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描述 产品目录编号 LAGR04TP6 商名 - Optiseal®
描述 Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic 产品信息 配置 Cartridge 最大压差[巴(psi)] Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C. Reverse: 4.1 (60) 滤芯代码 Double O-rings (2-123) with hold-down tabs 良好生产作业规范 These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 生物信息 细菌内毒素 按照 LAL 测试确定的≤0.5 EU/mL 媒质 Aervent® 灭菌 80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave cycles of 30 min @ 135 °C 细菌截留 Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. 可湿润性 疏水 理化信息 孔径(µm) 0.2 23°C时的泡点 ≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water 重量分析的提取物(%) The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature. HydroCorr ≤0.20 mL/min with water @ 2.6 bar (38 psig) 23°C时的氮扩散 ≤6 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water 非纤维释放 This product was manufactured with a PTFE membrane 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)] 4 (10) 过滤面积(m²) 0.18 装置尺寸(in) 4 材料信息 化学 - Polytetrafluoroethylene (PTFE)
装置材料 - Polypropylene
密封材料 Silicone 支撑材料 聚丙烯 包装信息 数量 6 包装 Double Easy-Open bag
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