Analysis Note

Turbidity indicates growth

Application

Sterility testing (membrane filtration and direct inoculation)Bioburden testing

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.

Components

Screw cap with septum

Culture Medium

Trypticase Soy

General description

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. 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 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°C. The incubation temperature varies between 20-25°C, with an incubation time of 7-14 days. One box of product contains 12 bottles of 100ml of Medium. Each bottle has a screw cap with a septum, which minimizes the risks of cross-contamination and optimizes the disinfection procedures.

Legal Information

STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

Specifications

Incubation Time: 7–14 days

United-States Pharmacopeia, European Pharmacopeia, Japanese Pharmacopeia

Incubation Temperature: 20–25 °C