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KTGRA10FF1

Aervent® 0.2 µm, Opticap® XL Capsule

Opticap® XL 10, hydrophobic, pore size 0.2 μm, non-sterile, 19 mm (3/4 in.) inlet/outlet sanitary flange, sterilization compatible with autoclavable

Synonyme(s) :

Aervent® 0.2 µm, Opticap® XL Capsule, Aervent KTGR Opticap XL10 Capsule

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A propos de cet article

eCl@ss:
32031690
UNSPSC Code:
23151806
Service technique
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Nom du produit

Aervent® 0,2 µm, capsule Opticap® XL, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE)Inlet: 3/4 in. Sanitary FlangeOutlet: 3/4 in. Sanitary FlangeMax Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

PTFE , polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 10

feature

hydrophobic

manufacturer/tradename

Aervent®

parameter

≤24 mL/min air diffusion at 965 mbar (14 psig) and 23 °C (in 70/30%IPA/water), ≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 °C (in 70/30% IPA/water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C (Forward), 2.8 bar max. inlet pressure (40 psi) at 60 °C (Forward), 25 °C max. inlet temp., 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), 80 psig max. inlet pressure

technique(s)

gas filtration: suitable

L

13.2 in.

W

4.2 in.

cartridge nominal length

10 in. (25 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.65 m2

inlet connection diam.

3/4 in.

inlet to outlet W

33.0 cm (13.0 in.)

outlet connection diam.

3/4 in.

impurities

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

gravimetric extractables

≤45 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

fitting

19 mm (3/4 in.) inlet/outlet sanitary flange

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
30 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: ≤0.75 mL/min @ 2.6 bar (38 psig) per sample
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
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. This product has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, this product does not bear the CE mark.

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RéférenceGTIN
KTGRA10FF104053252603686