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Ultra-Pure Water Particle Measurements: Factors Affecting Stabilization Time
Ultra-pure water particle measurements can take a long time to return to a stable baseline after an event interruption. Learn about factors affecting stabilization time.
Ultra-pure water particle measurements can take a long time to return to a stable baseline after an event interruption. Learn about factors affecting stabilization time.
ISO 14644-1:2015 introduces the need for particle counters calibrated to ISO 21501-4. The calibration methods assure data accuracy and repeatability. The methods outlined in ISO 14644 and ISO 21501-4 represent an important step in more accurate evaluations of cleanroom contamination and improved process control.
Pharmaceutical manufacturing environments have traditionally seen particle counting as a burden required to demonstrate compliance to a cleanroom standard. Now, however, Process Analytical Technologies (PAT) changes the focus to be on the final quality of the product…
In discussing acceptable particle losses in tubing, there are many factors. Transportation of particles in tubing between a sample inlet and the optics of particle counters has at many times been at the forefront of discussion regarding the truth of readings. When the validation implications of losses due to various forces are reviewed, the certainty of the result is always in question. So, what are these forces, what are the losses, and what are the acceptable results? This paper addresses these issues to allow for a better understanding of the problem.