SMP8A25NB6

OptiScale 25 Milligard PES 1.2/0.8 um NB

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

• 同義詞: Milligard^® PES 1.2/0.8 µm, OptiScale^® 囊式
• 分類程式碼代碼: 23151806

屬性

• 材料: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• 品質等級: 400
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible
• 產品線: OptiScale^® 25
• 特點: hydrophilic
• 製造商／商標名: OptiScale^®
• 參數: 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)
• 技術: prefiltration: suitable
• 長度: 3.9 cm (1.52 in.)
• 寬度: 1.21 in.
• 直徑: 3.1 cm (1.2 in.)
• 過濾面積: 3.5 cm²
• 雜質: <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)
• 基質: Milligard^® PES
• pore size: 1.2/0.8 μm pore size
• 接頭: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• 柱代碼: not applicable

描述

一般說明

Device Configuration: 取样皿滤膜

其他說明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

準備報告

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.

分析報告

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

法律資訊

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