MFGL10SL3

Durapore^® 0.22 µm, Millipak^® Final Fill灌装囊式过滤器

Millipak^® Final Fill 100, sterile; γ-irradiated

• 分類程式碼代碼: 23151806

属性

• 材料: polysulfone device; polysulfone support
• 品質等級: 400
• agency: meets EP 2.6.14; meets JP 4.01; meets USP 85
• 無菌: irradiated; sterile; γ-irradiated
• 產品線: Millipak^® Final Fill 100
• 特點: hydrophilic
• 製造商／商標名: Millipak^®
• 參數: 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 100 L process volume; 3.81 L/min flow rate at 1.1 bar (ΔP); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• 技術: sterile filtration: suitable
• 過濾器過濾面積: 500 cm²
• 雜質: <0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
• 基質: Durapore^®
• 孔徑: 0.22 μm pore size
• 起泡點: ≥50 psi (3450 mbar), air with water
• 接頭: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb Outlet)

说明

一般說明

Device Configuration: Gamma Gold Capsule

包裝

Double Easy-Open bag

準備報告

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

分析報告

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

其他說明

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 general guidelines section of user guide shipped with this product
• Storage Statement: Please refer user guide shipped with this product
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

法律資訊

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

ATCC is a registered trademark of American Type Culture Collection

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

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