Dosing Processes and Sterility Control in Pharmaceutical Packaging: Analysis and Improvement Proposals.

With the aging population, global demographic growth, and increasing demand for well-being, pharmaceutical consumption has risen significantly in recent decades. Ensuring that medicines, particularly pharmaceutical powders, are produced with precise dosages and in compliance with regulations is essential for guaranteeing patient safety and treatment effectiveness. This thesis lies at the intersection of biomedical engineering and the pharmaceutical industry, aiming to optimize powder dosing systems in primary packaging machinery. Critical parameters, such as mechanical compression, applied vacuum, and self-regulation were analyzed, and experimental tests identified solutions to improve dosing precision and reliability. Accurate dosing ensures medications contain the correct amount of active pharmaceutical ingredient (API), reducing risks of inefficacy or toxicity. A system was also developed to optimize communication between the company and pharmaceutical clients through templates and dedicated databases, improving critical powder-related information management. In the future, this system could evolve into a digital application for more efficient and structured data exchange. Additionally, a powder testing platform was designed to assess powders in preliminary phases, identifying potential issues and reducing machinery development times. Another key aspect involves designing isolators for containing hazardous powders, such as those used in chemotherapy drugs. These systems, compliant with GMP regulations and ISO 14644-1 standards, ensure safety for operators and patients while enabling the production of complex, high-value medications. The tests and research carried out in this thesis contribute significantly to improving pharmaceutical production. It highlights the central role of biomedical engineering in optimizing production processes, ensuring the safety and efficacy of medicines, and ultimately improving patient health and societal well-being.