Stability study for determination of Expiry date of IRIBA vaccine.
2009
Hassan niya, Sayed Ebrahim | Maljaei , Sayed Vafa | Lotfi, Mohsen | Behrozikhah, Alimohammad | Alamian, Saeed | Ahmadinia, Sayed Reza | Hatami, Ali Reza
Stability test is one of the Q.C. tests using for checking expire date of vaccine. In this research ,vials of Iriba Vaccine manufactured by RVSRI from 3 batch (50 vials of each batch) were sampled randomly and they were stored in packing similar to packing of other vaccine vials that were stored at 4-8 C, then samples were tested in months 0,3,6,9,12,15,18,21 and 24 after manufacture. Total tests of Q.C. including CFU test , Purity, dissociation and Physicochemical testes such as : Appearance, Airtightness , Moisture content, Solubility, Extraneous agents,Vacuum test and quality of label were done in each period . Results of titration test were shown that three batches of vaccines until 12 month and third batch until 21 month after producing have a proved titer. Although results of CFU test , Purity, dissociation, 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 12 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 not conform the Exp. Date of vaccine (12 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 vaccines.
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