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Goat pox is one of the highly contagious viral diseases in goats. Iran is one of the endemic regions of the disease, and for many years, the vaccine produced at the RVSR Institute has been used to control this disease. Even though the vaccine strain has been isolated and attenuated in this Institute, but by the time and according to the changes in the requirements of the regulatory systems, new reliable documents to confirm the optimal quality of the vaccine is necessary . One of the required documents in the regulatory systems is the stability information, the lack of which is considered a major non-compliance.
In order to accurately determine the expiration date in which producer and consumer rights are considered, information is needed that is obtained and documented through stability studies. For this purpose, in this project, the stability of GPV goat pox vaccine was measured at specific temperatures and at specific time intervals in an accelerated and long-term manner. In this study, three consecutive batches of goat pox vaccine produced by Razi Institute with serial numbers 18101001, 18101002 and 18101003 were used after providing product storage chambers at 25 and 15 degrees. From each batch, 300 vials were considered for testing. 200 vials were stored at 4 degrees, 50 vials at 25 degrees and 50 vials at 15 degrees with 65% humidity. On the vials, titer, sterility, mycoplasma, safety, physicochemical tests were performed at specified times based on the VICH protocol.
Periodic tests were performed on three batches of vaccine stored at 4 degrees at time intervals of 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after production. Also, periodical tests were performed on three batches of vaccine stored at 25 degrees with humidity of 60 ± 5% at time intervals of 0, 1, 2, 3, 6, 7, 8 and 9 months after production, as well as the vaccines stored in 15 degrees were tested at intervals of 1, 3, 6, 9, 12 and 18 months.
The vaccines stored at 4 degrees and at the end of the test period 24 months) had very good sterility, mycoplasma, harmlessness, and physicochemical characteristics. Also, the vaccines stored at 25 and 15 degrees were completely favorable at the end of the test period in the mentioned indicators.
Since all measured indicators except the titer remain within the standard range for all temperatures and at all times, therefore, to determine the duration of vaccine stability, the vaccine titer as the main indicator was subjected to statistical analysis with Minitab software.
The results confirm the current expiration date of one year. Also, based on the fetal serum, this vaccine can be valid for more than one years.
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