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Millipore Express^® SHC High Area, Opticap^® XLT Capsule

Opticap^® XLT 10, non-sterile, pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)

• Synonim(y): Gamma Compatible High Area Opticap^® XLT 10 Millipore Express^® SHC 0.5 µm/ 0.2 µm 1-1/2 in. TC-1 in. HB
• Kod UNSPSC: 23151806

Właściwości

• Materiały: polyester support; polyethersulfone ; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Poziom jakości: 400
• zgodność regionalna: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: gamma compatible
• linia produktu: Opticap^® XLT 10
• Właściwości: hydrophilic
• producent / nazwa handlowa: Millipore Express^®
• Parametry: ≤56.4 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1.0 bar max. differential pressure (15 psi) at 80 °C (Forward); 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent); 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psi) at 25 °C (Forward); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent); 80 psig max. inlet pressure
• metody: sterile filtration: suitable
• Długość: 37.6 cm (14.8 in.)
• Szerokość: 4.2 in.
• długość nominalna kartridża: 10 in. (25 cm)
• Średnica: 10.7 in. (4.2 cm)
• powierzchnia filtracyjna: 1.0 m²
• szer. od złącza doprowadzającego do złącza odprowadzającego: 17.5 cm (6.9 in.)
• śr. przyłącza odprowadzającego: 1 in.
• zanieczyszczenia: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
• macierz: Millipore Express^® SHC High Area
• pore size: 0.5/0.2 μm pore size
• punkt pęcherzykowania: ≥4000 mbar (58 psig), air with water at 23 °C
• dopasowywanie: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet sanitary flange; outlet hose barb; (38 mm (1 1/2 in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)
• Zastosowanie: sample preparation

Opis

Opis ogólny

T-line/Gauge Port: T-line

Opakowanie

Double Easy-Open bag

Inne uwagi

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

Uwaga dotycząca przygotowania

Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable

This product was manufactured with a Millipore Express^® 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
Quantitative retention of 10⁷ CFU/cm²Brevundimonas diminuta (ATCC^® 19146) per HIMA methodology

TOC/Conductivity
After sterilization and a controlled water flush of 21 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Informacje prawne

ATCC is a registered trademark of American Type Culture Collection

MILLIPORE EXPRESS 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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