CLGL03TP3

Durapore^® 0.22 µm、High Area、カートリッジ

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 0

• UNSPSCコード: 23151806

特性

• 物質: PVDF membrane; polypropylene support; silicone O-ring
• 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^® II
• テクニック: sterile filtration: suitable
• L: 30 in.
• W: 2.7 in.
• カートリッジの長さ（公称）: 30 in. (75 cm)
• device size: 30 in.
• ろ過面積: 3.3 m²
• 不純物: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量分析抽出物: ≤30 mg/cartridge
• マトリックス: Durapore^® High Area
• ポアサイズ: 0.22 μm pore size
• コード: Code 0

詳細

詳細

Device configuration: Cartridge
Cartridge type: Liquid

調製ノート

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 ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature. 

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