Fully Automated Content Testing System

In cooperation with leading pharmaceutical companies, SOTAX has developed the new SOTAX CTS to be ideally suited for quality control departments in the routine analysis of content uniformity and assay of tablets, capsules, pellets, effervescent tablets, powder and liquids. The new CTS system has a capacity of up to 240 analyses and uses a unique mixing vessel with solvent sample volumes ranging from 25 ml up to 1000 ml. Due to this innovative design, three analyses can be processed in parallel. With the application of a modern homogenizer, equipped with a temperature detector, the user can optimize and reduce the test sample. The in-line filter station uses commercial filters such as PallTM/GelmanTM, MilliporeTM and Schleicher & Schuell TM. A high-precision Mettler-Toledo balance allows for subsequent dilutions of up to 1:40,000. Collection for sample archival is also possible with filling into HPLC or UV vials for a worry-free back-up system. Sample injection into an existing HPLC system is achieved via a full loop system. It is also possible to inject into a secondary HPLC system, to report optimal saturation and benefiting combined products. An optional UV-VIS analytical finish with drivers available for common spectrophotometers on the market can also be incorporated. Once the test has been completed, the vessel is cleaned with up to three different rinsing media and with 20 ml organic solvent. This small volume of organic solvent also results in significant cost reduction per analysis. After the cleaning cycle, which can be repeated as often as required, the vessel is dried with compressed air. The waste management system as well as the media storage vessels are integrated into the system. No additional space is needed. The SOTAX CTS has complete 21 CFR Part 11 compliant software control, reporting and LIMS access available. It has been validated on Windows 2000/XP operating systems. A full installation, validation package and support is available by your local SOTAX office. SOTAX specialises in developing and manufacturing sophisticated top-quality dissolution and physical testing equipment. More than 100 motivated and skilled employees in 9 subsidiaries on 3 continents and a comprehensive distributor network ensure SOTAX’s worldwide presence.