MPVL10CA3

可γ辐照 Millipak -100 过滤单元 0.1 µm 9/16 in.HB/HB

filtration area 500 cm², matrix Durapore^®

• 别名: Millipak^®囊式过滤器，带Durapore^® 0.1 µm滤膜
• 分類程式碼代碼: 23151806

属性

• 材料: PVDF ; PVDF vent cap; polycarbonate ; polycarbonate support
• 品質等級: 400
• 無菌: irradiated; non-sterile
• 滅菌相容性: gamma compatible; gamma compatible
• 產品線: Millipak^®
• 特點: gamma compatible; hydrophilic
• 製造商／商標名: Millipak^®
• 參數: 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); 3.8 L/min flow rate at 2.45 bar (ΔP); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 50 L process volume
• 技術: sterile filtration: suitable
• 長度: 5.1 in.
• 寬度: 3.0 in.
• 直徑: 7.6 cm (3.0 in.)
• 過濾面積: 500 cm²
• 入口接頭直徑: 9/16 in.
• 出口接頭直徑: 9/16 in.
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤2.5 mg/device
• 基質: Durapore^®
• 孔徑: 0.1 μm
• 起泡點: ≥4830 mbar (70 psig), air with water at 23 °C
• 接頭: inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

说明

一般說明

Device Configuration: 取样皿滤膜

包裝

Double Easy-Open bag

其他說明

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

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.

準備報告

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).

分析報告

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

使用 ≥200 mL 水冲洗后，将符合“USP 氧化物检测”要求

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

法律資訊

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

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

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