KPGES006HH3

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

Opticap^® XL 600, sterile, inlet connection diam. 9/16 in., cartridge nominal length 6.5 in. (16.5 cm)

• 別名: Opticap XL 600 Millipore Express PHF Sterile 0.2 μm 9/16 in. HB/HB
• UNSPSCコード: 23151806

特性

• 物質: polyethersulfone ; polyethylene support; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; 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 600
• 特徴: hydrophilic
• メーカー／製品名: Millipore Express^®
• パラメーター: ≤5.8 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1000 bar max. differential pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 5500 mbar max. differential pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• テクニック: bioburden reduction: suitable
• L: 16.5 cm (6.5 in.)
• カートリッジの長さ（公称）: 6.5 in. (16.5 cm)
• 直径: 5.6 cm (2.2 in.)
• ろ過面積: 970 cm²
• 入口接続部直径: 9/16 in.
• 入口幅・出口幅: 16.5 cm (6.5 in.)
• 出口接続部直径: 9/16 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^® PHF
• ポアサイズ: 0.2 μm
• フィッティング: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

詳細

詳細

Device Configuration: カプセル

Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

包装

Double Easy-Open bag

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 of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

調製ノート

Sterilization Method
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).

アナリシスノート

次の水でフラッシング後USP Oxidizable Substances Testに適合 ≥1 L

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

TOC/Conductivity
After sterilization and a controlled water flush of 3.0 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。