Examinando por Autor "Moreto Riofrio, Oscar Reinaldo"

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Buenas prácticas de distribución y transporte, manteniendo la cadena de frío 2°C a 8°C en productos terminados de Paclitaxel Paclitex®, Toxina Botulínica Cunox® y Octreotide Azestan®
(Universidad Privada Norbert Wiener, 2015) Moreto Riofrio, Oscar Reinaldo; Carhuapoma Yance, Mario
In the preservation of the cold chain, the weakest and most critical stage is undoubtedly transportation during the distribution of finished products. It is essential to identify suitable materials to maintain the cold chain through a series of tests, which must be documented to demonstrate that a certain quantity of Gel Ice Packs combined with appropriately sized Cold Boxes ensures temperature control within a predefined period. This guarantees compliance with good distribution and transportation practices. In this study, a method was developed to ensure the proper distribution and conservation of finished pharmaceutical products requiring a specific temperature of 2°C to 8°C to maintain their stability. Cold Boxes from different suppliers were purchased, evaluated, and compared to assess their performance in preserving the cold chain. Gel Ice Packs, accompanied by certificates describing their chemical composition and freezing point, were analyzed and approved by an authorized health network laboratory. Storage equipment and facilities used for products such as Paclitaxel PACLITEX®, Botulinum Toxin CUNOX®, and Octreotide AZESTAN® were calibrated, certified, and maintained under a periodic maintenance program. Field tests were conducted in three provinces with extreme seasonal temperatures. Based on the results of the first and second phases, an instructional guide was prepared for proper product packaging. Finally, the fourth and fifth tests were carried out in Callao and Lima, respectively, using optimal quantities and sizes of materials, with satisfactory results confirmed by temperature controllers (Temptale4) graphs.