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      Calificación del sistema de HVAC en una planta de producción de IFA Translated title: Qualification of a HVAC (Heating, Ventilating and Air Conditioning) system in a production plant of API (Active Pharmaceutical Ingredient)

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          Abstract

          La calificación de áreas asépticas constituye uno de los requerimientos esenciales en el cumplimiento de regulaciones nacionales para la fabricación de productos estériles. Se realizó la calificación inicial (as built) de una Planta de Ingrediente Farmacéutico Activo (IFA) para la fabricación de vacunas contra tétanos, fiebre tifoidea y tos ferina. Las comprobaciones estuvieron basadas en normas internacionales y para ello se empleó un equipamiento que cumple con los requerimientos para la industria farmacéutica. Pudo comprobarse que el sistema de clima es capaz de garantizar los parámetros críticos de operación de las áreas limpias, aunque algunos criterios de pruebas opcionales no fueron cumplidos.Los resultados obtenidos sirven como referencia para el control de los parámetros del sistema de HVAC y para la toma de acciones correctivas.

          Translated abstract

          Qualification of aseptic areas is one of the essential requirements to meet national regulations for production of sterile products. Initial qualification (as built) of a plant producing Active Pharmaceutical Ingredients (APIs) for manufacturing vaccines against tetanus, typhoid fever and whooping cough, was carried out. Tests were based on international standards and they were carried out using equipment that fulfills the requirements for the pharmaceutical industry. It was proven that the climate system guarantees all operation critical parameters of clean rooms, although some approaches of optional tests were not met. Results serve as reference for controlling parameters of the HVAC system and taking corrective actions.

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          Most cited references 9

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          Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice

          (2004)
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            • Record: found
            • Abstract: not found
            • Article: not found

            EC Guide to Good Manufacturing Practice

            (2003)
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              • Record: found
              • Abstract: not found
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              ISPE Pharmaceutical Engineering Guide: Commissioning and Qualification

              (2001)
                Bookmark

                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                vac
                Vaccimonitor
                Vaccimonitor
                Finlay Ediciones (Ciudad de la Habana )
                1025-0298
                December 2006
                : 15
                : 3
                : 5-8
                Affiliations
                [1 ] Grupo Nacional de Validación Cuba
                Article
                S1025-028X2006000300002
                Product
                Product Information: website
                Categories
                BIOLOGY

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