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)
cosmetics food and beverages 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, nonselective for
General description
Clear Thioglycollate medium has the same growth promotion properties as the standard Fluid Thioglycollate Medium (FTM). The alternative formulation brings extra visual clarity versus the FTM which has a slight turbidity or haze. 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 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 appearance of the fluid is light yellow and viscous liquid 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 for 12 months. The incubation temperature varies between 30-35°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 that minimizes the risks of cross-contamination and optimizes the disinfection procedures.
Application
Clear Fluid Thioglycollate Medium is intended for the detection of anaerobic bacteria however, it also enables aerobic bacterial detection. This medium is used for sterility testing by membrane filtration or direct inoculation. The QC organisms include Clostridium sporogenes (ATCC 19404), Staphylococcus aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027).
Sterility testing (membrane filtration and direct inoculation) Bioburden testing
Preparation Note
Clear 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
