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CTGB02TP3

Aerex® 0.2 µm, Cartridge

pore size 0.2 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

Synonym(s):

Aerex CTGB Cartridge Filter 20 in. 0.2 µm Code 0, Aerex® 0.2 µm, Cartridge

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Aerex® Cartridge, Chemistry: 0.2 µm Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 20 in. Code 0

Quality Segment

400

material

PTFE , polypropylene , polypropylene support, silicone seal

sterility

non-sterile

sterilization compatibility

steam-in-place compatible

product line

Aerex®

feature

hydrophobic

manufacturer/tradename

Aerex®

parameter

≤30 mL/min nitrogen diffusion at 690 mbar (10 psig) and 23 °C (in 60/40% IPA/water), 0.35 bar max. differential pressure (5 psid) at 145 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 145 °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), 5.2 bar max. differential pressure (75 psid) at 25 °C (Reverse; intermittent), 5.2 bar max. inlet pressure (75 psi) at 25 °C (Reverse), 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward), 7 bar max. inlet pressure (100 psi) at 25 °C (Forward)

technique(s)

gas filtration: suitable

L

20 in.

W

2.7 in.

cartridge nominal length

20 in. (50 cm)

diam.

6.9 cm (2.7 in.)

filtration area

1.3 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

≤70 mg/cartridge

matrix

Aerex®

pore size

0.2 μm pore size

input

sample type gas

bubble point

≥900 mbar (13 psig), nitrogen with 60/40% IPA/water at 23 °C

cartridge code

Code 0 (2-222; O-rings)

General description

Device Configuration: Cartridge

Features and Benefits

This product has been qualified to retain a ΦX174 virus aerosol challenge of 10⁸ to 10¹⁰ PFU at an air flow rate of 50 SCFM per 10-inch cartridge after 50 steam-in-place cycles at 145 °C.

Packaging

Easy-Open bag

Preparation Note

Sterilization Method
200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 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

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature
HydroCorr: ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig)
The membrane has been qualified to retain bacteria when challenged for 21 days with a minimum Brevundimonas diminuta aerosol concentration of 1 x 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.

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

Legal Information

AEREX is a registered trademark of Merck KGaA, Darmstadt, Germany

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Certificates of Analysis (COA)

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