- 商品介绍
- 规格参数
- 包装参数
一般描述
设备配置：胶囊
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5.0 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>）。
免责声明
EMD Millipore Corporation保证，本品符合欧盟承压设备指令(European Pressure Equipment Directive, 97/23/EC of 29 May 1997)要求。本品依照欧盟承压设备指令Article 3 § 3条款要求分类。根据安全工程规范(sound engineering practice)设计和生产，确保安全使用。根据承压设备指令Article 3 § 3条款要求，本品不带CE标志。
| 物料 | polyester support polyethersulfone polypropylene polypropylene housing polypropylene vent cap 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 | irradiated sterile |
| 产品线 | Opticap® XL 3 |
| 特点 | hydrophilic |
| manufacturer/tradename | Millipore Express® |
| 参数 | ≤7.6 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water) 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward) 1.0 bar max. inlet pressure (15 psi) at 80 °C 100 psi max. differential pressure (6.9 bar) (intermittent) 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent) 2.75 bar max. inlet pressure (40 psi) at 60 °C 25 °C max. inlet temp. 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward) 5.5 bar max. inlet pressure (80 psi) at 25 °C 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent) 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent) 80 psi max. differential pressure (5.5 bar) (continuous) 80 psig max. inlet pressure |
| technique(s) | sterile filtration: suitable |
| 长度 | 17.3 cm (6.8 in.) |
| cartridge nominal length | 3 in. (7.5 cm) |
| 直径 | 10.7 cm (4.2 in.) |
| 过滤面积 | 0.13 m2 |
| inlet connection diam. | 1.5 in. |
| inlet to outlet W | 17.3 cm (6.8 in.) |
| outlet connection diam. | 1.5 in. |
| 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® SHC |
| pore size | 0.5/0.2 μm pore size |
| 泡点 | ≥4000 mbar (58 psig), air with water at 23 °C |
| 配件 | 1/4 in. drain/vent hose barb (with double O-ring seal) inlet sanitary flange outlet sanitary flange (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet) |
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