产品名称
Durapore® 0.22 µm,小柱, pore size 0.22 μm, cartridge nominal length 5 in. (12.5 cm), Code 7 (2-226; O-rings w/locking-tabs)
material
PVDF
polypropylene
polypropylene support
silicone seal
reg. compliance
meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food)
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Durapore®
EMPROVE® Filter
feature
hydrophilic
manufacturer/tradename
Durapore®
parameter
≤6.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
25 L/min flow rate at 1.4 bar (ΔP)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse)
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)
sterile filtration: suitable
L
5 in.
W
2.7 in.
cartridge nominal length
5 in. (12.5 cm)
diam.
6.9 cm (2.7 in.)
filtration area
0.35 m2
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
≤10 mg/cartridge
matrix
Durapore®
pore size
0.22 μm pore size
input
sample type liquid
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
cartridge code
Code 7 (2-226; O-rings w/locking-tabs)
Quality Level
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Analysis Note
使用ASTM® F838方法,对样品进行最小保留的缺陷短波单孢菌挑战浓度为 1 × 10⁷ CFU/cm² 的定量保留。
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:请参阅《Durapore®薄膜用户指南》中的过滤器单元润湿说明
- 储存条件: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
30个SIP循环,30 min @ 135 °C; 30个高压灭菌循环,60 min @ 126 °C
Legal Information
商品
Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).
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