Evaluation of long term stability study test for infectious Bronchitis vaccine (H120)manufactured by Razi institute.
2007
Mojahedi, Zohreh | Masudi, S. | Qodsiyan, Naser | Ebrahimi, Reza | Shiri, Nadiyeh
In order to access assurance for vaccines&rsquoquality it&rsquos required that the vaccines have minimum protective dose during the expiry date and the documents about stability study should be presented by manufacturer. One of the quality control department tasks is to determine vaccines expiry date, as well. So this would be carried out by stability study test. In the other hand it must be run every year. In this study in which that determination of the stability of infectious bronchitis vaccine (H120) is the aim, according to the pre-determined protocol definite numbers of 3 batches of bronchitis vaccine manufactured by RVRI were selected and stored in 4؛C. Considering present experiences in this filed and effective points on vaccine quality, vaccine physicochemical(appearance, moisture and solubility) and titration tests were selected as the most important test, then in interval period -every 3 months- for 27 months, the titer of vaccine was calculated by SPF eggs injection and Kerber&rsquos method. The results presented this vaccine kept up appearance, acceptable moisture and minimum protective titer for 7 months after expiry date. Therefore as well as vaccine stability assurance during the expiry date, the date can be increased from 14 to 18 months.
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