重要规格表
| 描述
|
| 产品目录编号 | MPHL04GH2 |
| 商名 | |
| 描述 | Millipak 40 过滤器 0.45 µm 1/4 in. HB/HB w/无菌钟罩 |
| 产品信息
|
| Device Configuration | Gamma Gold Capsule |
| 连接（入口/出口） | 6 mm (1/4 in.) 带钟罩的倒刺软管接口 |
| 最大压差[巴（psi）] | Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C |
| 最大入口压力[巴（psi）] | 5.2 bar (75 psi) @ 25 °C |
| 良好生产作业规范 | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Quality Level | MQ400
|
| 生物信息
|
| 细菌内毒素 | 按照 LAL 测试确定的≤0.5 EU/mL |
| 媒质 | Durapore® |
| 无菌性 | 无菌 |
| 灭菌 | 123 °C 时 90 分钟的 3 个高压高温周期；不可进行在线蒸汽消毒 |
| 可湿润性 | 亲水性 |
| 理化信息
|
| 孔径 | 0.45 µm |
| 入口连接 | Hose Barb |
| 出口连接 | Hose Barb with Bell |
| 23°C时的泡点 | ≥1790 mbar (26 psig) 空气中含水 |
| 流量 | 8.5 L/min @ 2.45 bar ΔP |
| 重量分析的提取物（%） | The extractables level was equal to or less than 1.5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature. |
| 非纤维释放 | This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). |
| USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| 尺寸
|
| 过滤面积 | 200 cm² |
| 工艺体积 | 20 L |
| 入口连接直径 | 1/4 in. |
| 出口连接直径 | 1/4 in. |
| 材料信息
|
| 化学 | - Polyvinylidene Fluoride (PVDF)
|
| 装置材料 | |
| 支撑材料 | 聚碳酸酯 |
| 通风盖材料 | PVDF |
| 规格
|
| 可氧化物质 | 使用 ≥200 mL 水冲洗后，将符合“USP 氧化物检测”要求 |
