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
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer wetting instructions of Filters with MILLIPORE EXPRESS® Membrane user guide
- Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
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; 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 ≥1 L
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 5.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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 | EPDM rubber seal polyethersulfone polypropylene polypropylene support polysulfone |
| reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
| 产品线 | EMPROVE® Filter |
| 特点 | hydrophilic |
| manufacturer/tradename | Millipore Express® |
| 参数 | ≤16.4 mL/min air diffusion at 2.75 bar (40 psig) and 23 ℃ (in water) 0.07 bar max. inlet pressure (1 psi) at 135 ℃ (Reverse) 0.35 bar max. inlet pressure (5 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 | 0.29 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® SHF |
| 孔径 | 0.2 μm nominal pore size 0.2 μm pore size |
| input | sample type liquid |
| bubble point | ≥4000 mbar (58 psig), air with water at 23 ℃ |
| cartridge code | Code 7 |
