MPGL06CF3

Durapore^® 0.22 µm、Millipak^®カプセル

sterile, filtration area 300 cm², matrix Durapore^®

• 別名: Millipak-60 Filling Machine Filter Unit 0.22 μm 3/4 in. TC/TC
• UNSPSCコード: 23151806

特性

• 物質: PVDF ; PVDF vent cap; polycarbonate ; polycarbonate support
• 品質水準: 400
• 無菌性: irradiated; sterile
• 製品種目: EMPROVE^® Filter
• 特徴: hydrophilic
• メーカー／製品名: Millipak^®
• パラメーター: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 30 L process volume; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 7.6 L/min flow rate at 2.9 bar (ΔP)
• テクニック: sterile filtration: suitable
• ろ過面積: 300 cm²
• 入口接続部直径: 3/4 in.
• 出口接続部直径: 3/4 in.
• 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: ≤2 mg/device
• マトリックス: Durapore^®
• ポアサイズ: 0.22 μm
• 泡立ち点: ≥3450 mbar (50 psig), air with water at 23 °C
• フィッティング: inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

詳細

詳細

Device Configuration: カプセル

Number of stacked discs: 60 discs

包装

Double Easy-Open bag

その他情報

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

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 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.

調製ノート

Sterilization Method
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable

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.

次の水でフラッシング後USP Oxidizable Substances Testに適合 ≥200 mL

Gravimetric Extractables: after 24 hours in water at controlled room temperature

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

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

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