产品说明
一般描述
Device Configuration: 取样皿滤膜
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 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
This product was manufactured with a media combination 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 30 min @ 126 °C; not in-line steam sterilizable
分析说明
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
法律信息
CLARIGARD 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
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 | 1.0 bar max. inlet pressure (15 psi) at 80 ℃ 2.75 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 4.8 bar max. differential pressure (70 psid) at 20 ℃ 5.5 bar max. inlet pressure (80 psi) at 23 ℃ 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.) |
| inlet connection diam. | 9/16 in. |
| inlet to outlet W | 21.6 cm (8.5 in.) |
| outlet connection diam. | 9/16 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) |
| gravimetric extractables | ≤10 mg/capsule |
| 基质 | Clarigard® |
| 孔径 | 0.3 μm nominal pore size 0.3 μm pore size |
| input | sample type liquid |
| 配件 | inlet hose barb 14 mm ( outlet hose barb |
