Monday, 10 June 2019

Cleanroom Particle Counting: Assessing Data for Trends and Patterns

Airborne particulate content relating to pharmaceuticals and healthcare can be classified as viable or non-viable contaminants and may originate from humans (such as skin matter) or from areas of production (such as opening packaging materials and operating centrifuges or vortexes). The assessment of particles provides the basis of cleanroom classification; however, particle counting is not only an exercise undertaken to assess cleanrooms as part of classification exercises, since particle counting of GMP areas needs to be undertaken on a regular basis in order to show on-going compliance (notwithstanding that a cleanroom that meets the particle concentration requirements, but does not result in the desired level of bioburden, will clearly be inadequate). Ongoing compliance is best assessed by looking at data patterns over time and by comparing cleanrooms in different states, for different activities, and at different time points. Indeed, both ISO 14644-2: 2015 and EU GMP Annex 1 recommend regular assessments and the examination of data patterns by trending.

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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