La virtualización y análisis en tiempo real de productos farmacéuticos y alimenticios por espectroscopia de infrarrojo cercano
- Autores: Dong Sun
- Directores de la Tesis: Manel Alcalà Bernàrdez (dir. tes.), Marcel Blanco Romia (dir. tes.)
- Lectura: En la Universitat Autònoma de Barcelona ( España ) en 2017
- Idioma: español
- Tribunal Calificador de la Tesis: Jordi Coello Bonilla (presid.), Sergio Armenta (secret.), Josep Sabaté Reboll (voc.)
- Programa de doctorado: Programa Oficial de Doctorado en Química
- Materias:
- Enlaces
- Tesis en acceso abierto en: TESEO
- Resumen
The realization of the smart factory has been investigated in this Thesis. The smart factory is a trend of development in the information age. Human beings could receive a lot of assistance from the smart tools which make works be done in a high quality way. Technology-intensive industries, such as pharmaceutical and modern food industries, are pioneers who have the advantages to enjoy the smart factory. Nowadays, the product quality is a key factor that determines the market share. In order to assure a high quality both in the process and final product, several institutions have published some guidelines. Quality by Design (QbD) and Process analytical technology (PAT) were two guidelines used in this thesis for the pharmaceutical methods. Near infrared spectroscopy (NIRS) could virtualize the physical and chemical information of the process product in real time. Therefore, it was taken as the smart tool to realize these concepts in the pharmaceutical industry and study about the food quality improvement. A portable MicroNIR spectrometer was used to determine critical quality attributes in different stages of the pharmaceutical process for the manufacturing of solid formulations. Quantitative partial least-squares regression models were calculated and validated. The MicroNIR has a miniaturized size, low energy consumption and rugged optical system. So it has shown a good robustness in the operation process. The experiment design has offered a simple way to calculate the models without a complex reference method. The good results of validation reveal that the MicroNIR is an excellent PAT tool in the pharmaceutical industry. The MicroNIR was also adopted to calculate and validate a spectral library to identify 223 pharmaceutical formulations. The internal and external validations have shown that all the formulations can be uniquely identified. This simple and nondestructive method has offered the customer a simple tool to qualify the pharmaceutical product in the retail stores. Besides, the benchtop NIR spectrometer was also adopted to analyze several chemical and sensory parameters of tomato. The analysis was operated in real time mode without any sample pretreatment. The quantitative models were calculated by PLS. The predictive ability was good and it was demonstrated that NIRS is a robust, accurate and safe method to improve the quality of tomato product.
Based on the discussion above, this Thesis has studied the application of NIRS as a tool to virtualize and real time analyze pharmaceutical and food industries. All these studies have indicated that the NIRS is a suitable technology for the realization of the smart factory.
