Monday, 17 June 2019

Cleanroom Particle Counting: Assessing Data for Trends and Patterns


Given the requirement for particle count trending it is surprising that there is little published on the subject and a paucity of examples for the reader to assess. While there are many different approaches that can be taken, improvements to quality reporting are driven through example. To partly address the shortfall of literature on particle count trending, this paper considers some different ways to assess particle data, in terms of routine assessments and where a statistical comparison of data is required. With the latter, this is less straightforward given that particle count data does not follow normal distribution.

In relation to this, Tim Sandle has written a new paper. The reference is:

Sandle, T. (2019) Cleanroom Particle Counting: Assessing Data for Trends and Patterns, Journal of GxP Compliance, 23 92): 1-10

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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