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LAGRM1S02

Millipore

Aervent® 0.2 µm, Optiseal® Cartridge

pore size 0.2 μm, OptiSeal® 4 in., filtration area 0.05 m2, matrix Aervent®

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Synonym(s):
Optiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic
UNSPSC Code:
23151806
eCl@ss:
32031690

material

PTFE
polypropylene
polypropylene support
silicone seal

Quality Level

400

reg. compliance

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

OptiSeal® 4 in.

feature

hydrophobic

manufacturer/tradename

OptiSeal®

parameter

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)
4.1 bar max. differential pressure (60 psid) (Reverse)
4.1 bar max. inlet pressure (60 psi) (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)

gas filtration: suitable

cartridge nominal length

1 in. (2.5 cm)

filtration area

0.05 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

≤2.5 mg/cartridge

matrix

Aervent®

pore size

0.2 μm pore size

input

sample type liquid

bubble point

≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C

cartridge code

not applicable

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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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C
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

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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