Design, Development and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the Burkholderia cepacia Complex in Water with an Equivalence to ISO/TS 12869:2019

Huong Thu Duong; Shannon Fullbrook; Kate Reddington; Elizabeth Minogue; Thomas Barry

doi:10.5731/pdajpst.2021.012728

OtherTechnology/Application

Design, Development and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the Burkholderia cepacia Complex in Water with an Equivalence to ISO/TS 12869:2019

Huong Thu Duong, Shannon Fullbrook, Kate Reddington, Elizabeth Minogue and Thomas Barry

PDA Journal of Pharmaceutical Science and Technology February 2023, pdajpst.2021.012728; DOI: https://doi.org/10.5731/pdajpst.2021.012728

Huong Thu Duong

1 Nucleic Acid Diagnostics Laboratory, Microbiology, School of Natural Sciences, National University of Ireland Galway, Ireland;

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For correspondence: h.duong1@nuigalway.ie

Shannon Fullbrook

1 Nucleic Acid Diagnostics Laboratory, Microbiology, School of Natural Sciences, National University of Ireland Galway, Ireland;

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For correspondence: s.fullbrook1@nuigalway.ie

Kate Reddington

2 Microbial Diagnostics Research Laboratory, Microbiology, School of Natural Sciences, National University of Ireland Galway, Ireland

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For correspondence: kate.reddington@nuigalway.ie

Elizabeth Minogue

1 Nucleic Acid Diagnostics Laboratory, Microbiology, School of Natural Sciences, National University of Ireland Galway, Ireland;

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For correspondence: elizabeth.minogue@nuigalway.ie

Thomas Barry

1 Nucleic Acid Diagnostics Laboratory, Microbiology, School of Natural Sciences, National University of Ireland Galway, Ireland;

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For correspondence: thomas.barry@nuigalway.ie

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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Design, Development and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the Burkholderia cepacia Complex in Water with an Equivalence to ISO/TS 12869:2019

Huong Thu Duong, Shannon Fullbrook, Kate Reddington, Elizabeth Minogue, Thomas Barry

PDA Journal of Pharmaceutical Science and Technology Feb 2023, pdajpst.2021.012728; DOI: 10.5731/pdajpst.2021.012728

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Huong Thu Duong, Shannon Fullbrook, Kate Reddington, Elizabeth Minogue, Thomas Barry

PDA Journal of Pharmaceutical Science and Technology Feb 2023, pdajpst.2021.012728; DOI: 10.5731/pdajpst.2021.012728

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Keywords

Burkholderia cepacia complex
ISO/TS 12869:2019
culture-independent nucleic acid diagnostics
Finished pharmaceutical product recalls
Non-sterile aqueous pharmaceutical products
Water for manufacturing

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Design, Development and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the Burkholderia cepacia Complex in Water with an Equivalence to ISO/TS 12869:2019

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