Final answer:
The minimum cleanroom requirement under USP 797 is met when at least 59 out of 60 replicates in disinfectant efficacy tests show no growth, and results are repeatable across different batches and days.
Step-by-step explanation:
The minimum cleanroom requirement under USP 797 essentially refers to the standards for preparing compounded sterile pharmaceuticals to ensure patient safety and product quality. When it comes to disinfectant testing, the Association of Official Agricultural Chemists International (AOAC) has determined a strict criterion that applies to the efficacy of disinfectants within these environments. To comply with AOAC standards and demonstrate the efficacy of a disinfectant, a minimum of 59 out of 60 replicates must show no growth of bacterial contamination. Additionally, these results must be consistent and repeatable across various batches of disinfectant and on different days to confirm that the cleanroom meets the minimum requirement for sterility.