A review on the performance testing for transport packages of pharmaceutical products
10.11665/j.issn.1000-5048.20170619
- VernacularTitle:药品运输包装的性能测试浅析
- Author:
Handong NIU
1
;
Xiaoyan LIAN
;
Lei GAO
;
Yamin WANG
Author Information
1. 国家食品药品监督管理总局药品审评中心
- Keywords:
pharmaceutical development;
transport packages;
performance testing;
transportation risk;
ASTM D4169
- From:
Journal of China Pharmaceutical University
2017;48(6):751-758
- CountryChina
- Language:Chinese
-
Abstract:
The transport packages are primarily developed for transportation and storage,whose capabilities directly affect the product qualities during the circulation.During pharmaceutical development,the domestic pharmacy enterprises tend to put emphasis on the inner packing,but neglect the potential hazard elements in the distribution cycles and performance tests for transport packages of pharmaceutical products,which ultimately result in the disregard of hidden quality peril.This paper analyzes the necessity and significance ofthe performance tests for pharmaceuticals,follow by its domestic and overseas status.And then several testing standards for transport packages,especially ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems),are introduced in order to provide some suggestions of the performance testing for transport packages of pharmaceutical products.