小瓶
印章(徽章)
材料科学
光谱学
激光器
色谱法
分析化学(期刊)
化学
光学
艺术
物理
量子力学
视觉艺术
作者
Tanya P. Lin,Chung C. Hsu,Bruce Kabakoff,Thomas W. Patapoff
出处
期刊:PubMed
日期:2004-04-29
卷期号:58 (2): 106-15
被引量:12
摘要
This study examined the feasibility of applying frequency-modulated spectroscopy (FMS) to test vacuum seal integrity of lyophilized protein pharmaceuticals in glass vials. A lyophilized recombinant monoclonal antibody was used as an example to demonstrate that FMS is a non-destructive method that could accurately and quickly determine vial vacuum integrity within a pressure range of 0.04 to 0.5 atm. The coefficient of determination (R2) of a bench-top instrument was found to be >0.99. Only seconds were required to analyze each sample. The instrument sensitivity and specificity were 0.95 and >0.99, respectively, based on analysis of approximately 40,000 samples. Because of low energy input by the instrument, no adverse effect on the protein quality was found immediately after up to 1 h of continuous laser exposure. The laser-exposed samples had comparable stability to non-exposed control vials after 12 weeks of storage at 40 degrees C.
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