产品介绍：
产品说明
一般描述
Device Configuration: Cartridge
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
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).
Sterilization Method
100 SIP cycles of 30 min @ 109 °C; hot water sanitized 30 times for 30 min @ 80 °C maximum
分析说明
Gravimetric Extractables: after 24 hours in water at controlled room temperature
法律信息
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
VITIPORE 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 | PVDF polypropylene polypropylene support silicone seal |
| reg. compliance | meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food) meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
| 无菌性 | sterile |
| 特点 | hydrophilic |
| manufacturer/tradename | Vitipore® |
| 参数 | ≤45.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 ℃ (in water) 0.35 bar max. differential pressure (5 psid) at 135 ℃ (Forward) 1.7 bar max. differential pressure (25 psid) at 80 ℃ (Forward) 3.5 bar max. differential pressure (50 psid) at 25 ℃ (Reverse; intermittent) 5.5 bar max. differential pressure (80 psid) at 25 ℃ (Forward) |
| cartridge nominal length | 30 in. (75 cm) |
| 直径 | 6.9 cm (2.7 in.) |
| 过滤面积 | 2.34 m2 |
| 总尺寸 | 30 in. |
| gravimetric extractables | ≤69 mg/cartridge |
| 基质 | Vitipore® II |
| 孔径 | 0.22 μm nominal pore size 0.22 μm pore size |
| input | sample type liquid sample type food(s) sample type beverage(s) sample type wine sample type beer sample type bottled water |
| bubble point | ≥3100 mbar (45 psig), air with water at 23 ℃ |
| cartridge code | Code 0 (2-222; O-rings) |
