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Calibration and Conformity in the Conductivity Channels of Pharmaceutical Waters Systems: A review

Author

Listed:
  • Adolfo Castillo Caballero
  • German Muñiz Jimenez
  • Luis A Calvo Diaz

    (Engineering Services Department, Center of Molecular Immunology, Cuba)

  • Idania Caballero Torres

    (Knowledge Management Department, Center of Molecular Immunology, Cuba)

  • Maria K Martinez Muné

    (Virology Department, Institute of Tropical Medicine “Pedro Kourí†, Cuba)

Abstract

Conductivity is an indicator of the quality in pharmaceutical water. Water systems are divided in two main groups of quality degree PW and WFI. There are two mainly ways to measure conductivity online and offline but the first is the one used for these systems. According with the GMP compliance, water systems are regularly subjected to validation processes, where the calibration of conductivity channel is a mandatory practice for performance qualification. Temperature effects must be considered when calibrating conductivity measuring channels. The conformity assessment in the calibration of the PW and WFI systems is proposed as criteria. As result the guidelines and monographies about all these topics are harmonized. An equipment or system of measurement to be reliable requires a conformity assessment with a probability greater than or equal to 95% for pharmaceutical industry.

Suggested Citation

  • Adolfo Castillo Caballero & German Muñiz Jimenez & Luis A Calvo Diaz & Idania Caballero Torres & Maria K Martinez Muné, 2018. "Calibration and Conformity in the Conductivity Channels of Pharmaceutical Waters Systems: A review," Global Journal of Pharmacy & Pharmaceutical Sciences, Juniper Publishers Inc., vol. 6(1), pages 3-11, July.
    • Handle: RePEc:adp:jgjpps:v:6:y:2018:i:1:p:3-11
    DOI: 10.19080/GJPPS.2018.06.555677
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