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Key Documents

CGW171S03

Millipore

Polysep II 1,0/ 0,2/0,1 µm nominal, Cartucho

pore size 1.0/0.2/0.1 μm, cartridge nominal length 10 in. (25 cm)

Sinónimos:

Polysep II Cartridge Filter 10 in. 1.0/0.2/0.1 μm Code 7

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031610

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene
polypropylene support (Spun bonded)
silicone seal

Quality Level

reg. compliance

meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food)
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

Polysep

feature

hydrophilic

manufacturer/tradename

Polysep

parameter

3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C

technique(s)

prefiltration: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

diam.

7.1 cm (2.8 in.)

filtration area

0.42 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

Polysep II

pore size

1.0/0.2/0.1 μm nominal pore size
1.0/0.2/0.1 μm pore size

input

sample type liquid

cartridge code

Code 7

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General description

Device Configuration: Cartridge

Features and Benefits

Format: Triple Layer

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sanitization Protocol
30 min with hot water @ 80 °C
Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Legal Information

Polysep is a trademark of Sigma-Aldrich Co. LLC

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Pictograms

FlameHealth hazard

signalword

Danger

Hazard Classifications

Carc. 1B Inhalation - Flam. Sol. 1

Storage Class

4.1B - Flammable solid hazardous materials

wgk_germany

WGK 3


Certificados de análisis (COA)

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