KTGRA05TT1

Aervent^® 0.2 µm, Opticap^® XL Capsule

Opticap^® XL 5, inlet connection diam. 1.5 in., pore size 0.2 μm, cartridge nominal length 5 in. (13 cm)

• Synonym(s): Aervent KTGR Opticap XL5 Capsule, Aervent^® 0.2 µm, Opticap^® XL Capsule
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Properties

• Product Name: Opticap^® XL 5 CapsuleMedia: Aervent^® 0.2 µm, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeMax Operating Pressure: 80 psi @ 25 °C
• Quality Segment: 400
• material: PTFE , polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible
• product line: Opticap^® XL 5
• feature: hydrophobic
• manufacturer/tradename: Aervent^®
• parameter: ≤12 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: 21.6 cm (8.5 in.)
• W: 4.2 in.
• cartridge nominal length: 5 in. (13 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.32 m²
• inlet connection diam.: 1.5 in.
• inlet to outlet W: 21.6 cm (8.5 in.)
• outlet connection diam.: 1.5 in.
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• gravimetric extractables: ≤14 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, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

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
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: ≤0.38 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, 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.