产品名称
Optiseal Durapore 筒式过滤器 0.45 µm 带预滤器, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 4 in.
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
OptiSeal® 4 in.
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤15 mg/cartridge
matrix
Durapore® (w/Prefilter)
pore size
0.45 μm
input
sample type liquid
bubble point
≥1930 mbar (28 psig), air with water at 23 °C
cartridge code
not applicable
material
PVDF , mixed cellulose esters (MCE) prefilter, polypropylene , polypropylene support, silicone seal
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
feature
hydrophilic
manufacturer/tradename
OptiSeal®
parameter
≤4 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water), 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward), 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse), 3.5 bar max. differential pressure (50 psid) at 80 °C (Forward), 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse), 3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
technique(s)
bioburden reduction: suitable
L
4 in.
cartridge nominal length
4 in. (10 cm)
filtration area
0.18 m2
Quality Level
General description
Packaging
Preparation Note
10个高压灭菌循环或SIP @ 121 °C,持续30分钟
Analysis Note
Other Notes
- 生物截留:微生物
- 作用机制:过滤(体积排阻)
- 应用:生物处理
- 预期用途:减少或去除微生物/生物负荷
- 使用说明:参见《Durapore® 滤膜过滤器润湿说明》用户手册
- 存储声明:干燥储存
- 处置声明:根据国家、省市和当地适用法规处置。
Legal Information
存储类别
4.1B - Flammable solid hazardous materials
wgk
WGK 3
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