屬性
物料
PVDF membrane
PVDF vent cap
polycarbonate
polycarbonate support
質(zhì)量水平
400
無(wú)菌性
sterile
產(chǎn)品線
EMPROVEFilter
特點(diǎn)
hydrophilic
manufacturer/tradename
Millipak
參數(shù)
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
過(guò)濾面積
300cm2
inlet connection diam.
1/4in.
outlet connection diam.
1/4in.
雜質(zhì)
≤0.5EU/mL (LAL test, Aqueous extraction)
<0.5EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤2mg/device
基質(zhì)
Durapore
孔徑
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)
運(yùn)輸
ambient
說(shuō)明
一般描述
Device Configuration: Gamma Gold Capsule
包裝
水泡眼包裝
其他說(shuō)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.
制備說(shuō)明
Sterilization Method
123 °C 時(shí) 90 分鐘的 3 個(gè)高壓高溫周期；不進(jìn)行在線蒸汽消毒
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).
分析說(shuō)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 水沖洗后，將符合“USP 氧化物檢測(cè)”要求
Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature