产品说明
一般描述
Device Configuration: Cartridge
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
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C and 0.35 bar (5) or 3 forward SIP cycles of 30 min @ 135 °C and 1 bar (15 psid); 25 autoclave cycles of 60 min @ 126 °C
分析说明
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
基本信息
eCl@ss | 32031690 |
产品性质
质量水平 | 400 |
物料 | polyethersulfone polypropylene polypropylene support polysulfone silicone seal |
reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
无菌性 | sterile |
产品线 | EMPROVE® Filter |
特点 | hydrophilic |
manufacturer/tradename | Millipore Express® |
参数 | ≤13.3 mL/min air diffusion at 2.8 bar (40 psig) and 23 ℃ (in water) 0.07 bar max. inlet pressure (1 psi) at 135 ℃ (Reverse) 1.0 bar max. inlet pressure (15 psi) at 135 ℃ (Forward) 1.7 bar max. inlet pressure (25 psi) at 80 ℃ (Forward) 1700 bar max. differential pressure (25 psi) at 80 ℃ (Forward) 2.07 bar max. inlet pressure (30 psi) at 25 ℃ (Reverse) 2100 mbar max. differential pressure (30 psi) at 25 ℃ (Reverse) 340 mbar max. differential pressure (5 psi) at 135 ℃ (Forward) 69 mbar max. differential pressure (1 psi) at 135 ℃ (Reverse) 6900 mbar max. differential pressure (100 psi) at 25 ℃ (Forward) 7 bar max. inlet pressure (100 psi) at 25 ℃ (Forward) |
cartridge nominal length | 5 in. (12.5 cm) |
直径 | 6.9 cm (2.7 in.) |
过滤面积 | 0.23 m2 |
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® SHC |
pore size | 0.5/0.2 μm pore size |
input | sample type liquid |
bubble point | ≥4000 mbar (58 psig), air with water at 23 ℃ |
cartridge code | Code 7 |
Sigma-Aldrich