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Merck
CN

CPGE73TP3

Millipore Express® PHF 0.2µm Cartridge 30

Code 7 Silicone, Autoclavable and SIP

别名:

Millipore Express® PHF，小柱

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UNSPSC Code:
23151806
eCl@ss:
32031690

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产品名称

Millipore Express PHF 筒式过滤器 30 in.0.2 µm 7 号 硅橡胶, pore size 0.2 μm, cartridge nominal length 30 in. (75 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

≤90 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

30 in.

W

2.7 in.

cartridge nominal length

30 in. (75 cm)

diam.

6.9 cm (2.7 in.)

filtration area

1.62 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

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 30 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 ≥3 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.

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).

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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