产品说明
一般描述
Device Configuration: 取样皿滤膜
其他说明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Bacterial
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation and wetting sections of OPTISCALE®-25 user guide
- Storage Statement: Please refer OPTISCALE®-25 user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
制备说明
Sterilization Method
1 autoclave cycle of 60 min @ 123 °C
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析说明
TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
This product was tested and passes the USP <78> test for particulates in injectables.
法律信息
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
OPTISCALE is a registered trademark of Merck KGaA, Darmstadt, Germany
基本信息
| eCl@ss | 32031610 |
| NACRES | NB.24 |
产品性质
| 物料 | PVDF membrane polypropylene polypropylene support polypropylene vent cap |
| 质量水平 | 400 |
| 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 | OptiScale® |
| 参数 | 4.1 bar max. inlet pressure (60 psi) at 25 ℃ 60 psi max. differential pressure (4.1 bar) at 25 ℃ (forward) |
| 长度 | 3.9 cm (1.52 in.) |
| 直径 | 3.1 cm (1.2 in.) |
| 过滤面积 | 3.5 cm2 |
| 杂质 | ≤0.25 EU/mL (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| 基质 | Durapore® |
| 孔径 | 0.22 μm nominal pore size 0.22 μm pore size |
| input | sample type liquid |
| 配件 | female Luer-Lok® inlet connection male Luer-Lok® outlet connection |
| 运输 | ambient |
