Understanding Particle Counter technology, the risks of particle count data integrity and the importance of ISO 21501-4 calibration
In effect these devices have so much computing technology embedded that they really need to be validated to ensure they meet your process requirements and with so much focus on data integrity and the FDA’s ALCOA approach this paper takes a deep dive into Particle Counter technology more than we have ever seen previously which will help to assist decision makers in making informed choices when considering which option/model is best for their process when data integrity is of paramount importance to them.
It is important to also acknowledge the advantages of an ISO 21501- 4 calibration. ISO 21501-4 is a major particle counter calibration standard and one of the most complete guidelines and it is important that particle counters are calibrated to meet this standard as this calibration allows for better accuracy and reliability which in turn mitigates data integrity issues by verifying count data is as accurate as it can be, therefore it is important to understand the relationship between ISO 14644-1:2015 and ISO 21501-4:2007. Overall the objective of this article is to increase your knowledge in Particle Counting technology so you are more aware and experienced as particle counters play such an important role in the front line of defense against contamination in your Cleanroom. Click HERE for more.