KEGBG003FF3

ミリポアエクスプレス（Millipore Express）^®SPG 0.2 µm、オプティキャップ（Opticap）^®XLカプセル

Opticap^® XL 300, inlet connection diam. 3/4 in., pore size 0.2 μm

• 別名: Gamma Phobic Opticap^® XL 300 Express SPG 0.2 sanitary flange
• UNSPSCコード: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

特性

• 物質: polyethersulfone membrane; polyethylene support; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• 品質水準: 400
• 無菌性: irradiated; non-sterile
• 滅菌適合性: gamma compatible
• 製品種目: Opticap^® XL 300
• 特徴: hydrophobic
• メーカー／製品名: Opticap^®
• パラメーター: 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 25 °C max. inlet temp.; 4.1 bar max. inlet pressure (60 psi) at 23 °C; 4.2 bar max. differential pressure (60 psid) at 25 °C (Forward); 60 psi max. differential pressure (4.1 bar) (continuous); 60 psig max. inlet pressure
• テクニック: gas filtration: suitable
• L: 11.9 cm (4.7 in.)
• 直径: 5.6 cm (2.2 in.)
• ろ過面積: 0.048 m²
• 入口接続部直径: 3/4 in.
• 入口幅・出口幅: 11.9 cm (4.7 in.)
• 出口接続部直径: 3/4 in.
• 不純物: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量分析抽出物: ≤3 mg
• マトリックス: Millipore Express^® SPG
• ポアサイズ: 0.2 μm pore size
• 泡立ち点: ≥1210 mbar (17.5 psig), air 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; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
• 輸送温度: ambient

詳細

詳細

Device Configuration: カプセル

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 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
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).

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.

HydroCorr: ≤0.16 mL/min @ 2.6 bar (38 psig)

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

TOC/Conductivity
After gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.

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

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。