KVVLG10HH1

Durapore^® 0.1 µm, Opticap^® XL Capsule

Opticap^® XL 10, inlet connection diam. 9/16 in., cartridge nominal length 10 in. (25 cm)

• Synonim(y): Opticap Gamma Compatible Sterilizing Grade XL10 Durapore 0.1 μm Gamma Compatible 9/16 in. HB/HB
• Kod UNSPSC: 23151806

Właściwości

• Materiały: PVDF ; polyester support; polyethylene support; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; silicone outer O-ring; silicone-coated EPDM rubber lead O-ring
• Poziom jakości: 400
• zgodność regionalna: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterylność: irradiated; non-sterile
• Kompatybilność ze sterylizacją: gamma compatible
• linia produktu: Opticap^® XL 10
• Właściwości: gamma compatible; hydrophilic
• producent / nazwa handlowa: Opticap^®
• Parametry: ≤21.1 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 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
• metody: sterile filtration: suitable
• Długość: 33.5 cm (13.2 in.)
• Szerokość: 4.2 in.
• długość nominalna kartridża: 10 in. (25 cm)
• Średnica: 10.7 cm (4.2 in.)
• powierzchnia filtracyjna: 0.73 m²
• śr. przyłącza doprowadzającego: 9/16 in.
• szer. od złącza doprowadzającego do złącza odprowadzającego: 33.5 cm (13.2 in.)
• śr. przyłącza odprowadzającego: 9/16 in.
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤25 mg/capsule
• macierz: Durapore^®
• wielkość porów: 0.1 μm
• moc wejściowa: sample type liquid
• punkt pęcherzykowania: ≥4830 mbar (70 psig), air with water at 23 °C
• dopasowywanie: 1/4 in. drain/vent hose barb (with double O-ring Seal); (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

Opis

Opis ogólny

Device Configuration: Capsule

Opakowanie

Double Easy-Open bag

Inne uwagi

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Powiązanie

Replaces: KVVL01HB1

Uwaga dotycząca przygotowania

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable

This product was manufactured with a Durapore^® 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 water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Informacje prawne

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

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, 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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