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; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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
TOC/Conductivity
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
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 polyester support polypropylene (gamma-stable) polypropylene housing polypropylene vent cap silicone outer O-ring silicone-coated EPDM rubber lead O-ring |
| reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
| 产品线 | EMPROVE® Filter |
| 特点 | gamma compatible hydrophilic |
| manufacturer/tradename | Opticap® |
| 参数 | ≤4.6 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. differential pressure (40 psid) at 25 ℃ (Reverse; intermittent) 2.8 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 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 | 17.0 cm (6.7 in.) |
| cartridge nominal length | 4 in. (10 cm) |
| 直径 | 6.1 cm (2.4 in.) |
| 过滤面积 | 0.18 m2 |
| inlet connection diam. | 1.5 in. |
| outlet connection diam. | 1.5 in. |
| 总尺寸 | 4 in. |
| 杂质 | ≤0.5 EU/mL bacterial endotoxins (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 |
| bubble point | ≥3450 mbar (50 psig), air with water at 23 ℃ |
| 配件 | inlet hose barb 38 mm (1 outlet hose barb |
