半岛bd体育手机客户端 说明
一般描述
Device Configuration: 取样皿滤膜
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
包装
Double Easy-Open bag
其他说明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
制备说明
This product was manufactured with a Millipore Express?membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
分析说明
Bacterial Retention
Samples of membrane used in this filter were quantitatively retentive of a minimumBrevundimonas diminutachallenge concentration of 1 x 10? CFU/cm? using ASTM?F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 6.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 ?S/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
免责声明
EMD Millipore Corporation
半岛bd体育手机客户端 性质
质量水平 | 400 |
物料 | polyester support polyethersulfone polypropylene (gamma-stable) polypropylene housing polypropylene vent cap polysulfone silicone seal |
reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
无菌性 | sterile |
特点 | hydrophilic |
manufacturer/tradename | Millipore Express? |
参数 | ≤17.4 mL/min air diffusion at 2.8 bar (40 psig) and 23 ℃ (in water) 1.0 bar max. inlet pressure (15 psi) at 80 ℃ 1000 bar max. differential pressure (15 psi) at 80 ℃ 2.75 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 5.5 bar max. inlet pressure (80 psi) at 25 ℃ 5500 mbar max. differential pressure (80 psi) at 25 ℃ 80 psig max. inlet pressure |
长度 | 21.6 cm (8.5 in.) |
cartridge nominal length | 5 in. (12.5 cm) |
直径 | 10.7 cm (4.2 in.) |
过滤面积 | 0.31 m2 |
inlet connection diam. | 1.5 in. |
inlet to outlet W | 21.6 cm (8.5 in.) |
outlet connection diam. | 1.5 in. |
总尺寸 | 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?PHF |
孔径 | 0.2 μm nominal pore size 0.2 μm pore size |
配件 |
inlet sanitary flange 38 mm (1 outlet sanitary flange |
Sigma-Aldrich