1. Evaluación de procesos de producción de componentes de los diagnosticadores fabricados en Laboratorios DAVIH.
- Author
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Martín-Alfonso, Dayamí, Alfonso-González, Martha Julia, Fragas-Quintero, Anitza, Pérez-Guevara, María Teresa, and Silva-Cabrera, Eladio
- Subjects
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MANUFACTURING processes , *PRODUCTION (Economic theory) , *FREEZE-drying , *STERILIZATION (Disinfection) , *SIMULATION methods & models - Abstract
The validation of manufacturing process is one of the principal requirements for the quality assurance, in biopharmaceutical industry. In this paper are shown the evaluation of the components production for diagnostic system that are produced in DAVIH Laboratories. The critical processes: the sterilization, lyophilization, preparation of liquid components and the tightness of the components packing were validated in four protocols using specific simulation methodologies for each one. The simulation proceedings revealed the main vulnerabilities in each operation. The sterilization and lyophilization were valid operations but the preparation of liquid components and the tightness of polylaminate component were critical operations. These results represent the first documental validation evidences in this type of product in DAVIH Laboratories. [ABSTRACT FROM AUTHOR]
- Published
- 2015