USD Conference Systems, International Conference on Sustainable Natural Products in Healthcare 2025

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Shipment Validation of Liquid and Semisolid Dosage Forms on Non-Cold Chain Finished Products in Pharma Industry
Renatha Chyntia Juni Pratami, Lucy Dewi Nurhajati Sasongko

Last modified: 2025-06-07

Abstract


The distribution phase is a key element in the pharmaceutical quality system, ensuring that products maintain their intended quality attributes until the point of use. In tropical regions like Indonesia, high ambient temperatures and logistical challenges highlight the need for rigorous distribution validation. This study investigates the stability of non-cold chain pharmaceutical dosage forms specifically liquid and semisolid formulations under worst-case distribution conditions. Post-distribution quality tests were conducted and compared with pre-distribution results to assess product stability. A 23-day simulated shipment to Manado City (North Sulawesi) via multimodal transport. Temperature profiling identified the hottest point in the container with an average temperature of 31.50 °C. During the actual shipment, data logger readings this critical point recorded an MKT of 31.78 °C, exceeding the WHO defined Controlled Room Temperature for zone IVb. Post-distribution quality testing showed no significant changes in liquid and semisolid dosage forms. A slight increase in viscosity was observed in both syrup and semisolid dosage forms following the distribution process. However, the measured values remained within the established specifications for finished products. These findings indicate that the transportation and distribution conditions did not significantly affect the physical stability of the formulations, and product quality was maintained throughout the distribution pathway.


Keywords


Mean kinetic temperature; non-cold chain; pharmaceutical distribution; transportation validation