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描述 产品目录编号 CGW6F1E03 商名 - Polysep®
描述 Polysep® II Cartridge Filter 10 in. 0.5 µm Code F 产品信息 格式 Double Layer 配置 Cartridge 最大压差[巴(psi)] 3.5 (50) @ 25 °C 滤芯代码 Code F double open end w/flat gaskets 良好生产作业规范 These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 预过滤器材料 Borosilicate Glass Fiber (BGF) 生物信息 细菌内毒素 按照 LAL 测试确定的≤0.5 EU/mL 媒质 Polysep™ II 消毒 30 min with hot water @ 80 °C 灭菌 10 autoclave cycles or SIP @ 121 °C for 30 min 理化信息 重量分析的提取物(%) The extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. 间接食品添加剂 All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food. 非纤维释放 This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). 尺寸 滤芯标称长度 [in (cm)] 10 (25) 直径 [cm (in)] 7.1 (2.8) 过滤面积(m²) 0.46 装置尺寸(in) 10 标称孔径(µm) 1.0 / 0.5 材料信息 化学 - Mixed Cellulose Esters (MCE)
装置材料 - Polypropylene
密封材料 Ethylene Propylene 支撑材料 Spun bonded polypropylene 包装信息 数量 3 包装 Double Easy-Open bag 规格 可氧化物质 Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
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