- 商品介绍
- 规格参数
- 包装参数
产品介绍
Product Description
一般描述
设备配置:纯化柱
包装
双易开袋
其他说明
这些产品在符合FDA药品生产质量管理规范的工厂生产。
制备说明
本产品采用符合21 CFR 210.3(b)(6)中规定的“无纤维释放”过滤器标准的Durapore®膜制造。
分析说明
用水冲洗 ≥500 mL 后,将满足 USP 可氧化物质测试要求
技术参数
Specifications
物料 | PVDF polypropylene polypropylene support silicone seal |
质量水平 | 400 |
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) |
无菌性 | non-sterile |
sterilization compatibility | autoclavable compatible steam-in-place compatible |
产品线 | Durapore® EMPROVE® Filter |
特点 | hydrophilic |
manufacturer/tradename | Durapore® |
参数 | ≤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 |
长度 | 5 in. |
宽度 | 2.7 in. |
cartridge nominal length | 5 in. (12.5 cm) |
直径 | 6.9 cm (2.7 in.) |
过滤面积 | 0.35 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) |
gravimetric extractables | ≤10 mg/cartridge |
基质 | Durapore® |
孔径 | 0.22 μm pore size |
input | sample type liquid |
泡点 | ≥3450 mbar (50 psig), air with water at 23 °C |
柱代码 | Code 7 (2-226; O-rings w/locking-tabs) |
长度(mm) | |
宽度(mm) | |
高度(mm) | |
重量(kg) |
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