SPGEA25NB6

Millipore Express^® PHF, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm²

• 別名: Millipore Express PHF Optiscale 25mm 0.2 m NB
• UNSPSCコード: 23151806
• eCl@ss: 32031690

特性

• 物質: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• 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: non-sterile
• 滅菌適合性: autoclavable compatible
• 製品種目: OptiScale^® 25
• 特徴: hydrophilic
• メーカー／製品名: Millipore Express^®
• パラメーター: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• テクニック: bioburden reduction: suitable
• L: 3.9 cm (1.52 in.)
• W: 1.21 in.
• カートリッジの長さ（公称）: 1.52 in. (39 mm)
• 直径: 3.1 cm (1.2 in.)
• ろ過面積: 3.5 cm²
• 不純物: ≤0.25 EU/mL (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: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• 輸送温度: ambient

詳細

詳細

Device Configuration: カプセル

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
1 autoclave cycle of 60 min @ 123 °C

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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

法的情報

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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

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

安全性情報

• 保管分類コード: 11 - Combustible Solids