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CGW6M4S03

Millipore

Polysep™ II 1.0/0.5 µm nominal, Cartridge

pore size 1.0/0.5 μm, cartridge nominal length 4 in. (10 cm), Code M (2-118; O-rings)

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Synonym(s):
Polysep II Cartridge Filter 4 in. 0.5 μm Code M
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

400

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

4 in.

W

2.7 in.

cartridge nominal length

4 in. (10 cm)

diam.

7.1 cm (2.8 in.)

filtration area

0.19 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

≤56 mg/cartridge

matrix

Polysep™ II

pore size

1.0/0.5 μm nominal pore size
1.0/0.5 μm pore size

input

sample type liquid

cartridge code

Code M (2-118; O-rings)

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General description

Device Configuration: Cartridge

Features and Benefits

Format: Double 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 ≥2 L

Legal Information

Polysep is a trademark of Sigma-Aldrich Co. LLC

Pictograms

Flame
GHS02

Signal Word

Danger

Hazard Statements

H228

Hazard Classifications

Flam. Sol. 1

WGK

WGK 2

Regulatory Information

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