Resumen de Development and application of analytical techniques for quality control of biologics and sterile pharmaceutical products
Microbiological testing plays an essential role in the Pharmaceutical Industry as it is an indicator of safety in drug products. The microbiological methods used in the pharmaceutical companies for testing the environment of the manufacturing process as well as the final products are based on traditional culture methods. These methods, although being appropriate for their intended use, rely on century-old technology that lacks accuracy when compared to most up-to-date methodologies for microbial detection and identification.
Every time the requirement of microbiological testing of products and processes increases, arising the need of faster and more accurate methods. In this paradigm, rapid microbiological methods (RMM) are developed for their implementation in the pharmaceutical industry encouraged by regulatory agencies. The different technologies in which rapid microbiological methods are based have been known in the academic field for decades, however their implementation and validation in the pharmaceutical industries is relatively recent.
Implementation of new methodologies in a pharmaceutical environment ruled under Good Manufacturing Practice (GMP) guidelines needs proper validation of the techniques involved. This thesis describes the implementation of RMM in the microbial monitoring of the pharmaceutical manufacturing process and products in Reig Jofré Laboratories (RJF). The main objective has been divided into three different blocks: implementation of a microbial identification program for the isolates found in the production process and products; implementation of a laser-induced fluorescence system for the detection of airborne microorganisms in cleanrooms for aseptic processing and evaluation of a solid-phase cytometry system for the detection of microorganisms in filterable products.
In general, the RMM implemented have contributed to obtain faster results which allows to mitigate contamination risk at the moment it is detected. This projects lays the ground for further applications of RMM in the pharmaceutical manufacturing process.
