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Research ArticleResearch

Demonstration of the Maintaining of the Validated State of a System Used to Generate Water for Injection by Thermocompression Distillation

Alberto Leyva, Iriac Bisquet, Tania De La Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte and Manuel Montané
PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 454-461; DOI: https://doi.org/10.5731/pdajpst.2017.007773
Alberto Leyva
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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  • For correspondence: alberto.leyva@cigb.edu.cu
Iriac Bisquet
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Tania De La Cruz
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Leoner Del Arco
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Joel Ríos
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Rodolfo Valdés
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Sonny Robles
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Fabian Ugarte
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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Manuel Montané
Engineering Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba
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References

  1. 1.↵
    1. Gsell G.,
    2. V. Nunez C.,
    3. Smith-Palmer M.
    Advances in Vapor Compression Technology for the Production of USP Purified Water and Water for Injection. Pharmaceutical Engineering 2013, 33 (2) 1–8.
    OpenUrl
  2. 2.↵
    U.S. Food and Drug Administration. Process Validation: General Principles and Practices, 2011, January.
  3. 3.↵
    EudraLex. Good Manufacturing Practice (GMP) Guidelines, Annex 15 Qualification and Validation, 2015, Vol. 4, March.
  4. 4.↵
    WHO Technical Report Series, No. 970, 2012. Annex 2 WHO Good Manufacturing Practices: Water for Pharmaceutical Use.
  5. 5.↵
    United States Pharmacopoeia 36—National Formulary 31; United States Pharmacopoeial Convention: Rockville, MD, 2013.
  6. 6.↵
    Water for Injection. In European Pharmacopoeia 5.0; European Pharmacopoeia Commission: Strasbourg, France, 2005; pp 2692–2694.
  7. 7.↵
    WHO Technical Report No. 929, 2005. Annex 3 WHO Good Manufacturing Practices: Water for Pharmaceutical Use.
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    Mantenimiento preventivo planificado asistido por computadora SGestMan. Website: www.gamma.com.cu/es/node/66.
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    General Chapter <645> Water Conductivity. In United States Pharmacopoeia 37—National Formulary 32; United States Pharmacopoeial Convention: Rockville, MD, 2014.
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    1. Barron J. J.,
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    The Effect of Temperature on Conductivity Measurement. TSP 2005, 7 (73), 1–5.
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    General Chapter <643> Total Organic Carbon. In United States Pharmacopoeia 37—National Formulary 32; United States Pharmacopoeial Convention: Rockville, MD, 2014.
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    2.2.44. TOC in Water for Pharmaceutical Use. In European Pharmacopoeia 5.0; European Pharmacopoeia Commission: Strasbourg, France, 2005.
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    . Total Organic Carbon as an Index for Specification of Water for Injection. J. Assoc. Off. Anal. Chem. 1987, 70 (4), 681–686.
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  14. 14.↵
    ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition), 2014.
  15. 15.↵
    1. Jahnke M.
    Microbiological Leak Test of Supply Pipes for Pharmaceutical Process Water. European J. Parenteral Sci. 2000, 5 (3), 75–78.
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    General Chapter <85> Bacterial Endotoxins Test In In United States Pharmacopoeia 37—National Formulary 32; United States Pharmacopoeial Convention: Rockville, MD, 2014.
  17. 17.↵
    1. Martínez J. E
    . Hyperthermophilic Microorganisms and USP Hot Water Systems. Pharm. Technol. 2004, 28 (2), 50–65.
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    1. Vincent D. W.
    Qualification of Purified Water Systems. J. Validation Technol. 2013, 10 (1), 50–61.
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PDA Journal of Pharmaceutical Science and Technology: 71 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 6
November/December 2017
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Demonstration of the Maintaining of the Validated State of a System Used to Generate Water for Injection by Thermocompression Distillation
Alberto Leyva, Iriac Bisquet, Tania De La Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte, Manuel Montané
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 454-461; DOI: 10.5731/pdajpst.2017.007773

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Demonstration of the Maintaining of the Validated State of a System Used to Generate Water for Injection by Thermocompression Distillation
Alberto Leyva, Iriac Bisquet, Tania De La Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte, Manuel Montané
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 454-461; DOI: 10.5731/pdajpst.2017.007773
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Keywords

  • Maintaining
  • Thermocompression
  • Validation
  • Water for injection

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