Many
laboratory managers have given attention to automated, digital devices to
streamline the plate counting processes. Such devices have been commonplace to
the clinical laboratory for some time; although adoption within pharmaceutical
laboratories has been slower. Recent regulatory interest in data integrity and
the economic pressures driving the ‘lean’ laboratory, with a focus on cost
control, improving sample throughput, and reviewing whether each sample tested
adds value or produces meaningful information, may account for the growing
interest.
This
paper considers the selection and adoption of automated, digital capture colony
counters within the pharmaceutical microbiology laboratory. The focus is on how
such devices can be qualified (or validated) and how data integrity concerns
can be addressed, provided that the former has been appropriately planned and
executed.
To
understand how these devices work, and how accurate they are, plus how data
integrity considerations must be handled, Tim Sandle has written a paper for
the Journal of GxP Compliance.
The
reference is:
Posted by Dr. Tim Sandle
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Pharmaceutical Microbiology Resources