Collaboration will provide pharmaceutical customers with a high-quality, complete, and automated turnkey system supporting various pharmacopoeia methods
Thermo Electron has concluded an OEM agreement with Sotax, whereby Sotax dissolution baths will be offered with Thermo's Nicolet Evolution 300 UV-vis spectrophotometer. This collaboration will provide pharmaceutical customers with a high-quality, complete, and automated turnkey system supporting various pharmacopoeia methods.
Sotax's dissolution baths employ hollow-shaft sampling technology and the company's Autocompliance concept, which simplifies bath validation.
The company is also a pioneer in flow-through dissolution and automated testing solutions.
These high-quality, innovative dissolution and tablet testing tools meet and exceed USP and FIP guidelines, says Thermo.
WinSotax dissolution software offers the tools necessary to achieve 21 CFR Part 11 compliance.
Thermo says its Nicolet Evolution 300 UV-vis spectrophotometer is the first UV-vis product on the market that uses the Smart Accessory sampling concept, thereby providing automatic accessory and serial number recognition, initialisation, and logging.
Enhanced and automated validation qualification performed with Nist or NPL traceable standards and primary standard mercury emission lines are also an integral part of this unique system.
The new combined system will include control of up to two dissolution baths with a single UV-vis instrument, state-of-the-art validation and software tools allowing customers to achieve 21 CFR Part 11 compliance.
It will also offer customers a more convenient and tailor-made solution incorporating qualification and validation tools in order to streamline processes.
