SMP8A25NB6

Milligard^® PES 1.2/0.8 µm, OptiScale^® Capsule

filtration area 3.5 cm², OptiScale^® 25, pore size 1.2/0.8 μm

• 別名: OptiScale 25 Milligard PES 1.2/0.8 μm NB
• UNSPSCコード: 23151806

特性

• 物質: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• 品質水準: 400
• 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: OptiScale^®
• パラメーター: 0 bar max. differential pressure (Reverse); 4.14 bar max. differential pressure (60 psi) at 25 °C (Forward); 60 psi max. inlet pressure (4.1 bar)
• テクニック: prefiltration: suitable
• L: 3.9 cm (1.52 in.)
• W: 1.21 in.
• 直径: 3.1 cm (1.2 in.)
• ろ過面積: 3.5 cm²
• 不純物: <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
• マトリックス: Milligard^® PES
• pore size: 1.2/0.8 μm pore size
• 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)
• カートリッジコード: not applicable

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: Bacterial
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

調製ノート

Devices tested and meet requirements of USP <78> for large volume parenterals.

Sterilization Method
Capsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.

アナリシスノート

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

法的情報

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

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

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