High resolution laser particle size analyser automatically measures particle sizes ranging from 0.1 to 1000 micrometers in just minutes and now has 21 CFR Part 11 software
Utilising a state-of-the-art CCD detector, Mie theory, and unique design and data reduction features, Micromeritics says its 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, the company says.
In addition, Micromeritics's Confirm 21 CFR Part 11 software assists with compliance to FDA regulations. Combined with the company's IQ and OQ services, it says the user can be assured that the Saturn DigiSizer system is validated for accuracy, reliability, consistent intended performance, and provides safeguards to protect the integrity of analysis records. System access is limited to authorised individuals.
Secure, computer-generated, time-stamped audit trails are an integral part of the software program.
