نوع مقاله : مقاله کامل
نویسندگان
1 بخش کنترل کیفی واکسن‌های باکتریایی موسسه تحقیقات واکسن و سرم‌سازی رازی، سازمان تحقیقات، آموزش و ترویج کشاورزی، تهران، ایران
2 بخش تولید واکسن بروسلوز موسسه تحقیقات واکسن و سرم‌سازی رازی، سازمان تحقیقات، آموزش و ترویج کشاورزی، تهران، ایران
3 بخش کنترل کیفی و فیزیکوشیمیایی موسسه تحقیقات واکسن و سرم‌سازی رازی، سازمان تحقیقات، آموزش و ترویج کشاورزی، تهران، ایران
چکیده
کلیدواژه‌ها
عنوان مقاله [English]
نویسندگان [English]
Stability study of biological products plays an important role for determination of product changes in maintenance period and ensuring of safety and efficacy of vaccines. In this study longterm stability reduced-dose Rev.1 strain brucellosis vaccin that manufactured by Razi vaccine and serum research institute was evaluated. Sampling was conducted in accordance with references OIE 2015, and the samples after storage at 8-2 ° C and packaging conditions for 11 months, according to the vaccine package insert an interval of one month was tested for stability Real time. In this study, all tests quality control and physicochemical tests for evaluate the stability the vaccine for every 3 batches to 11 months after production was performed.For analyzing information from median, mean, variance, correlation and linear regression were used. The results of the study showed that all batches of studied, stable for 10 months in accordance with the requirements OIE 2015. If the conditions that all the requirements related to the preservation of vaccine including cold chain conditions should be observed. The vaccine can be stable for 10 months. Therefore, in accordance with the requirements OIE 2015, BP 2015 the expiration date of the vaccine can be increased from 4 months to 7 months.
کلیدواژه‌ها [English]
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