产品说明
一般描述
Fluid D is suitable for testing samples that contain lecithin or oil, and compatible with most antibiotics. Composition of this fluid comply with the European Pharmacopeia (EP) 2.6.1, United States Pharmacopeia (USP) 71 and Japanese Pharmacopeia (JP) 4.06. This is a clear colorless fluid and the pH of the product is 7.1 ± 0.2 at 25℃. It can be stored at 2-25℃ (protected from light) for 17 months. One box of product contains 4 bottles of 300 mL of fluid. Each bottle has a screw cap with a septum to minimize the risks of cross-contamination and optimize the disinfection procedures.
应用
Sterility testing
Bioburden testing
Fluid D can be used in combination with the STERITEST® sterility testing system for the rinsing of solutions containing oil or lecithin during sterility testing by membrane filtration. It can also be used for the removal of antimicrobial activity by membrane filtration for non-sterile products. The fluid is also excellent for rinsing sterile pathways of devices, and typically used for rinse method testing of medical devices.
组分
装有隔膜的螺旋盖
产品规格
美国药典、欧洲药典、日本药典
培养基
冲洗液 D
分析说明
QC organisms
S. aureus (ATCC 6538)
B. subtilis (ATCC 6633)
P. aeruginosa (ATCC 9027)
C. albicans (ATCC 10231)
A. niger (ATCC 16404)
生孢梭菌 (ATCC 11437)
Target Microorganisms: 清洗缓冲液和附加剂
法律信息
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
基本信息
| eCl@ss | 32014001 |
| NACRES | NA.74 |
产品性质
| 质量水平 | 400 |
| agency | in accordance with EP 2.6.1 in accordance with JP 4.06 in accordance with USP 71 |
| 无菌性 | sterile; autoclaved |
| 形式 | liquid |
| 保质期 | 17 mo. |
| 特点 | ready-to-use |
| 包装 | pkg of 300 mL (Bottle with screw cap and septum) pack of 4 bottles |
| 体积尺寸 | 300 mL |
| 颜色 | clear, with no precipitate and free of visible particles |
| input | sample type pharmaceutical(s) |
| pH值(酸碱度) | 7.1±0.2 (25.0 ℃) |
| application(s) | pharmaceutical sterility testing |
| 相容性 | for use with Steritest® |
| 运输 | ambient |
| 储存温度 | 2-30℃ |
| 适用性 | nonselective for |
安全信息
| 储存分类代码 | 12 - Non Combustible Liquids |
| WGK | WGK 1 |
| 闪点(F) | Not applicable |
| 闪点(C) | Not applicable |
