Identification of bacterial hazards in the production of artisan fresh cheese in Cuba.

Artisan fresh cheese producing farms from six provinces of Cuba were studied to identify the presence of bacterial hazards and the results are presented in this research communication. The bacterial hazards identified in milk and cheese respectively were: Listeria spp. (9.5 and 18.9%), Bacillus cereus (23.2 and 24.2%), Escherichia coli O157 (12.6 and 13.7%), Salmonella spp. (10.5 and 17.9%), and Staphylococcus aureus (29.5 and 51.6%). Listeria monocytogenes was not detected. Nine Salmonella serotypes corresponding to Salmonella enterica subsp. enterica and Salmonella enterica subsp. arizonae were isolated, whereas Salmonella Anatum was present most often. Biofilm formation by the isolated species and enterotoxin production by S. aureus strains demonstrated the pathogenic potential of the identified bacterial hazards. Results proved the presence of bacterial hazards in the raw milk and cheeses analyzed, so that good manufacturing practices must be accomplished throughout the entire production process in order to avoid the occurrence of foodborne diseases in the population.

Safety of the production process of SURFACEN(®) to inactivate and remove virus.

SURFACEN(®) is a biological product produced from pig lungs. Since these animals can be potential sources of microbial pathogens such as viruses, the manufacturing process of this product should guarantee safety from health hazards. The SURFACEN(®) production procedure is capable of effective viral clearance (inactivation/removal) by involving two stages of organic solvent extraction followed by acetone precipitation and heat treatment. In this study, we evaluated the clearance capacity of these four stages for a wide range of viruses by performing spiking experiments. Residual contamination was assessed using a Tissue Culture Infectious Dose assay (log10 TCID50). The validation study demonstrated that, for all viruses tested, the TCID50 titers were reduced by more than 2 log10 in each stage. Total log reduction values achieved were between ≥17.82 log10 and ≥27.93 log10, depending on the virus physical properties, titer, and the number of processing stages applied. Results indicated that the production procedure of SURFACEN(®) can inactivate or remove contaminant viruses from the raw material.

Metodología para elaborar el Plan Maestro de Validación de los procesos de producción del Centro Nacional de Sanidad Agropecuaria / Methodology to design the Master Plan of Validation of production processes of National Center of Agricultural Health

La metodología para la elaboración del Plan Maestro de Validación de los procesos de producción del Centro Nacional de Sanidad Agropecuaria, se diseñó a partir de los requisitos contenidos en la Regulación 16 del 2006 de Buenas Pràcticas de Fabricación de medicamentos. Abarcó la política de la organización para la actividad de validación su estructura organizativa, las instalaciones, sistemas, equipos y procesos que se deben validar; el formato de la documentación a utilizar; la planificación y calendario de cada actividad; los resultados de cada protocolo ejecutado, el control de los cambios que se generan; un resumen de las validaciones anteriores; cumplimiento del plan propuesto; las conclusiones donde se precisan de forma resumida si los procesos validados estàn bajo control, los resultados màs relevantes, así como las acciones correctivas y preventivas a tomar; por último se define la distribución de toda la información generada, conformando así el Plan Maestro de Validación. Este sistema de validación se muestra a través de procedimientos, protocolos y registros aplicados en el proceso de fabricación de Surfacen®, medicamento para uso humano que se fabrica en el Centro Nacional de Sanidad Agropecuaria.

The methodology to design the Validation Master Plan the production processes of National Center of Agricultural Health was created from the requirements present in the Regulation 16, 2006 of Good Practices of drugs manufacture including the organization policy for validation activity of its organizing structure, installations, systems, equipments and processes to be validated, documentation format used, planning and calendar of each activity; the results from each protocol performed, the generating changes control, abstract of prior validations, fulfillment of proposed plan, conclusions where are determined in a summarized way if the validated processes are under control, the more relevant results, as well as how the corrective and preventive actions executed, and lastly, the distribution of all the generated information is defined, thus creating the validation of Master Plan. This validation system is showed thorough procedures, protocols and registries applied in manufacturing process of Surfacen® a human use drug manufactured in the National Center of Agricultural Health.

Metodología para elaborar el Plan Maestro de Validación de los procesos de producción del Centro Nacional de Sanidad Agropecuaria / Methodology to design the Master Plan of Validation of production processes of National Center of Agricultural Health

La metodología para la elaboración del Plan Maestro de Validación de los procesos de producción del Centro Nacional de Sanidad Agropecuaria, se diseñó a partir de los requisitos contenidos en la Regulación 16 del 2006 de Buenas Pràcticas de Fabricación de medicamentos. Abarcó la política de la organización para la actividad de validación su estructura organizativa, las instalaciones, sistemas, equipos y procesos que se deben validar; el formato de la documentación a utilizar; la planificación y calendario de cada actividad; los resultados de cada protocolo ejecutado, el control de los cambios que se generan; un resumen de las validaciones anteriores; cumplimiento del plan propuesto; las conclusiones donde se precisan de forma resumida si los procesos validados estàn bajo control, los resultados màs relevantes, así como las acciones correctivas y preventivas a tomar; por último se define la distribución de toda la información generada, conformando así el Plan Maestro de Validación. Este sistema de validación se muestra a través de procedimientos, protocolos y registros aplicados en el proceso de fabricación de Surfacen®, medicamento para uso humano que se fabrica en el Centro Nacional de Sanidad Agropecuaria(AU)

The methodology to design the Validation Master Plan the production processes of National Center of Agricultural Health was created from the requirements present in the Regulation 16, 2006 of Good Practices of drugs manufacture including the organization policy for validation activity of its organizing structure, installations, systems, equipments and processes to be validated, documentation format used, planning and calendar of each activity; the results from each protocol performed, the generating changes control, abstract of prior validations, fulfillment of proposed plan, conclusions where are determined in a summarized way if the validated processes are under control, the more relevant results, as well as how the corrective and preventive actions executed, and lastly, the distribution of all the generated information is defined, thus creating the validation of Master Plan. This validation system is showed thorough procedures, protocols and registries applied in manufacturing process of Surfacen® a human use drug manufactured in the National Center of Agricultural Health(AU)