产品介绍：
产品说明
一般描述
T-line/Gauge Port: T-line
Device Configuration: 取样皿滤膜
特点和优势
Format: Single Layer
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 reduction
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
制备说明
Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
分析说明
Gravimetric Extractables: after 24 hours in water at controlled room temperature
法律信息
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD 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 | polypropylene polypropylene housing polypropylene support polypropylene vent cap silicone seal |
| reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
| manufacturer/tradename | Opticap® |
| 参数 | 25 ℃ max. inlet temp. 80 psig max. inlet pressure |
| cartridge nominal length | 30 in. (75 cm) |
| inlet connection diam. | 1.5 in. |
| outlet connection diam. | 1.5 in. |
| 总尺寸 | 30 in. |
| 杂质 | ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| gravimetric extractables | ≤165 mg/capsule |
| 基质 | Polygard®-CN |
| 孔径 | 1.2 μm nominal pore size 1.2 μm pore size |
| input | sample type liquid |
| 配件 | inlet sanitary flange 38 mm (1 outlet sanitary flange |
