Description
General description
FTM with 0.5% Tween® 80 also known as Fluid Thioglycollate Medium is a nutrient rich medium designed as a sterility control for pharmaceutical products.
Thioglycollate and L-Cystine in the medium reduces the redox potential of the medium to create an anaerobic atmosphere. Also, it deactivates the presence of mercury and other heavy metals.
The presence of agar further reduces oxygen diffusion and resazurin indicates the reduced oxygen potential in the medium. An increased oxygen concentration will render a color change from yellow to pink in the medium.
Polysorbate 80 inactivates benzyl alcohol, carbanilides, dichlorbenzyl alcohols, benzoic acid, p-hydroxybenzoic acid and its esters, phenols, phenylethyl alcohols and PHB esters. Histidine is effective against formaldehyde and formaldehyde releasing agents.
Application
FTM with 0.5% Tween® 80 is used to isolate and cultivate fastidious anaerobic and aerobic microbes in test samples. FTM is suitable as a sterility control of pharmaceutical products.
Fluid Thioglycollate Medium is recommended for sterility testing of samples according to EU and US pharmacopeia.
Features and Benefits
Our ready-to-use media provide the highest level of quality and testing confidence. They are formulated and tested to meet the pharmacopeia requirements.
Sterility testing media and rinse solutions are manufactured in an ISO 9001, environmentally controlled production center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility, and growth promotion tests.
Our manufacturing approach ensures the highest level of clarity for our media and rinsing fluids, thus improving accuracy, and reducing the risk of incorrect interpretation and false results.
Other Notes
Production will take place at Millipore SAS in Molsheim, France. Deliveries will be executed in accordance with the terms and conditions of MLS RTU GmbH. A minimum order quantity is required to process the order. Once the order is placed and confirmed, Merck will ensure product delivery within a maximum timeframe of 10 to 12 weeks. The terms and conditions of Merck KGaA apply to both Millipore SAS and MLS RTU GmbH and can be accessed through the following link: Standard Terms & Conditions
This medium can be modified and/or supplemented based on the required performance criteria.
Legal Information
TWEEN is a registered trademark of Croda International PLC
Disclaimer
This item is created at the customer′s request as a customized product and will not be developed or qualified in accordance with the Merck Product Development Process.
