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物料
PVDF
polypropylene
polypropylene support
silicone seal
质量水平
管理合规性
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)
无菌性
non-sterile
灭菌适用性
autoclavable compatible
steam-in-place compatible
产品线
Durapore®
特点
hydrophilic
制造商/商品名称
Durapore®
参数
≤60 mL/min air diffusion at 3.9 bar (56 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)
15 L/min flow rate at 230 mbar (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)
技术
sterile filtration: suitable
长度
30 in.
宽度
2.7 in.
纯化柱标称长度
30 in. (75 cm)
直径
6.9 cm (2.7 in.)
过滤面积
2.07 m2
杂质
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质
Durapore®
孔径
0.1 μm pore size
输入
sample type liquid
泡点
≥4830 mbar (70 psig), air with water at 23 °C
柱代码
Code 7 (2-226; O-rings w/locking-tabs)
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相关类别
一般描述
包装
其他说明
- 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 Durapore® Membrane 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
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
分析说明
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
After sterilization and a controlled water flush of 10.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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