Evaluation of disinfectants for use in the pharmaceutical environment

Authors

  • Leobel Fajardo Cedeño Empresa Laboratorio Farmacéutico Líquidos Orales, Medilip

DOI:

https://doi.org/10.30827/ars.v62i2.15713

Keywords:

disinfectants, effectiveness, usage tests, poured plate

Abstract

Introduction: Disinfectants are used in pharmaceutical companies to guarantee the reduction or elimination of microorganisms that may be present in production lines, equipment, personnel or the environment. Although the manufacturer guarantees their effectiveness, it is necessary to test them in the pharmaceutical environment where they are to be used.

Method: Three disinfectants were evaluated, NDP-Surfaplus in 70% concentration, NDP-Surfaclin in 2% and 0,5% concentration and Tristel Jet gel activated at 0,12% concentration. Swabs were performed before and after the application of the disinfectant to sections of wall surfaces, floors, marble plateaus and stainless-steel sinks. From each surface the sections that were most difficult to carry out the cleaning and disinfection processes were chosen. The counting method used was the poured plate method.

Results: The disinfectants were shown to meet the stipulated acceptance criteria with a 90% reduction in the initial microbial population, except for the 0,5% concentration of the NDP-Surfaclin disinfectant. A greater number of microorganisms were isolated on surfaces that had a tendency to form pores due to erosion from cleaning and disinfection processes, and it was also shown that disinfectants had a better activity on stainless steel surfaces.

Conclusions: The effectiveness of disinfectants in the pharmaceutical environment of the formulation line was demonstrated, approving their use for cleaning and disinfection processes. The best-performing disinfectant was NDP-Surfaplus at the 70% concentration.

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Author Biography

Leobel Fajardo Cedeño, Empresa Laboratorio Farmacéutico Líquidos Orales, Medilip

UEB Control de Calidad, Laborario de Microbiología, Especialista Principal de Laboratorio

References

Luppens SB, Reij MW, van der Heijden RW, Rombouts FM, Abee T. Development of a standard test to assess the resistance of Staphylococcus aureus biofilm cells to disinfectants. Appl Environ Microbiol. 2002 Sep;68(9):4194-200. doi: 10.1128/aem.68.9.4194-4200.2002

Ronner AB, Wong ACL. Biofilm Development and Sanitizer Inactivation of Listeria monocytogenes and Salmonella typhimurium on Stainless Steel and Buna-n Rubber. J Food Prot. 1993;56(9):750-758. doi: 10.4315/0362-028X-56.9.750.

Fleitas, A. Compuestos sanitizantes y sus propiedades. Limpieza y sanitización en plantas de alimentos. 1994. Bogotá, Asociación Química Colombiana.

Marritot, N. Marrito, N. Principios de higiene alimentaria. Editorial Acribia S.A Zaragoza, España, 2003, pp 153-167.

Rodríguez C. Validación de desinfectantes usados en las áreas de producción de la industria farmacéutica en Bogotá. Universidad Javeriana, Facultad de Ciencias, Bogotá,2002, 89

Medina Córdoba L, Valencia Mosquera K Ligia L. Evaluación de la eficacia de un desinfectante de alto nivel, a base de peróxido de hidrogeno, empleado en la esterilización de dispositivos e instrumentos hospitalarios. Pontificia universidad javeriana Facultad de ciencias Carrera de microbiología industrial 2008 disponible en:http://bibliomed.usac.edu.gt/sites/default/files/documentos/guia_vancouver_2016.pdf

United States Pharmacopeia 40, National Formulary 35. Test 1072 Antisépticos y desinfectantes, Rockville, Md., USA. The United States Pharmacopeial Convention, Inc. 2017. (versión electrónica).

Martínez, J.E 2006 What is Disinfectant Validation? Pharmaceutical Technology. 2006; 30(6)

United States Pharmacopeial 40. National Formulary 35Rockville, Md., USA. Convention, Inc. 2017. (versión electrónica). Test 1116. Control microbiológico y monitoreo de ambientes de procesamiento aséptico. Págs. 1571-1572

United States Pharmacopeial 40. National Formulary 35. Test 61. Limite microbiano Rockville, Md., USA. The United States Pharmacopeial Convention, Inc. 2017. (versión electrónica). Págs.172-178

United States Pharmacopeial 40. National Formulary 35Rockville, Md., USA. Convention, Inc. 2017. (versión electrónica). Test 1116. Control microbiológico y monitoreo de ambientes de procesamiento aséptico. Págs. 1571-1572

Davies, D. G., Parsek, M. R., Pearson, J. P., Iglewski, B. H., Costerton, J. W., y Greenberg, E. P. (1998) The involvement of cell-to-cell signals in the development of a bacterial biofilm, Science 280, 295-298.

Diomedi A, Chacón E, Delpiano L, Hervé B, Jemenao M.I, Medel M et al. Antisépticos y desinfectantes: apuntando al uso racional. Recomendaciones del Comité Consultivo de Infecciones Asociadas a la Atención de Salud, Sociedad Chilena de Infectología. Rev. chil. infectol. [Internet].2017; 34(2):156-174.Doi10.4067/S0716-10182017000200010.

McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999 Jan;12(1):147-79. Erratum in: Clin Microbiol Rev. 2001 ;14(1):227.

Sánchez-Saldaña L, Sáenz Anduaga E. Antisépticos y desinfectantes Dermatología Peruana 2005; 15 (2): 82-103.

Da Silva M, Ning C, Ghanbar S, Zhanel G, Logsetty S, Liu S. Evidence that novel quaternary compound and its organic N-chloramine derivative do not select for resistant mutants of Pseudomonas aeruginosa. J Hosp Infect 2015; 91 (1): 53-8.

Omidbakhsh N. Theoretical and experimental aspects of microbicidal activities of hard surface disinfectants: are their label claims based on testing under field conditions? JAOAC Int 2010; 93 (6): 1944-51.

Published

2021-03-22

How to Cite

1.
Fajardo Cedeño L. Evaluation of disinfectants for use in the pharmaceutical environment. Ars Pharm [Internet]. 2021 Mar. 22 [cited 2024 Jul. 22];62(2):175-81. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/15713

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Section

Original Articles