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> Ambika, Industry practice is to maintain usage logs for all equipment that must = be calibrated or otherwise maintained.=20 Yes, there must be a usage log for a pH meter and probe used in = production. The log must record in GMP fashion what batches the = equipment was used for. It should also record, or reference another = recording document, each standardization of the pH meter, including the = batch identification of each standardization buffer solutions used. = (Your SOP should guide on the pH's of the buffers used, which generally = state to bracket the target pH range and be no more than 2 pH units = apart. Your SOP should also guide on what the acceptable performance of = the pH probe is, which is usually the slope of the response.) The actual = performance of the probe during standardization, and that it passed or = did not, are also to be recorded in the usage log. Regards, Frank Bales, Ph.D.=20 |
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