Thermal mapping and determination of monitoring points in drug storage
DOI:
https://doi.org/10.33448/rsd-v11i14.36375Keywords:
Temperature excursion; Deterioration of drugs; Thermal qualification; Stability of drugs; Dataloggers.Abstract
In order to retain medicine's quality levels up, it's necessary to store it according to the temperature and humidity specifications determined by the manufacturer, from its manufacturing date to its application on patients. Storages that hold these types of products make use of measuring instruments (thermohygrometers) that track temperature and humidity parameters on a daily basis. The objective of this study was to determine the quantity and location of monitoring points in a new storage, for this, initially a thermal qualification study was carried out, in order to verify the thermal distribution and identify the points that should be monitored. In this study, a thermal qualification was performed during a period of 168 (one hundred and sixty-eight) hours. Based on the results along with a general assessment of the storage, methodologies were established to determine optimal points for monitoring. According to the dimensions between each monitoring point in the area, it was concluded that 24 instruments were needed with an addition of 9 instruments to cover critical points for proper thermal qualification, for a total of 33 instruments to accurately monitor the temperature and humidity within the storage.
References
Alqurshi, A. (2020) Household storage of pharmaceutical products in Saudi Arabia; A call for utilising smart packaging solutions. Saudi Pharmaceutical Journal. 28: 1411–1419.
ANVISA – Agência Nacional de Vigilância Sanitária (2019) – RDC n° 318 de 6 de novembro de 2019. Estabelece os critérios para a realização de Estudos de Estabilidade de insumos farmacêuticos ativos e medicamentos, exceto biológicos, e dá outras providências. https://www.in.gov.br/web/dou/-/resolucao-rdc-n-318-de-6-de-novembro-de-2019-226513805.
ANVISA – Agência Nacional de Vigilância Sanitária (2020) – RDC n° 430 de 8 de outubro de 2020. Dispõe sobre as Boas Práticas de Distribuição, Armazenagem e de Transporte de Medicamentos. Diário Oficial da União. https://www.in.gov.br/en/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-430-de-8-de-outubro-de-2020-282070593.
Kumar, N., & Jha, A. (2017). Temperature excursion management: A novel approach of quality system in pharmaceutical industry. Saudi Pharmaceutical Journal, 25: 176-183.
Paoli, F., Bishara, R. H., & Asselt, E. J. (2021) How to define the right ambient temperature range for storage and distribution of pharmaceutical raw materials. Biologicals. 69: 66-69.
Pyatigorskaya, N. V., et al. (2018). Rationale for the Necessity of Temperature Mapping Of Storage Areas for Pharmaceutical Products. J. Pharm. Sci. & Res. 10: 662-664.
Pyatigorskaya, N. V., et al. (2018) Reducing the Number of Temperature Sensing Devices during Performance of Temperature Mapping. J. Pharm. Sci. & Res. 10: 2646-2650.
Silva, J. G. A., Neto, J. G. P., & Freire, R. A. (2020). Correlation between stability and medication storage conditions inside mobile emergency service (SAMU) ambulances. Brazilian Journal of Development. 6: 94622-94632.
Tabašević et al. (2020). Temperature mapping in pharmaceutical warehouse – Framework for pharmacy 4.0. In: X International Conference Industrial Engineering and Environmental. https://www.researchgate.net/profile/Mirjana-Misita/publication/346025002_TEMPERATURE_MAPPING_IN_PHARMACEUTICAL_WAREHOUSE_-_FRAMEWORK_FOR_PHARMACY_40/links/5fb6a2f1a6fdcc6cc64ae067/TEMPERATURE-MAPPING-IN-PHARMACEUTICAL-WAREHOUSE-FRAMEWORK-FOR-PHARMACY-40.pdf
WHO - World Health Organization (2011) - Annex 9. Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products: WHO Techinical Report Series, n. 961.
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