Control of purified water supplied to the ABDALA vaccine

Authors

  • Alexander Hernández-Martínez Centro de Ingeniería Genética y Biotecnología, Habana, Cuba
  • Rebeca Vizcaíno-Zaballa Centro de Ingeniería Genética y Biotecnología, Habana, Cuba
  • Joel Ríos-Duque Centro de Ingeniería Genética y Biotecnología, Habana, Cuba
  • Caridad Gasmuri-González Centro de Ingeniería Genética y Biotecnología, Habana, Cuba

Keywords:

active pharmaceutical ingredient; vaccines; control; processes; purified water.

Abstract

The control of parameters and quality attributes in water systems is a permanent objective to guarantee the quality of pharmaceutical products, such as vaccines. The objective of this work is to control the quality of purified water supplied to the production of the Active Pharmaceutical Ingredient of the Abdala vaccine against the SARS-CoV-2 virus causing Covid 19. The methodology was structured as follows: establishment of sampling points, execution of tests, data processing and evaluation of trends in compliance with quality specifications. The conductivity results were below 1,3 μS/cm, the Total Organic Carbon between 8,16 and 200 μg/L, and the mesophilic aerobic count remained between 0 and 20 cfu/mL, with the absence demonstrated of pathogenic microorganisms, which allowed to ensure that the Purified Water System the supply to Abdala's production, remain with a state of control during monitoring time .

References

LIMONTA, M. Abdala: Primera vacuna anti-COVID-19 desarrollada y producida en América Latina. [fecha de consulta: 25/ 03/ 2022]. Disponible en https://www.salud.msp.gob.cu

CENTRO ESTATAL PARA EL CONTROL DE MEDICAMENTOS Y DISPOSITIVOS MÉDICOS CECMED. 2014. Anexo 06 de la Regulación 12-2012. Buenas Prácticas Ingenieras para la producción de aguas de uso Farmacéutico y vapor limpio.

WORLD HEALTH ORGANIZATION (WHO). Expert Committee on Specifications for Pharmaceutical Preparations: SRT 970. Forty Six Report Annex 2 Good manufacturing practice Water for Pharmaceutical Use 2012.

MONTANÉ, M. (2011). “Implementación de un sistema de gestión de procesos, en aguas de uso farmacéutico”. Tesis de Maestría. CIGB Habana.

UNITED PHARMACOPOEIA. NATIONAL FORMULARY SUPPLEMENT (USP43– NF34) Official Monographs. 2020. Chapter1231 Water for Pharmaceutical Purposes .Test 61 Microbial Enumeration, Test 63 Test for Specified Microorganisms, Test 643 Total Organic Carbon, Test 645 

Conductivity

ORGANIZACIÓN MUNDIAL DE LA SALUD (OMS). Buenas Prácticas de Laboratorio. Informe 44, Anexo 1, 2010.

COLLENTRO, W. (2011). Pharmaceutical water, an overview of USP Purified Water (I. Healthcare 2nd Ed. Vol. part II). New York, NY 10017, USA. ISBN 9781420077827.

INTERNATIONAL SOCIETY PRACTICE ENGINEERING (ISPE). Good Practice Guide Sampling for Pharmaceutical Water, Steam, and Process Gases. Retrieved from www.ispe.org. 2016 Copyright ISPE 2016.

MELTZER, THEODORE. Pharmaceutical Water: Generation, Storage, Distribution, and Quality Testing: 1999 Tall Oaks Pub. ISBN 978-0927188067.

DE LA CRUZ, T. et al. (2003). Aumento de la capacidad de producción de un sistema de agua purificada para la industria biofarmacéutica. Revista Noticias del Laboratorio. ISSN 1618-6915.

PROTOCOLO DE REVALIDACIÓN DE SISTEMA DE AGUA PURIFICADA No. 1, PVS02 CIGB, (2019).

THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS EMeA. “Position Statement on the quality of water used in the production of Vaccines”. Committee for proprietary medicinal products (CPMP). CPMP/BWP/1571/02. London. April 2002.

“Bosh Pharmaceutical water (PW and WFI) In stable Quality: A crucial material for vaccine production” [fecha de consulta: 22/ 02/ 2022]. Disponible en: https://www.dcvmn.orgbmg/bosch-pharma-water

DE LA CRUZ, T. et al. (2004 ). “Inyección de ozono: una opción ventajosa para sistemas de distribución de agua en la industria farmacéutica”. Revista CENIC Ciencias Químicas, 2004 35( 3), ISSN. 0254-0525.

LERÍN, I, et al. (2007 ). “Tratamiento de aguas. Sistemas de producción de aguas en la Industria Farmacéutica”. Farmaespaña industrial. Nov-Dic.

INTERNATIONAL COMMITTE HARMONIZATION (ICH). Harmonised Tripartite Guideline. Q7A Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients, 2000.

FOOD AND DRUG ADMINISTRATION (FDA). Note for Guidance on Quality of Water for Pharmaceutical Use. junio, 2002.

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Published

2022-10-25

How to Cite

Hernández-Martínez, A. ., Vizcaíno-Zaballa, R. ., Ríos-Duque, J. ., & Gasmuri-González, C. . (2022). Control of purified water supplied to the ABDALA vaccine. Revista Cubana De Química, 34(3). Retrieved from https://cubanaquimica.uo.edu.cu/index.php/cq/article/view/5266

Issue

Vol. 34 No. 3 (2022)

Section

Artículos

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Copyright (c) 2022 Alexander Hernández-Martínez, Rebeca Vizcaíno-Zaballa, Joel Ríos-Duque, Caridad Gasmuri-González

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