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LAGR04TP6

Optiseal® Cartridge Media: Aervent® 0.2 µm

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

Synonym(s):

Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic, Aervent® 0.2 µm, Optiseal® Cartridge

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

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

Quality Segment

400

material

PTFE , polypropylene , polypropylene support, silicone seal

sterility

non-sterile

sterilization compatibility

steam-in-place compatible

product line

OptiSeal® 4 in.

feature

hydrophobic

manufacturer/tradename

OptiSeal®

parameter

≤6 mL/min nitrogen diffusion at 965 mbar (14 psig) and 23 °C (in 70/30% IPA/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), 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

L

4 in.

cartridge nominal length

4 in. (10 cm)

filtration area

0.18 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

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

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave 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
HydroCorr: ≤0.20 mL/min with water @ 2.6 bar (38 psig)

Other Notes

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.

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

Legal Information

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

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Certificates of Analysis (COA)

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