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CTGR01TP1

Aervent® 0.2 µm, Cartridge

Chemistry: 0.2 µm Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 10 in. Code 0

Synonym(s):

Aervent CTGR Cartridge Filter 10 in. 0.2 µm Code 0, Aervent® 0.2 µm, Cartridge

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

AERVENT® Cartridge, Chemistry: 0.2 µm Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 10 in. Code 0

Quality Segment

400

material

PTFE , polypropylene , polypropylene support, silicone seal

sterility

non-sterile

sterilization compatibility

steam-in-place compatible

product line

Aervent®

feature

hydrophobic

manufacturer/tradename

Aervent®

parameter

≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 °C (in 70/30% IPA/water), 1.7 bar max. inlet pressure (25 psi) at 80 °C, 1.8 bar max. differential pressure (25 psid) at 80 °C (Forward), 4.1 bar max. differential pressure (60 psid) (Reverse; intermittent), 4.1 bar max. inlet pressure (60 psi) (Reverse; Intermittent), 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

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

diam.

6.9 cm (2.7 in.)

filtration area

0.65 m2

impurities

<0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)

gravimetric extractables

≤35 mg/cartridge

matrix

Aervent®

pore size

0.2 μm pore size

input

sample type gas

bubble point

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

cartridge code

Code 0

General description

Device Configuration: Cartridge

Features and Benefits

Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °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: ≤0.75 mL/min @ 2.6 bar (38 psig) per 10 in cartridge
Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²

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.

Legal Information

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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