Ng Chun Zheng, Lean Yen Loong, Yeoh Siang Fei, Lean Qi Ying, Lee Kah Seng, Suleiman Amal Khalil, Liew Kai Bin, Kassab Yaman Walid, Al-Worafi Yaser Mohammed, Ming Long Chiau
Faculty of Pharmacy, Quest International University Perak, Ipoh, Malaysia.
Department of Pharmacy, National University Health System, Singapore, Singapore.
Clin Exp Vaccine Res. 2020 Jan;9(1):8-14. doi: 10.7774/cevr.2020.9.1.8. Epub 2020 Jan 31.
The objective of this research was to examine the cold chain temperature maintenance for the supply of vaccines and other biological products by pharmaceutical wholesaler.
In this study, six configurations using cold vaccine boxes or bags made with different materials, with and without insulation, of different sizes, and number of coolant-packs were used to simulate the configuration used by the pharmaceutical wholesalers for transportation of vaccine. Model vaccines (vial, n=10) were packed using these six configurations which then stored in an incubator at 38℃ and monitored for 24 hours. Each configuration was tested repeatedly for 5 times.
In term of compliance to 2℃-8℃, four out of six tested configurations are effective in cold chain transportation. The effectiveness is highly dependent on the type of passive containers used, size of cold boxes, insulation, and number of coolant-packs. The configuration with a larger polystyrene foam box with five coolant-packs maintained the required temperature up to 23 hours. In contrast, configurations using a polystyrene foam box with four coolant-packs and a large vaccine cold box with two coolant-packs failed to reach below 8℃ throughout the 24 hours.
Packaging method, the material and size of the container could have a direct impact on the effectiveness of cold chain temperature maintenance. Polystyrene foam box, cold box with polyethylene interior lining and polypropylene insulation, a cooler bag with proper number of ice packs could be effectively used for transportation of vaccines within their respective transportation duration allowance.
本研究的目的是检验药品批发商在供应疫苗和其他生物制品时冷链温度的维持情况。
在本研究中，使用了六种配置，这些配置采用了不同材料制成的冷藏疫苗箱或袋子，有隔热和无隔热、不同尺寸以及不同数量的冷却包，以模拟药品批发商运输疫苗时使用的配置。使用这六种配置包装模型疫苗（小瓶，n = 10），然后将其储存在38℃的培养箱中并监测24小时。每种配置重复测试5次。
就符合2℃-8℃而言，六种测试配置中有四种在冷链运输中是有效的。有效性高度依赖于所使用的被动容器类型、冷藏箱尺寸、隔热以及冷却包数量。带有五个冷却包的较大聚苯乙烯泡沫箱配置在长达23小时内维持了所需温度。相比之下，使用带有四个冷却包的聚苯乙烯泡沫箱和带有两个冷却包的大型疫苗冷藏箱的配置在24小时内均未能达到8℃以下。
包装方法、容器的材料和尺寸可能对冷链温度维持的有效性产生直接影响。聚苯乙烯泡沫箱、带有聚乙烯内衬和聚丙烯隔热层的冷藏箱、带有适量冰袋的冷却袋可在各自的运输时长允许范围内有效地用于疫苗运输。
