size

0.2 μm pore size

input

sample type liquid

cartridge code

Code 7

Quality Level

400

相关类别

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
12 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 15 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 of membrane used in this filter 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 10 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 ≥1 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
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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