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.)

• UNSPSCコード: 23151806

特性

• 物質: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene prefilter; silicone seal
• 品質水準: 400
• 法規制遵守: meets FDA 21 CFR 177-182 (all component materials)
• 無菌性: non-sterile
• 滅菌適合性: autoclavable compatible; steam-in-place compatible
• 製品種目: Polysep^™
• 特徴: hydrophilic
• メーカー／製品名: Polysep^™
• パラメーター: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• テクニック: prefiltration: suitable
• L: 40 in.
• W: 2.7 in.
• カートリッジの長さ（公称）: 100 cm (40 in.)
• フィルタ直径: 7.1 cm (2.8 in.)
• filter filtration area: 1.68 m²
• 不純物: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction ); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction )
• マトリックス: Polysep^™ II
• pore size: 1.0/0.2/0.1 μm nominal pore size; 1.0/0.2/0.1 μm pore size
• カートリッジコード: Code 0

詳細

詳細

Device Configuration: Cartridge

特徴および利点

Triple Layer

包装

Double Easy-Open bag

調製ノート

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

アナリシスノート

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

その他情報

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.

法的情報

Polysep is a trademark of Sigma-Aldrich Co. LLC