Product category:
Particle size analysis equipment
News Release from: Micromeritics | Subject: Saturn DigiSizer 5200
Edited by the Laboratorytalk Editorial
Team on 22 December 2003
Particle sizer to 21 CFR Part 11
New software for particle size analyser meets requirements of the FDA rule and provides assurance that the system is validated for accuracy, reliability, and consistency
The all-new Confirm software was developed to address the many requirements specified by the 21 CFR Part 11 final rule published by the US Food and Drug Administration (FDA) to reduce time to market of new pharmaceutical products Combined with Micromeritics's 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
This article was originally published on Laboratorytalk on 13 Jan 2005 at 8.00am (UK)
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Automatic and validated particle sizing
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
System access is limited to authorised individuals.
Secure, computer-generated, time-stamped audit trails are an integral part of the software program.
Utilising 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. Request a free brochure from Micromeritics ...
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