Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. It makes an impact at almost every step of the journey, from early product development to late-stage quality control in commercial manufacturing. Given its importance throughout the course of drug development and manufacturing, dissolution testing has become a key concern for regulatory bodies – so the dissolution apparatus you depend on must provide the most accurate and reproducible results available.
To meet U.S. and E.U compliance guidelines, you need confidence in your compliance regiment, up and down the workflow. Working with the FDA/USP our teams have contributed to vibration limit evaluations and settings, including mechanical calibration and USP Performance Verification Test (PVT) services. Our OneSource services teams are staffed with engineers and consultants who know the ins and outs of dissolution testing and we provide technologies that produce clear, useful, and fully integrated reports so that you can stay compliant throughout the process. With 21 CFR part 11 software available, our state-of the-art UV/Vis instrumentation meets the needs of pharmaceuticals and manufacturing QA/QC analysts everywhere.
The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses pharmacopeial (USP, EP, and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer.
OneSource Compliance Services ensures the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.
Unleash the power of your LAMBDA UV/Vis spectrophotometer with UV WinLab software designed for operational simplicity and the power to address the most challenging analyses. Our Enhanced Security™ (ES) UV WinLab software is designed for busy pharmaceutical, manufacturing, industrial, food, or academic laboratories in regulated environments that require compliance with US FDA 21 CFR Part 11 regulations.
The LAMBDA™ 365 delivers state-of-the-art UV/Vis performance that meets the needs of analytical chemists working in CMC testing in drug development and QA/QC manufacturing everywhere. With 21 CFR Part 11 compliant software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.
We test and validate our complete portfolio of solutions to ensure that you receive accurate, repeatable results, on time, every time, throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.