ACCELERATED STABILITY TESTING OF BIOPRODUCTS - ATTRACTIONS AND PITFALLS
ACCELERATED STABILITY TESTING OF BIOPRODUCTS - ATTRACTIONS AND PITFALLS
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DOI：
10.1016/0167-7799(94)90087-6
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发表时间：
1994-04-01
影响因子：
17.3
通讯作者：
FRANKS, F
中科院分区：
文献类型：
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作者：
FRANKS, F
加速试验广泛用于预测储存稳定性和质量，以及估计不稳定产品的保质期和“安全”储存温度。在食品、制药和生物工业中，产品通过高温测试来强调。然后将结果外推至“正常”储存条件。许多这样的产品以无定形固体存在，因此是热稳定的。在加速试验期间，此类产品可能发生剧烈和突然的物理和/或化学变化，从而使外推产生误导。了解加热过程中可能发生的物理变化，可以放心地进行加速试验。
Accelerated testing is widely used for the prediction of storage stability and quality, and for the estimation of shelf-lives and 'safe' storage temperatures of labile products. In the food, pharmaceutical and bioindustries, products are stressed by testing at high temperatures. The results are then extrapolated to 'normal' storage conditions. Many such products exist as amorphous solids and are therefore thermodynamically unstable. During accelerated testing, dramatic and sudden physical and/or chemical changes can occur within such products, rendering extrapolation misleading. A knowledge of possible physical changes during heating enables accelerated testing to be performed with confidence.