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KTGRA10FF1 Millipore

Aervent KTGR Opticap XL10 Capsule

  •  eCl@ss 32031690

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Properties

Quality Level   400
material   PTFE
  polypropylene
  polypropylene housing
  polypropylene support
  polypropylene vent cap
  silicone seal
feature   hydrophobic
mfr. no.   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
L   33.0 cm (13.0 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.
overall size   10 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   1/4 in. drain/vent hose barb (with double O-ring Seal)
  inlet sanitary flange
  19 mm (3/4 in.) inlet/outlet sanitary flange
  outlet sanitary flange

Description

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Quality

Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²

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

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

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.

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.
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