<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2224-5421</journal-id>
<journal-title><![CDATA[Revista Cubana de Química]]></journal-title>
<abbrev-journal-title><![CDATA[Rev Cub Quim]]></abbrev-journal-title>
<issn>2224-5421</issn>
<publisher>
<publisher-name><![CDATA[Ediciones UO, Universidad de Oriente]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2224-54212022000300403</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Control del agua purificada suministrada a la vacuna ABDALA]]></article-title>
<article-title xml:lang="en"><![CDATA[Control of purified water supplied to the ABDALA vaccine]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-Martínez]]></surname>
<given-names><![CDATA[Alexander]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vizcaíno-Zaballa]]></surname>
<given-names><![CDATA[Rebeca]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ríos-Duque]]></surname>
<given-names><![CDATA[Joel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gasmuri-González]]></surname>
<given-names><![CDATA[Caridad]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Ingeniería Genética y Biotecnología  ]]></institution>
<addr-line><![CDATA[Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2022</year>
</pub-date>
<volume>34</volume>
<numero>3</numero>
<fpage>403</fpage>
<lpage>421</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2224-54212022000300403&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2224-54212022000300403&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2224-54212022000300403&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El control de parámetros y atributos de calidad en los sistemas de agua es un objetivo permanente para garantizar la calidad de productos farmacéuticos, como las vacunas. El objetivo del trabajo es controlar la calidad del agua purificada que se suministra a la producción del ingrediente farmacéutico activo de la vacuna Abdala contra el virus SARS-CoV-2 causante de la Covid 19. La metodología se estructuró en: establecimiento de puntos de muestreo, ejecución de ensayos; procesamiento de datos y evaluación de tendencias en el cumplimiento de las especificaciones de calidad. Los resultados de conductividad estuvieron por debajo de 1,3 µS/cm, los de carbono orgánico total entre 8,16 y 200 µg/L, y el conteo de aerobios mesófilos se mantuvo entre 0 y 20 ufc/mL, con demostrada ausencia de microorganismos patógenos; que permitió asegurar que el sistema que suministra agua purificada a la producción de Abdala permanece en estado de control durante el tiempo monitoreado.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[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 .]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[ingrediente farmacéutico activo]]></kwd>
<kwd lng="es"><![CDATA[vacunas]]></kwd>
<kwd lng="es"><![CDATA[control]]></kwd>
<kwd lng="es"><![CDATA[procesos]]></kwd>
<kwd lng="es"><![CDATA[agua purificada]]></kwd>
<kwd lng="en"><![CDATA[active pharmaceutical ingredient]]></kwd>
<kwd lng="en"><![CDATA[vaccines]]></kwd>
<kwd lng="en"><![CDATA[control]]></kwd>
<kwd lng="en"><![CDATA[processes]]></kwd>
<kwd lng="en"><![CDATA[purified water]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="">
<person-group person-group-type="author">
<name>
<surname><![CDATA[LIMONTA]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
</person-group>
<source><![CDATA[Abdala: Primera vacuna anti-COVID-19 desarrollada y producida en América Latina]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="">
<collab>CENTRO ESTATAL PARA EL CONTROL DE MEDICAMENTOS Y DISPOSITIVOS MÉDICOS CECMED</collab>
<source><![CDATA[Anexo 06 de la Regulación 12-2012. Buenas Prácticas Ingenieras para la producción de aguas de uso Farmacéutico y vaporlimpio]]></source>
<year>2014</year>
</nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="">
<collab>WORLD HEALTH ORGANIZATION (WHO)</collab>
<source><![CDATA[Expert Committee on Specifications for Pharmaceutical Preparations: SRT 970. Forty Six Report Annex 2 Good manufacturing practice Water for Pharmaceutical Use]]></source>
<year>2012</year>
</nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[MONTANÉ]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
</person-group>
<source><![CDATA[Implementación de un sistema de gestión de procesos, en aguas de uso farmacéutico]]></source>
<year>2011</year>
<publisher-loc><![CDATA[Habana ]]></publisher-loc>
<publisher-name><![CDATA[CIGB]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="">
<collab>UNITED PHARMACOPOEIA</collab>
<source><![CDATA[NATIONAL FORMULARY SUPPLEMENT (USP43- NF34) Official Monographs]]></source>
<year>2020</year>
</nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="">
<collab>ORGANIZACIÓN MUNDIAL DE LA SALUD (OMS)</collab>
<source><![CDATA[Buenas Prácticas de Laboratorio]]></source>
<year>2010</year>
</nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[COLLENTRO]]></surname>
<given-names><![CDATA[W.]]></given-names>
</name>
</person-group>
<source><![CDATA[Pharmaceutical water, an overview of USP Purified Water]]></source>
<year>2011</year>
<edition>2</edition>
<publisher-loc><![CDATA[New York, NY 10017, USA ]]></publisher-loc>
<publisher-name><![CDATA[I. Healthcare]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="">
<collab>INTERNATIONAL SOCIETY PRACTICE ENGINEERING (ISPE)</collab>
<source><![CDATA[Good Practice Guide Sampling for Pharmaceutical Water, Steam, and Process Gases]]></source>
<year>2016</year>
</nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="book">
<collab>MELTZER, THEODORE</collab>
<source><![CDATA[Pharmaceutical Water: Generation, Storage, Distribution, and Quality Testing]]></source>
<year>1999</year>
<publisher-name><![CDATA[Tall Oaks Pub]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[DE LA CRUZ]]></surname>
<given-names><![CDATA[T.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Aumento de la capacidad de producción de un sistema de agua purificada para la industria biofarmacéutica]]></article-title>
<source><![CDATA[Revista Noticias del Laboratorio]]></source>
<year>2003</year>
<page-range>1618-6915</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="book">
<source><![CDATA[PROTOCOLO DE REVALIDACIÓN DE SISTEMA DE AGUA PURIFICADA No. 1, PVS02]]></source>
<year>2019</year>
<publisher-name><![CDATA[CIGB]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="book">
<collab>THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS EMeA</collab>
<source><![CDATA[Position Statement on the quality of water used in the production of Vaccines]]></source>
<year>2002</year>
<publisher-loc><![CDATA[London ]]></publisher-loc>
<publisher-name><![CDATA[Committee for proprietary medicinal products (CPMP). CPMP/BWP/1571/02]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B13">
<label>13</label><nlm-citation citation-type="">
<source><![CDATA[Bosh Pharmaceutical water (PW and WFI) In stable Quality: A crucial material for vaccine production]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B14">
<label>14</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[DE LA CRUZ]]></surname>
<given-names><![CDATA[T.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Inyección de ozono: una opción ventajosa para sistemas de distribución de agua en la industria farmacéutica]]></article-title>
<source><![CDATA[Revista CENIC Ciencias Químicas]]></source>
<year>2004</year>
<volume>35</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>0254-525</page-range></nlm-citation>
</ref>
<ref id="B15">
<label>15</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[LERÍN]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Tratamiento de aguas. Sistemas de producción de aguas en la Industria Farmacéutica]]></article-title>
<source><![CDATA[Farmaespaña industrial]]></source>
<year>2007</year>
</nlm-citation>
</ref>
<ref id="B16">
<label>16</label><nlm-citation citation-type="">
<collab>INTERNATIONAL COMMITTE HARMONIZATION (ICH). Harmonised Tripartite Guideline. Q7A</collab>
<source><![CDATA[Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients]]></source>
<year>2000</year>
</nlm-citation>
</ref>
<ref id="B17">
<label>17</label><nlm-citation citation-type="">
<collab>FOOD AND DRUG ADMINISTRATION (FDA)</collab>
<source><![CDATA[Note for Guidance on Quality of Water for Pharmaceutical Use]]></source>
<year>2002</year>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
