CV0302TP3

Multimedia Durapore^® 0.2/0.22 µm, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 0

• UNSPSCコード: 23151806

特性

• 物質: mixed cellulose esters (MCE) prefilter; polypropylene device; polypropylene support; 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: Durapore^®
• 特徴: hydrophilic
• メーカー／製品名: Durapore^®
• パラメーター: ≤26.6 mL/min air diffusion at 2.75 bar (40 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (reverse; intermittent); 3.5 bar max. inlet temp. (50 psi) at 25 °C (reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (forward)
• テクニック: prefiltration: suitable
• L: 20 in.
• W: 2.7 in.
• カートリッジの長さ（公称）: 20 in. (50 cm)
• device size: 20 in.
• フィルタ直径: 2.7 in. (6.9 cm)
• filter filtration area: 1.38 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)
• 重量分析抽出物: ≤45 mg/cartridge
• マトリックス: Multimedia Durapore^®
• pore size: 0.2/0.22 μm pore size
• 泡立ち点: ≥3450 mbar (50 psig), air with water
• コード: Code 0

詳細

詳細

Device configuration: Cartridge
Cartridge type: Liquid

包装

Double Easy-Open bag

調製ノート

Sterilization Method: 6 autoclave or SIP cycles of 30 min at 123°C

This product was manufactured with a Durapore^®  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

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm²  using ASTM^® F838 methodology.

Gravimetric Extractables: The extractables level was ≤ 45 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 ≥ 10 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 to Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法的情報

ASTM is a registered trademark of American Society for Testing and Materials

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