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Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures

INTRODUCTION: The European Pharmacopoeia (Ph. Eur.) provides principles for microbiological testing of tissue preparations. According to the Ph. Eur., tests should be performed at different temperatures for detection of aerobic bacteria and fungi (20–25°C) vs. anaerobic bacteria (30–35°C). Semiautom...

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Autores principales: Herrlinger, Frithjof, Schulz, Tino, Pruß, Axel, Schulz, Eva
Formato: Online Artículo Texto
Lenguaje:English
Publicado: S. Karger GmbH 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923897/
https://www.ncbi.nlm.nih.gov/pubmed/33708049
http://dx.doi.org/10.1159/000513646
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author Herrlinger, Frithjof
Schulz, Tino
Pruß, Axel
Schulz, Eva
author_facet Herrlinger, Frithjof
Schulz, Tino
Pruß, Axel
Schulz, Eva
author_sort Herrlinger, Frithjof
collection PubMed
description INTRODUCTION: The European Pharmacopoeia (Ph. Eur.) provides principles for microbiological testing of tissue preparations. According to the Ph. Eur., tests should be performed at different temperatures for detection of aerobic bacteria and fungi (20–25°C) vs. anaerobic bacteria (30–35°C). Semiautomated systems using blood culture bottles are already widely used and they are adequate for growth detection. Resin-containing bottles and the addition of penicillinase permit testing of culture media containing antibiotics. MATERIALS AND METHODS: At 3 temperatures (21, 30, and 35°C) cornea culture media with and without dextran (CM II and CM I) and thermal disinfected femoral head medium (FH) were spiked with the 6 reference strains recommended by the Ph. Eur. (additionally: Enterococcus faecalis, Staphylococcus epidermidis, and Cutibacterium acnes). Microbial growth was monitored with the BACTEC(TM) FX unit or visually at 21°C. RESULTS: Growth for all strains was detected with each medium at all 3 temperatures, except for C. acnes at 21°C (all media) and 30°C with FH. C. acnes had the highest times to detection, requiring test durations of 14 days. Microbial growth was faster at 30 and 35°C compared to 21°C. CONCLUSION: The requirements according to the Ph. Eur. for a successful method suitability test could be fulfilled for the semiautomated blood culture bottle system with the BACTEC(TM) FX unit for the media and microorganisms used. In the presented validation study 35°C was shown to be the incubation temperature with the fastest growth, of the majority of the test strains used, and complete detection within 14 days.
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spelling pubmed-79238972021-03-10 Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures Herrlinger, Frithjof Schulz, Tino Pruß, Axel Schulz, Eva Transfus Med Hemother Research Article INTRODUCTION: The European Pharmacopoeia (Ph. Eur.) provides principles for microbiological testing of tissue preparations. According to the Ph. Eur., tests should be performed at different temperatures for detection of aerobic bacteria and fungi (20–25°C) vs. anaerobic bacteria (30–35°C). Semiautomated systems using blood culture bottles are already widely used and they are adequate for growth detection. Resin-containing bottles and the addition of penicillinase permit testing of culture media containing antibiotics. MATERIALS AND METHODS: At 3 temperatures (21, 30, and 35°C) cornea culture media with and without dextran (CM II and CM I) and thermal disinfected femoral head medium (FH) were spiked with the 6 reference strains recommended by the Ph. Eur. (additionally: Enterococcus faecalis, Staphylococcus epidermidis, and Cutibacterium acnes). Microbial growth was monitored with the BACTEC(TM) FX unit or visually at 21°C. RESULTS: Growth for all strains was detected with each medium at all 3 temperatures, except for C. acnes at 21°C (all media) and 30°C with FH. C. acnes had the highest times to detection, requiring test durations of 14 days. Microbial growth was faster at 30 and 35°C compared to 21°C. CONCLUSION: The requirements according to the Ph. Eur. for a successful method suitability test could be fulfilled for the semiautomated blood culture bottle system with the BACTEC(TM) FX unit for the media and microorganisms used. In the presented validation study 35°C was shown to be the incubation temperature with the fastest growth, of the majority of the test strains used, and complete detection within 14 days. S. Karger GmbH 2021-02 2020-12-16 /pmc/articles/PMC7923897/ /pubmed/33708049 http://dx.doi.org/10.1159/000513646 Text en Copyright © 2020 by S. Karger AG, Basel https://creativecommons.org/licenses/by-nc/4.0/ This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC). Usage and distribution for commercial purposes requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
spellingShingle Research Article
Herrlinger, Frithjof
Schulz, Tino
Pruß, Axel
Schulz, Eva
Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures
title Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures
title_full Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures
title_fullStr Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures
title_full_unstemmed Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures
title_short Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures
title_sort validation of microbiological testing of tissue preparations with different incubation temperatures
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923897/
https://www.ncbi.nlm.nih.gov/pubmed/33708049
http://dx.doi.org/10.1159/000513646
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