MPGL06CB1

Millipak-60 灌装机过滤单元 0.22 µm 1/4 in. NPT-1/4 in.HB

sterile, filtration area 300 cm², matrix Durapore^®

• 别名: Millipak^®囊式过滤器，带Durapore^® 0.22 µm滤膜
• UNSPSC代码: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

属性

• 物料: PVDF membrane; PVDF vent cap; polycarbonate ; polycarbonate support
• 质量水平: 400
• 无菌性: irradiated; sterile
• 产品线: Millipak^®
• 特点: hydrophilic
• 制造商/商品名称: Millipak^®
• 参数: 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)
• 技术: sterile filtration: suitable
• 过滤面积: 300 cm²
• 入口接头直径: 1/4 in.
• 出口接头直径: 1/4 in.
• 杂质: ≤0.5 EU/mL (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量萃取物: ≤2 mg/device
• 基质: Durapore^®
• 孔径: 0.22 μm
• 泡点: ≥3450 mbar (50 psig), air with water at 23 °C
• 配件: NPT inlet connection; outlet hose barb; (6 mm (1/4 in.) NPTM Inlet and Outlet)
• 运输: ambient

说明

一般描述

Device Configuration: 取样皿滤膜

Number of stacked discs: 60 discs

包装

Double Easy-Open bag

其他说明

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.

制备说明

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).

分析说明

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

法律信息

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