1025-028X 1025-028X S1025-028X2006000300002 Cuba 00 12 2006 00 12 2006 15 3 5 8

ARTICULOS ORIGINALES

 

Calificación del sistema de HVAC en una planta de producción de IFA.

Qualification of a HVAC (Heating, Ventilating and Air Conditioning) system in a production plant of API (Active Pharmaceutical Ingredient).

Otto Reyes, Lissette M. Luis, Rodney Pérez, Gerardo Limia

Grupo Nacional de Validación. Calle 25 No. 222A14 e/ 222A y 230. La Giraldilla, La Lisa. Ciudad de La Habana. Cuba. E-mail: oreyes@finlay.edu.cu

RESUMEN

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.

Palabras claves: Calificación de áreas limpias, integridad de filtros HEPA, conteo de partículas.

ABTRACT

]]> 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.

Keywords: Qualification of clean rooms/ HEPA filter leak test/ room particle count.

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REFERENCIAS

1. Working Group 006 of the Standards and Practices Committee of the Institute’s Contamination Control Division: “IES-RP-CC006.2. Testing Clean Rooms». Institute of Environmental Sciences. United States. 1997.
2. EC Guide to Good Manufacturing Practice. Revision to Annex 1. 2003.
3. ISO.14644-1:” Cleanrooms and Associated controlled environments”, Part 1: Classification of air Cleanliness , 1999.
4. United Status Department of Health and Human Services. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice. 2003.
5. ISPE Pharmaceutical Engineering Guide. Commissioning and Qualification. 2001.
6. CECMED. Anexo 4: Buenas Prácticas para la Fabricación de Productos Estériles, Regulación 16. 2000.
7. WHO Technical Report Series. No 902. Good Manufacturing Pratices for Sterile Pharmaceutical Products. 2002.
8. Schwartz Leonard. Heating. Ventilation, and Air Conditioning Considerations for Pharmaceutical Companies.Pharmaceutical Enginiering. 1994; 14(4):68-72.

 

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