مطالعه پایداری سویه AIK-C سرخک، سویه RS-12 اوریون و سویه Takahashi سرخجه در واکسن MMR

Abstract

Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle and have a major impact on the success of immunization programs worldwide. The purpose of stability study is determination of the vaccine quality under the variety of environmental factors and to establish a re-test period or a shelf life and recommended storage conditions. In this study three batches of MMR vaccine of Razi institute in Iran with AIK-C strain for measles, RS-12 strain for mumps and Takahashi strain for rubella were tested for accelerated stability, after seven days incubation at 37 °C and for long-term stability the samples were stored at 2-8 °C and tested intervals in three months until 36 months after production. All of quantitative and qualitative control tests including Potency and Identity, Safety, Sterility, Mycoplasma and Physicochemical tests were done in each period. In accelerated stability the mean loss of activity was 0.375, 0.373 and 0.210 log 10 and in long-term stability the mean loss of activity was 0.626, 0.50 and 0.46 log 10 for measles, mumps and rubella components of MMR vaccine respectively. In residual moisture test the mean increase of moisture content in the vaccines was 1.084 %.In qualitative tests the vaccine met the WHO specifications too. Results of this research indicated the MMR vaccines with these strains are stable at least 36 months if the cold chain considered properly.