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 Wetting Instructions for Filter Units with Durapore® Membrane 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 60 min @ 126 °C; not in-line steam sterilizable
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
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
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
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove 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
产品性质
| 质量水平 | 400 |
| 物料 | PVDF 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) |
| 无菌性 | sterile |
| 产品线 | EMPROVE® Filter |
| 特点 | hydrophilic |
| manufacturer/tradename | Opticap® |
| 参数 | ≤6.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 ℃ (in water) 1.0 bar max. differential pressure (15 psid) at 80 ℃ (Forward) 1.0 bar max. inlet pressure (15 psi) at 80 ℃ 2.8 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 3.4 bar max. differential pressure (50 psid) at 25 ℃ (Reverse; intermittent) 5.5 bar max. differential pressure (80 psid) at 25 ℃ (Forward) 5.5 bar max. inlet pressure (80 psi) at 23 ℃ 80 psig max. inlet pressure |
| 长度 | 21.0 cm (8.3 in.) |
| cartridge nominal length | 5 in. (12.5 cm) |
| 直径 | 14.5 cm (5.7 in.) |
| 过滤面积 | 0.34 m2 |
| inlet connection diam. | 3/4 in. |
| inlet to outlet W | 21.0 cm (8.3 in.) |
| outlet connection diam. | 3/4 in. |
| 总尺寸 | 5 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 | ≤15 mg/capsule |
| 基质 | Durapore® |
| 孔径 | 0.22 μm nominal pore size 0.22 μm pore size |
| input | sample type liquid |
| bubble point | ≥3450 mbar (50 psig), air with water at 23 ℃ |
| 配件 | inlet sanitary flange 19 mm ( outlet sanitary flange |
