- 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: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3.0 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。
技术参数
Specifications
物料 | polyethersulfone polyethylene support polypropylene (gamma-stable) polypropylene housing polypropylene vent cap (Gamma stable) 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 600 |
特点 | hydrophilic |
manufacturer/tradename | Millipore Express® |
参数 | ≤3.7 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 23 °C 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent) 6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent) 80 psi max. differential pressure (5.5 bar) (continuous) 80 psig max. inlet pressure |
technique(s) | sterile filtration: suitable |
长度 | 16.5 cm (6.5 in.) |
cartridge nominal length | 6.5 in. (16.5 cm) |
直径 | 5.6 cm (2.2 in.) |
过滤面积 | 590 cm2 |
inlet connection diam. | 3/4 in. |
inlet to outlet W | 16.5 cm (6.5 in.) |
outlet connection diam. | 3/4 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 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet) |
长度(mm) | |
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