CGW104S03

Polysep^™ II 1.0/0.2/0.1 µm nominal, Cartridge

pore size 1.0/0.2/0.1 μm, cartridge nominal length 100 cm (40 in.), filter diam. 7.1 cm (2.8 in.)

• 分類程式碼代碼: 23151806

属性

• 材料: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene prefilter; silicone seal
• 品質等級: 400
• 法律遵循: meets FDA 21 CFR 177-182 (all component materials)
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible; steam-in-place compatible
• 產品線: Polysep^™
• 特點: hydrophilic
• 製造商／商標名: Polysep^™
• 參數: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• 技術: prefiltration: suitable
• 長度: 40 in.
• 寬度: 2.7 in.
• 柱標稱長度: 100 cm (40 in.)
• 過濾器直徑: 7.1 cm (2.8 in.)
• 過濾器過濾面積: 1.68 m²
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction ); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction )
• 基質: Polysep^™ II
• pore size: 1.0/0.2/0.1 μm nominal pore size; 1.0/0.2/0.1 μm pore size
• 柱代碼: Code 0

说明

一般說明

Device Configuration: Cartridge

特點和優勢

Triple Layer

包裝

Double Easy-Open bag

準備報告

Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C

分析報告

Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 20 L

其他說明

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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
• Storage Statement: Please refer Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

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

法律資訊

Polysep is a trademark of Sigma-Aldrich Co. LLC