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
closure type Red screw cap with septum and protector, ready-to-use
packaging
double packed of 12 bottles
bottle capacity
125 mL
bottle filling volume
100 mL
input
sample type pharmaceutical(s)
pH
7.1
application(s)
pharmaceutical sterility testing
compatibility
for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01), for use with Steritest®
shipped in
ambient
storage temp.
2-30°C
suitability
anaerobic bacteria
General description
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°C. The incubation temperature varies between 30-35°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 reduces the risk of cross-contamination and growth inhibition.
Application
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
Preparation Note
Fluid Thioglycollate
Analysis Note
Turbidity indicates growth
Other Notes
Screw cap with septum
Legal Information
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
Tyvek is a registered trademark of E. I. du Pont de Nemours and Company
