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CVGL75S01

Durapore^® 0.22 µm, Cartridge

Name: Durapore<SUP>®</SUP> 0.22 µm, Cartridge
Brand: MM

pore size 0.22 μm, cartridge nominal length 5 in. (12.5 cm), Code 7 (2-226; O-rings w/locking-tabs)

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Synonym(s):

Durapore Cartridge Filter 5 in. 0.22 μm Code 7

eCl@ss:

32031690

material

PVDF
polypropylene
polypropylene support
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

Durapore^®
EMPROVE^® Filter

feature

hydrophilic

manufacturer/tradename

Durapore^®

parameter

≤6.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
25 L/min flow rate at 1.4 bar (ΔP)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

L

5 in.

W

2.7 in.

cartridge nominal length

5 in. (12.5 cm)

diam.

6.9 cm (2.7 in.)

filtration area

0.35 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

≤10 mg/cartridge

matrix

Durapore^®

pore size

0.22 μm pore size

input

sample type liquid

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

cartridge code

Code 7 (2-226; O-rings w/locking-tabs)

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Final Sterile Filtration & Filling

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 for Filter Units with Durapore^® Membrane user guide
Storage Statement: Store in dry location
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C

This product was manufactured with a Durapore^® 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 were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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