KTGRA10FF1

Aervent^® 0.2 µm, Opticap^® XL Capsule

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

• Synonim(y): Aervent KTGR Opticap XL10 Capsule
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: PTFE ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Poziom jakości: 400
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible
• linia produktu: Opticap^® XL 10
• Właściwości: hydrophobic
• producent / nazwa handlowa: Aervent^®
• Parametry: ≤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
• metody: gas filtration: suitable
• Długość: 13.2 in.
• Szerokość: 4.2 in.
• długość nominalna kartridża: 10 in. (25 cm)
• Średnica: 10.7 cm (4.2 in.)
• powierzchnia filtracyjna: 0.65 m²
• śr. przyłącza doprowadzającego: 3/4 in.
• szer. od złącza doprowadzającego do złącza odprowadzającego: 33.0 cm (13.0 in.)
• śr. przyłącza odprowadzającego: 3/4 in.
• zanieczyszczenia: <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤45 mg/cartridge
• macierz: Aervent^®
• wielkość porów: 0.2 μm pore size
• moc wejściowa: sample type gas
• punkt pęcherzykowania: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• dopasowywanie: 19 mm (3/4 in.) inlet/outlet sanitary flange

Opis

Opis ogólny

Device Configuration: Capsule

Opakowanie

Double Easy-Open bag

Jakość

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

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

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

Inne uwagi

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.

Informacje prawne

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

Oświadczenie o zrzeczeniu się odpowiedzialności

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.