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A study on the contamination of injection bevacizumab on storage of multidose vials

PURPOSE: The aim of this study is to establish the safety of storage and reuse of bevacizumab vials for 1 week with multiple vial punctures. METHODS: This was an experimental microbiological study conducted at tertiary care hospital. The study samples included bevacizumab vials that had been used fo...

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Autores principales: Saoji, Ketan, Trehan, Hemant, Narayanan, Raja, Verma, Lalit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819106/
https://www.ncbi.nlm.nih.gov/pubmed/29380769
http://dx.doi.org/10.4103/ijo.IJO_969_16
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author Saoji, Ketan
Trehan, Hemant
Narayanan, Raja
Verma, Lalit
author_facet Saoji, Ketan
Trehan, Hemant
Narayanan, Raja
Verma, Lalit
author_sort Saoji, Ketan
collection PubMed
description PURPOSE: The aim of this study is to establish the safety of storage and reuse of bevacizumab vials for 1 week with multiple vial punctures. METHODS: This was an experimental microbiological study conducted at tertiary care hospital. The study samples included bevacizumab vials that had been used for injecting patients by the pooling method. Vials were stored and sampled in a manner that replicated their proposed clinical use. Contamination of vials was evaluated on the basis of microbial culture and validated by positive and negative controls. The probability of obtaining such results purely by chance was calculated. RESULTS: A total of 210 samples from 30 vials were evaluated along with 210 positive and 210 negative controls. No growth was seen in any of the bevacizumab samples. The probability of obtaining 210 consecutive sterile samples just by chance is <5.547 × 10(−6) (0.000005547). CONCLUSION: The vials showed no contamination on storage for 7 days in an ordinary refrigerator. Thus, we conclude that the rate of contamination of bevacizumab vials on storage for 7 days in a refrigerator is likely to be insignificant. The results need to be validated by other studies replicating this protocol.
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spelling pubmed-58191062018-02-22 A study on the contamination of injection bevacizumab on storage of multidose vials Saoji, Ketan Trehan, Hemant Narayanan, Raja Verma, Lalit Indian J Ophthalmol Original Article PURPOSE: The aim of this study is to establish the safety of storage and reuse of bevacizumab vials for 1 week with multiple vial punctures. METHODS: This was an experimental microbiological study conducted at tertiary care hospital. The study samples included bevacizumab vials that had been used for injecting patients by the pooling method. Vials were stored and sampled in a manner that replicated their proposed clinical use. Contamination of vials was evaluated on the basis of microbial culture and validated by positive and negative controls. The probability of obtaining such results purely by chance was calculated. RESULTS: A total of 210 samples from 30 vials were evaluated along with 210 positive and 210 negative controls. No growth was seen in any of the bevacizumab samples. The probability of obtaining 210 consecutive sterile samples just by chance is <5.547 × 10(−6) (0.000005547). CONCLUSION: The vials showed no contamination on storage for 7 days in an ordinary refrigerator. Thus, we conclude that the rate of contamination of bevacizumab vials on storage for 7 days in a refrigerator is likely to be insignificant. The results need to be validated by other studies replicating this protocol. Medknow Publications & Media Pvt Ltd 2018-02 /pmc/articles/PMC5819106/ /pubmed/29380769 http://dx.doi.org/10.4103/ijo.IJO_969_16 Text en Copyright: © 2018 Indian Journal of Ophthalmology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Original Article
Saoji, Ketan
Trehan, Hemant
Narayanan, Raja
Verma, Lalit
A study on the contamination of injection bevacizumab on storage of multidose vials
title A study on the contamination of injection bevacizumab on storage of multidose vials
title_full A study on the contamination of injection bevacizumab on storage of multidose vials
title_fullStr A study on the contamination of injection bevacizumab on storage of multidose vials
title_full_unstemmed A study on the contamination of injection bevacizumab on storage of multidose vials
title_short A study on the contamination of injection bevacizumab on storage of multidose vials
title_sort study on the contamination of injection bevacizumab on storage of multidose vials
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819106/
https://www.ncbi.nlm.nih.gov/pubmed/29380769
http://dx.doi.org/10.4103/ijo.IJO_969_16
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