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CPGE72TP48

Millipore Express® PHF 0.2µm Cartridge 20

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Code 7 Silicone, Autoclavable and SIP

Synonym(s):

Millipore Express® PHF Cartridge Filter 20 in. 0.2 µm Code 7 Silicone

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

Product Name

Millipore Express® PHF, Cartridge, pore size 0.2 μm, cartridge nominal length 20 in. (50 cm), silicone seal

material

polyethersulfone
polypropylene
polypropylene support
polysulfone
silicone seal

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

Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤60 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

20 in.

W

2.7 in.

cartridge nominal length

20 in. (50 cm)

diam.

6.9 cm (2.7 in.)

filtration area

1.08 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

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General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

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 20 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 =2 L

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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