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LAGR04TP1

Optiseal® Cartridge Media: Aervent® 0.2 µm

Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 4 in.

Synonym(s):

Optiseal® 0.2 µm 4′ Cartridge, Aervent® 0.2 µm, Optiseal® Cartridge

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About This Item

eCl@ss:
27293007
UNSPSC Code:
23151806
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Product Name

Optiseal® Cartridge Media: Aervent® 0.2 µm, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 4 in.

material

PTFE

Quality Level

400

sterility

non-sterile

sterilization compatibility

steam-in-place compatible

product line

OptiSeal® 4 in.

feature

hydrophobic

technique(s)

gas filtration: suitable

cartridge nominal length

4 in.

impurities

<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤10 mg/cartridge

matrix

Aervent®

pore size

0.2 μm pore size

cartridge code

not applicable

General description

Device Configuration: Cartridge

Preparation Note

This product was manufactured with a PTFE 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 a 70/30% IPA/water mixture at controlled room temperature

Other Notes

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

Legal Information

AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
OPTISEAL is a registered trademark of Merck KGaA, Darmstadt, Germany

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Certificates of Analysis (COA)

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Global Trade Item Number

SKUGTIN
LAGR04TP104053252819896