Browsing by Author "Morales, Jimmy (Director)"
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Item Fuentes de contaminación por endotoxinas bacterianas en medicamentos inyectables dentro de la industria farmacéutica(Universidad Santiago de Cali, 2025) Romero Solís, Darwin Alexis; Morales, Jimmy (Director)This systematic review highlights the issue of bacterial endotoxin contamination in injectable medications, a critical factor for patient safety and pharmaceutical product quality. The objective was to identify the main sources of contamination, evaluate the available detection methods, and analyze the prevention and control strategies implemented in the industry. Through a systematic review of the literature, relevant research on microbial biofilms, analytical methods such as the Limulus Amebocyte Lysate (LAL) assay, and emerging technologies like electrochemical biosensors were analyzed. The results showed that microbial biofilms and inadequate handling of equipment and raw materials are the primary sources of contamination. Although the LAL assay is widely used, it has limitations related to chemical interferences and false results, underscoring the need for more advanced alternatives. Emerging technologies, such as biosensors and artificial intelligence tools, offer significant potential to optimize endotoxin detection and monitoring. Additionally, strategies such as the implementation of continuous monitoring systems, process automation, and personnel training were identified as key measures to mitigate risks. It is concluded that an integrated approach combining technological innovation, regulatory compliance, and inter institutional collaboration is essential to improve quality and safety standards in the pharmaceutical industry. This review highlights the need for new research lines, including the development of accessible technologies and unified international protocols.