Ludovica Borghesi¹, Giosiana Benesso Marco Redaelli¹ and Giovanni Abramo²*

¹Microbiological Laboratory Technician, Doppel Farmaceutici, Italy
²Microbiological Laboratory Head, Doppel Farmaceutici, Italy

*Corresponding Author: Giovanni Abramo, Microbiological Laboratory Head, Doppel Farmaceutici, Italy.

Received: May 10, 2024; Published: June 03, 2024

Abstract

Culture media represent the artificial substrates through which the development and in vitro growth of microorganisms are observed. They are characterized by specific ingredients (peptones, carbohydrates, salts, indicators, and solidifying agents) that aid in the growth of microorganisms. Furthermore, depending on the presence or absence of certain substances that promote the growth of only certain microorganisms, culture media are differentiated into selective and non-selective types. Currently, pre-prepared culture media are used and available commercially in the form of powders or dehydrated media, as well as ready-to-use media in plates, test tubes, or bottles. In the pharmaceutical field, according to the current regulations of the European Pharmacopoeia and the United States Pharmacopeia, culture media used for environmental monitoring and microbiological analysis of sterile and non-sterile products must undergo a growth promotion test (GPT) and verification of the sterility of the media before use. In this study, the nutritional characteristics of Tryptic Soy Agar (TSA) plates, with a diameter of 90 mm, were verified during passive air monitoring. The latter involves exposing the plates in the environment for a maximum of four hours to collect, by sedimentation, microorganisms carried by solid or liquid particles. The results obtained confirmed that the recovery for each microorganism on TSA plates meets the specifications required by the Pharmacopoeia for all time points tested (from T0 to T5). Furthermore, it was confirmed that, even after a five-hour exposure of the culture media under a laminar flow hood, a recovery rate exceeding 70% can be achieved. However, at this duration, dehydration phenomena and changes in the thickness of the media were observed; therefore, it is preferable to maintain a four-hour exposure time for the plates within clean rooms.

 Keywords: Growth Promotion Test; Recovery; Passive Sampling

References

1. Prescott LM., et al. “Microbiologie”. 5ème edition. Louvain-la-Neuve: De Boeck Supérieur; (2018).
2. Yu VL. “Serratia marcescens: historical perspective and clinical review”. The New England Journal of Medicine 300 (1979): 887-893.
3. Bonnet M., et al. “Bacterial culture through selective and non-selective conditions: the evolution of culture media in clinical microbiology”. New Microbes and New Infections 34 (2019).
4. Kumar S. “Textbook of microbiology”. New Delhi: JP Medical Ltd (2012).
5. Werkman CH and Wilson PW. “Bacterial physiology”. New-York: Academic Press Inc.; (1951).
6. Dunn MS., et al. “The amino acid requirements of twenty-three lactic acid bacteria”. Journal of Biological Chemistry 168 (1947): 1-22.
7. International Organization for Standardization (ISO) <11133:2014>. Microbiology of food, animal feed and water – Preparation, production, storage and performance testing of culture media. Versione (2014).
8. Food and Drug Administration, Office of Regulatory Affairs. Document Number: ORA 007 (2020).
9. Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, 2004. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA).
10. <1227> Validation of microbial recovery from Pharmacopeial articles (2012).
11. Tim Sandle. “Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial growth”. European Journal of Parenteral and Pharmaceutical Sciences2 (2015).
12. European Commission. The Rules Governing Medicinal Products in the European Union. Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Annex 1; Manufacture of Sterile Medicinal Products. 14 (2022).

Citation

Citation: Giovanni Abramo., et al. “The Neonates' Body Length and Body Weight in Two Different Periods of Time”.Acta Scientific Medical Sciences 8.7 (2024): 03-09.

Copyright

Copyright: © 2024 Giovanni Abramo., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.