Soybean Casein Digest Broth (TSB), Double packed STBMTSB12DP

eCl@ss:	32014001
NACRES:	NA.74

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°C. The incubation temperature varies between 20-25°C, 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.
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
Screw cap with septum
Trypticase Soy
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
Tyvek is a registered trademark of E. I. du Pont de Nemours and Company

storage conditions	Room Temperature (2 to 25 °C)
Quality Level	400,
Agency/Method	in accordance with EP 2.6.1, in accordance with JP 4.06, in accordance with USP 71
sterility	sterile; ethylene oxide treated
form	liquid
feature	ready-to-use
packaging	pkg of 100 mL, pack of 12 bottles
application(s)	cell quantification: suitable (total microorganisms), sterility testing: suitable
volume size	100 mL
input	sample type pharmaceutical(s)
pH	7.3±0.2 (25.0 °C)
Featured Industry	Pharmaceutical
compatibility	for use with Steritest®
shipped in	ambient
storage temp.	2-30°C
suitability	nonselective for

WGK Germany	WGK 2
Flash Point F	Not applicable
Flash Point C	Not applicable