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KTGRA04HH3 Millipore

Opticap Sterilizing Grade XL4 Aervent 0.2 µm 9/16 in. HB/HB

  •  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.   Opticap®
parameter   ≤9 mL/min nitrogen diffusion at 965 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
  2.8 bar max. inlet pressure (40 psi) at 60 °C
  25 °C max. inlet temp.
  4.1 bar max. differential pressure (60 psid) at 25 °C (Reverse; intermittent)
  5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
  5.5 bar max. inlet pressure (80 psi) at 23 °C
  80 psig max. inlet pressure
L   19.3 cm (7.6 in.)
cartridge nominal length   7.6 in. (19.3 cm)
diam.   8.4 cm (3.3 in.)
filtration area   0.21 m2
inlet connection diam.   9/16 in.
inlet to outlet W   19.3 cm (7.6 in.)
outlet connection diam.   9/16 in.
overall size   4 in.
impurities   <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables   ≤15 mg
matrix   Aervent®
pore size   0.2 μm pore size
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 hose barb
  14 mm (9/16 in.) inlet/outlet hose barb
  outlet hose barb

Description

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Linkage

Replaces: KTGP04HB3

Preparation Note

Sterilization Method
30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable

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: ≤0.25 mL/min @ 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.

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, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, 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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