Stability Study of Measles AIK-C Strain, Mumps RS-۱۲ Strain and Rubella Takahashi Strain in MMR Vaccine

Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle and havea major impact on the success of immunization programs worldwide. The purpose of stability study isdetermination of the vaccine quality under the variety of environmental factors and to establish a re-testperiod or a shelf life and recommended storage conditions. In this study three batches of MMR vaccine ofRazi institute in Iran with AIK-C strain for measles, RS-۱۲ strain for mumps and Takahashi strain forrubella were tested for accelerated stability, after seven days incubation at ۳۷ °C and for long-term stabilitythe samples were stored at ۲-۸ °C and tested intervals in three months until ۳۶ months after production. Allof quantitative and qualitative control tests including Potency and Identity, Safety, Sterility, Mycoplasmaand Physicochemical tests were done in each period. In accelerated stability the mean loss of activity was۰.۳۷۵, ۰.۳۷۳ and ۰.۲۱۰ log۱۰ and in long-term stability the mean loss of activity was ۰.۶۲۶, ۰.۵۰ and ۰.۴۶log۱۰ for measles, mumps and rubella components of MMR vaccine respectively. In residual moisture testthe mean increase of moisture content in the vaccines was ۱.۰۸۴ %.In qualitative tests the vaccine met theWHO specifications too. Results of this research indicated the MMR vaccines with these strains are stableat least ۳۶ months if the cold chain considered properly.

Keywords:

MMR , Stability study , vaccine , Potency test , quality control