Cleanrooms may be considered as a ‘system’, with people typically accounting for the largest source of airborne particulate contamination and the cleanroom’s air handling system designed to remove this contamination. The balance between incoming contamination and the removal of contamination is designed to deliver the required air quality of the cleanroom ‘system’ to meet the requirements of the processes.
Why is data integrity important? Routine monitoring data can be trended to detect any deviations or tendency to drift towards an out-of-specification (OOS) situation that may threaten product quality. However, if the data integrity cannot be relied upon, either through frequent manual data transcription errors, or through poor particle counter-to-counter measurement issues, then the benefit of data trending can be called into question.
Improvements in data integrity are encouraged by the regulatory expectations of EU GMP Annex 11 and the FDA’s 21 CFR part 11 documents, driving users to seek more robust and secure methods of collecting and storing portable particle counter data. Manual data transcription from particle counter paper printouts into data trending and archiving systems is no longer an option.
Poor data integrity can lead to false data points that seem to indicate an OOS event. The resulting root cause investigation may not be able to identify that there had been a transcription error or that the error was due to poor particle counter performance and the investigation may be left unresolved.
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