产品名称
Opticap 可γ辐照 XL10 Durapore 0.22 µm 1-1/2 in.TC/TC, inlet connection diam. 1.5 in., Opticap® XL 10, cartridge nominal length 10 in. (25 cm)
material
PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
gamma compatible
product line
Opticap® XL 10
feature
gamma compatible
hydrophilic
manufacturer/tradename
Opticap®
parameter
≤14 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure
technique(s)
sterile filtration: suitable
L
33.5 cm (13.2 in.)
W
4.2 in.
cartridge nominal length
10 in. (25 cm)
diam.
10.7 cm (4.2 in.)
filtration area
0.73 m2
inlet connection diam.
1.5 in.
outlet connection diam.
1.5 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
≤25 mg/capsule
matrix
Durapore®
pore size
0.22 μm
input
sample type liquid
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
1/4 in. drain/vent hose barb (with double O-ring Seal)
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
Quality Level
Analysis Note
按ASTM® F838方法进行细菌挑战,样品可截留1 x 10⁷ CFU/cm²以上浓度的缺陷短波单孢菌。
Disclaimer
General description
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。
Packaging
Preparation Note
在126 °C下进行 90 分钟的 3 个高压灭菌循环;可耐受45千戈瑞(4.5兆拉德)伽马射线照射;不能连续蒸汽灭菌
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