产品说明
一般描述
Fluid Thioglycollate Medium (FTM) is a critical component of our STERITEST® solution. The product has been formulated and tested to meet the requirements of the EP 2.6.1, USP 71, and JP 4.06. Our manufacturing approach ensures the highest level of quality for our media, improves accuracy and significantly reduces the risk of incorrect interpretation and false results. The sterilized double Tyvek® packaging allows to streamline the cleaning procedures, to minimize the risk of cross-contamination in laminar flow hoods and to secure an efficient decontamination of isolator chambers. The fluid appears light yellow, slightly opalescent and viscous with a pink ring in suspension ≤ 1 cm. The pH of the product is 7.1 ± 0.2 and can be stored at 2-25℃. The incubation temperature varies between 30-35℃, with an incubation time of 7-14 days. The product is supplied as 12 bottles of 100 mL of medium, screw cap with septum closure that reduces the risk of cross-contamination and growth inhibition.
应用
Fluid Thioglycollate Medium (FTM) is primarily used for the detection of anaerobic bacteria. However, it also enables aerobic bacterial detection. The QC organisms include Clostridium sporogenes (ATCC 19404), Staphylococcus aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027). This medium is used for sterility testing by membrane filtration or direct inoculation.
Sterility testing (membrane filtration and direct inoculation)
Bioburden testing
组分
Screw cap with septum
培养基
液体硫乙醇酸盐
分析说明
Turbidity indicates growth
法律信息
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
Tyvek is a registered trademark of E. I. du Pont de Nemours and Company
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; ethylene oxide treated |
| 形式 | liquid |
| 特点 | ready-to-use |
| 包装 | pkg of 100 mL pack of 12 bottles |
| 体积尺寸 | 100 mL |
| input | sample type pharmaceutical(s) |
| pH值(酸碱度) | 7.1±0.2 (25 ℃) |
| application(s) | pharmaceutical sterility testing |
| 相容性 | for use with Steritest® |
| 运输 | ambient |
| 储存温度 | 2-30℃ |
| 适用性 | anaerobic bacteria |
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 |
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