产品说明
一般描述
Soybean Casein Digest Broth is a sterility medium and a critical component of our STERITEST® solution. Composition and growth performance of this medium comply with the European Pharmacopeia (EP) 2.6.1, United States Pharmacopeia (USP) 71 and Japanese Pharmacopeia (JP) 4.06, for Soybean-Casein Digest Medium. Our manufacturing approach ensures the highest level of quality for our media, improving accuracy and significantly reducing the risk of incorrect interpretation and false results. The sterilized double Tyvek® packaging increases the test method reliability, allowing to streamline the cleaning procedures, minimize the risk of cross-contamination in laminar flow hoods and secure an efficient decontamination of isolator chambers. The appearance of the media is a light-yellow clear liquid. It has a pH of 7.3 ± 0.2 and the storage temperature is 2-25℃. The incubation temperature varies between 20-25℃, 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 minimizes the risks of cross-contamination and optimizes the disinfection procedures.
应用
Soybean-Casein Digest Medium is intended for the detection of aerobic bacteria and fungi. The QC organisms include Bacillus subtilis (ATCC 6633), Candida albicans (ATCC 10231), Aspergillus brasiliensis (niger) (ATCC 16404), Staphylococcus aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027). This medium is used for sterility testing by membrane filtration or direct inoculation. It is also used as a pre-enrichment broth for nonsterile products.
Sterility testing (membrane filtration and direct inoculation)
Bioburden testing
组分
Screw cap with septum
培养基
TSA
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 |
| technique(s) | cell counting: suitable (total microorganisms) |
| 体积尺寸 | 100 mL |
| input | sample type pharmaceutical(s) |
| pH值(酸碱度) | 7.3±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 2 |
| 闪点(F) | Not applicable |
| 闪点(C) | Not applicable |
