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 Millipore Express
Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
分析说明
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS 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 | polyethersulfone membrane polypropylene polypropylene housing polypropylene support polypropylene vent cap polysulfone silicone seal |
| reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
| 产品线 | EMPROVE® Filter |
| 特点 | hydrophilic |
| manufacturer/tradename | Millipore Express® |
| 参数 | ≤13.3 mL/min air diffusion at 2.8 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 ℃ 100 psi max. differential pressure (6.9 bar) (intermittent) 2.1 bar max. differential pressure (30 psid) at 25 ℃ (Reverse; intermittent) 2.75 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 ℃ 6.9 bar max. differential pressure (100 psid) at 25 ℃ (Forward; intermittent) 6.9 bar max. inlet pressure (100 psi) at 25 ℃ (intermittent) 80 psi max. differential pressure (5.5 bar) (continuous) 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.) |
| 过滤面积 | 0.23 m2 |
| inlet connection diam. | 1-1/2 in. |
| inlet to outlet W | 21.6 cm (8.5 in.) |
| outlet connection diam. | 1-1/2 in. |
| 总尺寸 | 5 in. |
| 杂质 | ≤0.25 EU/mL (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| 基质 | Millipore Express® SHC |
| pore size | 0.5/0.2 μm pore size |
| bubble point | ≥4000 mbar (58 psig), air with water at 23 ℃ |
| 配件 | inlet sanitary flange 38 mm (1 outlet sanitary flange |
