Study of long term stability of lived attenuated Goat pox vaccine produce by RVSRI.
2009
Kamal Zadeh, Morteza | Lotfi, Mohsen | Varshuei, Hamid Reza | Shirvani, Edris | Bahr Yari, Ma`sumeh | E`madi, Anahita
Stability test is one of the Q.C. tests that required to establish the validity of the expiry date that appears on the product package.In this research ,vials of Goat Pox Vaccine manufactured by RVSRI from 3 batch (90 vials of each batch) were sampled randomly and they were stored in packing similar to packing of other vaccine vials that were stored at 4-8C, then samples were tested in months 0¡4¡6¡8¡10¡12¡14 and 15 after manufacture. Total tests of Q.C. including Titration , Sterility, Mycoplasma, Safety on lab animals and Physicochemical testes such as : Appearance, Airtightness , Moisture content, Solubility, Extraneous agents and quality of label were done in each period . Results of titration test were shown that two batches of vaccines until 12 month and third batch until 14 month after producing have a proved titer. Although results of Sterility, Mycoplasma , Safety on lab animal on three batch were approved. Results at Physicochemical testes on three batch were shown a gradual increase in moisture content and following that a shrink lyophilized produce in vials of vaccine by passing of time. This change of appearance of vaccine was visible after 10 month. Additional tests were shown that rubber of vials with a low quality was the main cause of increasing of moisture . results of this research conform the Exp. Date of vaccine (8 month) on label . Although this study was shown stability of vaccine increases until 12 month after manufacturing if rubber of vials with high quality will be used similar to Imported vaccines.
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