Sterilization of solutions for parenterals products. Problem analysis
Abstract
The solutions for the formulation of parenteral products must be sterile before the aseptic formulation process. For this reason, different methods of sterilization referred in the literature are analyzed. Thermodynamic criteria that rule the sterilization are presented. Furthermore, previous experiences in the sterilization of solutions for the formulation of parental products in an autoclave are analyzed, that take large time of processing and only low volumes of solution can be handled. Using jacketed stirred tanks for the sterilization may solve the problem and, therefore, criteria for the design of the later that allow to process high volumes of solution for the formulation of parenteral products are shown.References
GARCÍA, I., “Penetración con reto "esterilización de gel de hidróxido de aluminio". 2013, Grupo Nacional de Validación. La Habana, Cuba
AGALLOCO, J. P.; AKERS, J. E..; MADSEN, R. E. "Moist Heat Sterilization- Myths and Realities". PDA Journal of Pharmaceutical Science and Technology, 1998. vol 52.
AGALLOCO, J.P., "Moist Heat Sterilization in Autoclave “Cycle Development, Validation and Routine Operation". Parenteral Drug Association Technical Report # 1. 2000.
CAPUTO, R.A.; ROHN, K.J. MACOLI, C.C. "Biological validation of an ethylene oxide sterilization process". Dev Indus Microbio, 1981. vol 22: p. 357–362.
EDWARDS, L.M.; CHILDERS, R.W. "Hydrogen peroxide vapor sterilization: Applications in the production environment". En GROVES M.J.; MURTY, R. (ed) Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s, Interpharm Press: Buffalo Grove, IL., 1995, p. 415–466.
PARENTERAL DRUG ASSOCIATION, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and ongoing Control. PDA Technical Report 1, Revised 2007.
PARENTERAL DRUG ASSOCIATION, Validation of Dry Heat Processes Used for Sterilization and Depyrogenation, PDA Technical Report 3. 1981.
SILVERMAN, G.J., Sterilization by ionizing radiation., En BLOCK, S.S. (ed) Disinfection, Sterilization and Preservation, Lea & Febiger: Philadelphia. 1991,. p. 566–579.
SARTORIUS STEDIM, Bioprocess Catalogue "Products and Solutions for the Biopharmaceutical Industry. https://www.sartorius.com/sartorius/en/EUR/bioprocess-solutions. 2006.
ISAACSON, R. Sterilization / validation, qualification requerimens. En Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors 2009. Nanjing, : World Health Organization.
MOTOLA, S., "Validation of Steam Sterilization Cycles". Parenteral Drug Association Technical Monograph No. 1.
PFLUG, I.J., "Heat Sterilization", En PHILLIPS, G.B.; MILLER, W.S. (ed) ,Industrial Sterilization, Duke University Press, Durham, NC. 1973.
ERNST, R.R.; WEST, K.L.; DOYLE, J.E., "Problem areas in sterility testing". Bull Parenter Drug Assoc, 1969. vol 23, p. 290-039.
KRUSHEFSKI, G. "Esterilización por vapor de contenedores llenos de líquido". Spore News, 2010. vol 7, núm 5. Octubre 2010. p, 6-8.
VALLADARES, G., "Penetración con reto de la carga 9 Esterilización del gel de hidróxido de aluminio". 2015, Grupo Nacional de Validación. La Habana, Cuba.
This work is licensed under the Creative Commons Attribution-NonCommercial.
Universidad de Oriente 