KHVES05TT1

ミリポアエクスプレス（Millipore Express）^®SHRP、オプティキャップ（Opticap）^®XLカプセル

sterile, Opticap^® XL 5, inlet connection diam. 1.5 in., pore size 0.5/0.1 μm, cartridge nominal length 5 in. (12.5 cm)

• 別名: Opticap Sterile XL 5 Millipore Express SHR with prefilter 0.5/0.1 μm 1-1/2 in. TC/TC
• UNSPSCコード: 23151806

特性

• 物質: polyester support; polyethersulfone ; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap (Gamma stable); polysulfone ; 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^® XL 5
• 特徴: hydrophilic
• メーカー／製品名: Millipore Express^®
• パラメーター: ≤13.6 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 100 psi max. differential pressure (6.9 bar) (intermittent); 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• テクニック: sterile filtration: suitable
• L: 21.6 cm (8.5 in.)
• カートリッジの長さ（公称）: 5 in. (12.5 cm)
• 直径: 14.5 cm (5.7 in.)
• ろ過面積: 0.24 m²
• 入口接続部直径: 1.5 in.
• 入口幅・出口幅: 21.6 cm (8.5 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: Millipore Express^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• 泡立ち点: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/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

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 installation section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules 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
123 °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 Millipore Express^® 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 ≥2 L

TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

法的情報

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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

免責事項

EMD Millipore Corporationは本製品が欧州の圧力機器指令97/23/EC (1997年5月29日施行) に適合していることを証明します。本製品は圧力容器指令第3条3項に基づき分類されています。使用時の安全性を保証するため、適切なエンジニアリング方式に沿って設計・製造されています。本製品は圧力容器指令第3条3項に従い、CEマークは表示されていません。