产品介绍
Product Description
一般描述
设备配置：滤芯
包装
易开双层袋
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“无纤维脱落”过滤器标准的Durapore®滤膜制造。
分析说明
TOC/电导率 灭菌和5.5 L受控水冲洗后，按USP <64>检测，样品TOC小于500 ppb；按USP <64> （25 °C）检测，电导率小于1.3 µS/cm。
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 | ≤13.3 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) 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) 50 L/min flow rate at 1.4 bar (ΔP) |
| technique(s) | sterile filtration: suitable |
| 长度 | 10 in. |
| 宽度 | 2.7 in. |
| cartridge nominal length | 10 in. (25 cm) |
| 直径 | 6.9 cm (2.7 in.) |
| 过滤面积 | 0.69 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 | 0.22 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) |
