KTGRA02TH3

Aervent^® 0.2 µm, Opticap^® XL Capsule

inlet connection diam. 1.5 in., Opticap^® XL 2, pore size 0.2 μm, cartridge nominal length 2 in. (5 cm)

• Synonim(y): Opticap XL 2 with Aervent - 2" 0.2um TC/HB 3pk, Aervent^® 0.2 µm, Opticap^® XL Capsule
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: Opticap^® XL 2 CapsuleMedia: Aervent^® 0.2 µm, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi @ 25 °C
• Quality Segment: 400
• material: PTFE , polypropylene , polypropylene housing, polypropylene vent cap, silicone seal
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible
• product line: Opticap^® XL 2
• feature: hydrophobic
• manufacturer/tradename: Opticap^®
• parameter: 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.75 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 25 °C, 80 psig max. inlet pressure
• technique(s): gas filtration: suitable
• L: 5.6 in.
• W: 3.3 in.
• cartridge nominal length: 2 in. (5 cm)
• diam.: 8.4 cm (3.3 in.)
• filtration area: 0.1 m²
• inlet connection diam.: 1.5 in.
• outlet connection diam.: 9/16 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
• fitting: 1/4 in. drain/vent hose barb (with double O-ring Seal), (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Opis

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °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

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

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.

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