属性
物料
PVDF membrane
PVDF vent cap
polycarbonate
polycarbonate support
质量水平
400
无菌性
sterile
产品线
EMPROVEFilter
特点
hydrophilic
manufacturer/tradename
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)
25 °C max. temp.
3.8 L/min flow rate at 1.75 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
过滤面积
300cm2
inlet connection diam.
1/4in.
outlet connection diam.
1/4in.
杂质
≤0.5EU/mL (LAL test, Aqueous extraction)
<0.5EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤2mg/device
基质
Durapore
孔径
0.22μm nominal pore size
0.22μm pore size
bubble point
≥3450mbar (50psig), air with water at 23°C
配件
inlet hose barb
6 mm (1/4 in.) inlet/outlet hose barb (with bell)
outlet hose barb (with bell)
运输
ambient
说明
一般描述
Device Configuration: Gamma Gold Capsule
包装
水泡眼包装
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 DuraporeMembrane 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
123 °C 时 90 分钟的 3 个高压高温周期；不进行在线蒸汽消毒
This product was manufactured with a Duraporemembrane 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 minimumBrevundimonas diminutachallenge concentration of 1 x 10 CFU/cm2 using ASTMF838 methodology.
使用 ≥200 mL 水冲洗后，将符合“USP 氧化物检测”要求
Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature