Yield improvement strategy in a pharmaceutical company in central Mexico
DOI:
https://doi.org/10.64784/175Keywords:
Aseptic manufacturing, Pharmaceutical industry, Process optimization, Contamination control, Cleanroom environments, Oncology pharmaceuticalsAbstract
This study analyzes yield variability in the aseptic manufacturing of oncological injectable drugs within a Mexican pharmaceutical company, emphasizing the critical role of particle contamination control in Class A (ISO 5) environments. Drawing on industrial engineering principles and pharmaceutical quality management frameworks, the research evaluates process performance across twelve production stages, identifying the filling and stoppering phase as the primary source of yield loss.
A comparative analysis of production data from 2024 and 2025 for the product Foavil revealed a significant improvement in yield, increasing from an average of 67.36% to 92.19% following targeted process interventions. These interventions included stricter personnel gowning protocols, validation of garment cleaning cycles, elimination of particle-generating materials, and enhanced cleaning and verification of critical equipment such as transfer hoses and glass containers.
The findings confirm that deviations in aseptic practices and environmental control directly impact operational efficiency and product losses. The study highlights that robust adherence to regulatory standards, particularly NOM-059-SSA1-2015, combined with engineering-driven continuous improvement strategies, is essential to achieving high yields in sterile pharmaceutical manufacturing.
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