产品介绍
Product Description
一般描述
设备配置：纯化柱
包装
双层易开袋
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Millipore Express®膜制造。
分析说明
TOC/电导率 在灭菌和5.5 L的受控水冲洗后，样品在25 °C下显示出低于500 ppb TOC（根据USP<64>）和低于1.3 µS/cm（根据USP<64>）。
技术参数
Specifications
| 物料 | polyethersulfone polypropylene polypropylene support polysulfone silicone seal |
| 质量水平 | 400 |
| reg. compliance | 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 | EMPROVE® Filter Millipore Express® |
| 特点 | hydrophilic |
| manufacturer/tradename | Millipore Express® |
| 参数 | ≤16.4 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water) 0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse) 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward) 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward) 1700 bar max. differential pressure (25 psi) at 80 °C (Forward) 2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse) 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse) 340 mbar max. differential pressure (5 psi) at 135 °C (Forward) 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse) 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward) 7 bar max. inlet pressure (100 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 | 0.29 m2 |
| 杂质 | ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| 基质 | Millipore Express® SHF |
| 孔径 | 0.2 μm pore size |
| input | sample type liquid |
| 泡点 | ≥4000 mbar (58 psig), air with water at 23 °C |
| 柱代码 | Code 7 |
