Efficacy of Green Chemistry Techniques in Reducing Environmental Impact of Pharmaceutical Manufacturing
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Background: Pharmaceutical preparation and manufacturing activities generate substantial solvent-driven waste and consume considerable energy, particularly in settings where controlled environments, sterilization, and repeated cleaning cycles are routine. Green chemistry offers source-reduction strategies that may lessen these burdens, yet causal evidence from real-world hospital pharmacy production settings remains limited. Objective: To evaluate the efficacy of a structured green chemistry bundle in reducing waste generation and energy consumption during routine pharmaceutical preparation in a tertiary-care hospital setting. Methods: A pragmatic parallel-group randomized controlled trial was conducted in Faisalabad, Pakistan, using 120 eligible production runs as the unit of randomization, with 60 runs allocated to standard practice and 60 to a predefined green chemistry bundle. The intervention incorporated solvent substitution and minimization, streamlined work-up and cleaning steps, and energy-efficiency measures within validated operational constraints. Primary outcomes were total waste per run and energy use per run, while secondary outcomes included a PMI-aligned material-efficiency indicator and routine quality markers. Results: The intervention reduced total waste from 23.88 to 19.23 kg/run (mean difference -4.64; 95% CI -6.34 to -2.94; p<0.001) and energy use from 94.39 to 80.09 kWh/run (mean difference -14.31; 95% CI -19.61 to -9.00; p<0.001). The PMI-aligned indicator also improved from 136.6 to 118.2 (mean difference -18.35; 95% CI -28.86 to -7.85; p<0.001). Quality failures and rework did not increase. Conclusion: A structured green chemistry bundle can reduce solvent-dominated waste, lower energy demand, and improve material-efficiency performance in hospital pharmaceutical preparation without measurable deterioration in routine quality outcomes.
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