material
PTFE
Quality Level
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.
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
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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