Saturn DigiSizer Particle Size Analyzer Offers 21 CFR Part 11 Software - 12/11/2003
Micromeritics Instrument Corporation announces the release of confirm™ software for its Saturn DigiSizer 5200 particle size analyzer. The all-new confirm software was developed to address the many requirements specified by the 21 CFR Part 11 Final Rule published by the U.S. Food and Drug Administration (FDA) to reduce time to market of new pharmaceutical products. Micromeritics’ confirm software assists with compliance to FDA regulations. Combined with Micromeritics' IQ and OQ services, the user can be assured that the system is validated for accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. System access is limited to authorized individuals. Secure, computer-generated, time-stamped audit trails are an integral part of the software program. Utilizing a state-of-the-art CCD detector, Mie theory, and unique design and data reduction features, the Saturn DigiSizer 5200 automatically measures particle sizes ranging from 0.1 to 1000 micrometers in just minutes. Optional features such as fully automated sampling, low-volume and micro-volume sample handling systems make the Saturn DigiSizer ideal for a wide range of production, research, and quality control applications.
Saturn DigiSizer II