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Multilayer Durapore^® 0.45/0.22 µm、オプティキャップ（Opticap）^® XLTカプセル

sterile, Opticap^® XLT 30, inlet connection diam. 1.5 in., pore size 0.45/0.22 μm, cartridge nominal length 30 in. (75 cm)

• 別名: Opticap Sterile Multilayer XLT30 Durapore 0.45/0.22 m 1-1/2 in. TC
• UNSPSCコード: 23151806

特性

• 物質: PVDF ; polyester support; polyethylene support; polypropylene ; polypropylene housing; polypropylene vent cap; silicone seal
• 品質水準: 400
• 法規制遵守: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 無菌性: irradiated; sterile
• 製品種目: Opticap^® XLT 30
• 特徴: hydrophilic
• メーカー／製品名: Opticap^®
• パラメーター: ≤45.0 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1.05 bar max. differential pressure (15 psid) at 80 °C (Forward); 2.75 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
• テクニック: sterile filtration: suitable
• L: 87.1 cm (34.3 in.)
• カートリッジの長さ（公称）: 30 in. (75 cm)
• 直径: 10.7 cm (4.2 in.)
• ろ過面積: 1.81 m²
• 入口接続部直径: 1.5 in.
• 入口幅・出口幅: 15.2 cm (6.0 in.)
• 出口接続部直径: 1.5 in.
• 不純物: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• マトリックス: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• 入力: sample type liquid
• 泡立ち点: ≥3450 mbar (50 psig), air with water at 23 °C
• フィッティング: 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)

詳細

詳細

Device Configuration: カプセル

T-line/Gauge Port: T-line

包装

ダブル イージーオープン バッグ

その他情報

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

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.

調製ノート

Sterilization Method
126 °C 60分のオートクレーブ滅菌3回；インライン蒸気滅菌不可

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).

アナリシスノート

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

次の水でフラッシング後USP Oxidizable Substances Testに適合 ≥4.5 L

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

法的情報

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